Continuous electronic fetal heart rate monitoring (EFM) is used in the vast majority of all labors in the United States. With the use of EFM categories and definitions from the American College of Obstetricians and Gynecologists, the National Institutes of Health, and the Society for Maternal-Fetal Medicine, clinicians can now better define and communicate tracing assessments. Except for reducing neonatal seizure activity, however, EFM use during labor has not been demonstrated to significantly improve fetal and neonatal outcomes, yet EFM is associated with an increase in cesarean deliveries and instrument-assisted vaginal births.¹

The negative predictive value of EFM for fetal hypoxia/acidosis is high, but its positive predictive value is only 30%, and the false-positive rate is as high as 60%.² Although a false-positive assessment may result in a potentially unnecessary operative vaginal or cesarean delivery, a falsely reassuring strip may produce devastating consequences in the newborn and, not infrequently, medical malpractice liability. One etiology associated with falsely reassuring assessments is that of EFM monitoring of the maternal heart rate and the failure to recognize the tracing as maternal.

In this article, I discuss the mechanisms and periods of labor that often are associated with the maternal heart rate masquerading as the fetal heart rate. I review common EFM patterns associated with the maternal heart rate so as to aid in recognizing the maternal heart rate. In addition, I provide 3 case scenarios that illustrate the simple yet critical steps that clinicians can take to remedy the situation. Being aware of the potential for a maternal heart rate recording, investigating the EFM signals, and correcting the monitoring can help prevent significant morbidity.

CASE 1 EFM shows seesaw decelerations and returns to baseline rate

A 29-year-old woman (G3P2) at 39 weeks’ gestation was admitted to the hospital with spontaneous labor. Continuous EFM external monitoring was initiated. After membranes spontaneously ruptured at 4 cm dilation, an epidural was placed. Throughout the active phase of labor, the fetus demonstrated intermittent mild variable decelerations, and the fetal heart rate baseline increased to 180 beats per minute (BPM). With complete dilation, the patient initiated pushing. During the first several pushes, the EFM demonstrated an initial heart rate deceleration, and a loss of signal, but the heart rate returned to a baseline rate of 150 BPM. With the patient’s continued pushing efforts, the EFM baseline increased to 180 BPM, with evidence of variable decelerations to a nadir of 120 BPM, although with some signal gaps (FIGURE 1, red arrow). The tracing then appeared to have a baseline of 120 BPM with variability or accelerations (FIGURE 1, green arrow) before shifting again to 170 to 180 BPM.

What was happening?

Why does the EFM record the maternal heart rate?

Most commonly, EFM recording of the maternal heart rate occurs during the second stage of labor. Early in labor, the normal fetal heart rate (110–160 BPM) typically exceeds the basal maternal heart rate. However, in the presence of chorioamnionitis and maternal fever or with the stress of maternal pushing, the maternal heart rate frequently approaches or exceeds that of the fetal heart rate. The maximum maternal heart rate can be estimated as 220 BPM minus the maternal age. Thus, the heart rate in a 20-year-old gravida may reach rates of 160 to 180 BPM, equivalent to 80% to 90% of her maximum heart rate during second-stage pushing.

The external Doppler fetal monitor, having a somewhat narrow acoustic window, may lose the focus on the fetal heart as a result of descent of the baby, the abdominal shape-altering effect of uterine contractions, and the patient’s pushing. During the second stage, the EFM may record the maternal heart rate from the uterine arteries. Although some clinicians claim to differentiate the maternal from the fetal heart rate by the “whooshing” maternal uterine artery signal as compared with the “thumping” fetal heart rate signal, this auditory assessment is unproven and likely unreliable.

CASE 1 Problem recognized and addressed

In this case, the obstetrician recognized that “slipping” from the fetal to the maternal heart rate recording occurred with the onset of maternal pushing. After the pushing ceased, the maternal heart rate slipped back to the fetal heart rate. With the next several contractions, only the maternal heart rate was recorded. A fetal scalp electrode was then placed, and fetal variable decelerations were recognized. In view of the category II EFM recording, a vacuum procedure was performed from +3 station and a female infant was delivered. She had Apgar scores of 6 and 8 at 1 and 5 minutes, respectively, and she did well in the nursery.

Read what happened in Case 2 when the EFM demonstrated breaks in the tracing

CASE 2 EFM tracings belie the clinical situation

A 20-year-old woman (G1P0) presented for induction of labor at 41 weeks’ gestation. Continuous EFM recording was initiated, and the patient was given dinoprostone and, subsequently, oxytocin. Rupture of membranes at 3 cm demonstrated a small amount of fluid with thick meconium. The patient progressed to complete dilation and developed a temperature of 38.5°C; the EFM baseline increased to 180 BPM. Throughout the first hour of the second stage of labor, the EFM demonstrated breaks in the tracing and a heart rate of 130 to 150 BPM with each pushing effort (FIGURE 2A). The Doppler monitor was subsequently adjusted to focus on the fetal heart and repetitive late decelerations were observed (FIGURE 2B). An emergent cesarean delivery was performed. A depressed newborn male was delivered, with Apgar scores of 2 and 4 at 1 and 5 minutes, respectively, and significant metabolic acidosis.

What happened?

Fetal versus maternal responses to pushing

The fetal variable deceleration pattern is well recognized by clinicians. As a result of umbilical cord occlusion (due to compression, stretching, or twisting of the cord), fetal variable decelerations have a typical pattern. An initial acceleration shoulder resulting from umbilical vein occlusion (due to reduced venous return) is followed by an umbilical artery occlusion–induced sharp deceleration. The relief of the occlusion allows the sharp return toward baseline with the secondary shoulder overshoot.

In some cases, partial umbilical cord occlusion that affects only the fetal umbilical vein may result in an acceleration, although these usually resolve or evolve into variable decelerations within 30 minutes. By contrast, the maternal heart rate typically increases with contractions and with maternal pushing efforts. Thus, a repetitive pattern of heart rate accelerations with each contraction should warn of a possible maternal heart rate recording.

How maternal heart rate responds to pushing. Maternal pushing is a Valsalva maneuver. Although there are 4 classic cardiovascular phases of Valsalva responses, the typical maternal pushing effort results in an increase in the maternal heart rate. With the common sequence of three 10-second pushes during each contraction, the maternal heart rate often exhibits 3 acceleration and deceleration responses. The maternal heart rate tracing looks similar to the shape of the Three Sisters mountain peaks in Oregon (FIGURE 3). Due to Valsalva physiology, the 3 peaks of the Sisters mirror the 3 uterine wave form peaks, although with a 5- to 10-second delay in the heart rate responses (mountain peaks) from the pushing efforts.

Pre- and postcontraction changes offer clues. Several classic findings aid in differentiating the maternal from the fetal heart rate. If the tracing is maternal, typically the heart rate gradually decreases following the end of the contraction/pushing and continues to decrease until the start of the next contraction/pushing, at which time it increases. During the push, the Three Sisters wave form, with the 5- to 10-second offset, should alert the clinician to possible maternal heart rate recordings. By contrast, the fetal heart rate variable deceleration typically increases following the end of the maternal contraction/pushing and is either stable or increases further (variable with slow recovery) prior to the next uterine contraction/pushing effort. These differences in the patterns of precontraction and postcontraction changes can be very valuable in differentiating periods of maternal versus fetal heart rate recordings.

With “slipping” between fetal and maternal recording, it is not uncommon to record fetal heart rate between contractions, slip to the maternal heart rate during the pushing effort, and return again to the fetal heart rate with the end of the contraction. When confounded with the potential for other EFM artifacts, including doubling of a low maternal or fetal heart rate, or halving of a tachycardic signal, it is not surprising that it is challenging to recognize an EFM maternal heart rate recording.

CASE 2 Check the monitor for accurate focus

A retrospective analysis of this case revealed that the maternal heart rate was recorded with each contraction throughout the second stage. The actual fetal heart rate pattern of decelerations was revealed with the refocusing of the Doppler monitor.

Read how subtle slipping manifested in the EFM tracing of Case 3

CASE 3 Low fetal heart rate and variability during contractions

A 22-year-old woman (G2P1) in spontaneous labor at term progressed to complete dilation. Fetal heart rate accelerations occurred for approximately 30 minutes. With the advent of pushing, the fetal heart rate showed a rate of 130 to 140 BPM and mild decelerations with each contraction (FIGURE 4A). As the second stage progressed, the tracing demonstrated an undulating baseline heart rate between 100 and 130 BPM with possible variability during contractions (FIGURE 4B). This pattern continued for an additional 60 minutes. At vaginal delivery, the ObGyn was surprised to deliver a depressed newborn with Apgar scores of 1 and 3 at 1 and 5 minutes, respectively.

Slipping from the fetal to the maternal heart rate may be imperceptible

In contrast to the breaks in the tracings seen in Case 1 and Case 2, the EFM tracing in Case 3 appears continuous. Yet, slipping from the fetal to the maternal recording was occurring.

As seen in FIGURE 4C, the maternal heart rate with variability was recorded during pushing efforts, and the fetal heart rate was seen rising back toward a baseline between contractions. Note that the fetal heart rate did not reach a level baseline, but rather decelerated with the next contraction. The slipping to the maternal heart rate occurred without a perceptible break in the recording, making this tracing extremely difficult to interpret.

CASE 3 Be ever vigilant

The lack of recognition that the EFM recording had slipped to the maternal heart rate resulted in fetal and newborn hypoxia and acidosis, accounting for the infant’s low Apgar scores.

Read how using 3 steps can help you distinguish fetal from maternal heart rate patterns

Follow 3 steps to discern fetal vs maternal heart rate

These cases illustrate the difficulties in recognizing maternal heart rate patterns on the fetal monitor tracing. The 3 simple steps described below can aid in differentiating maternal from fetal heart rate patterns.

1 Be aware and alert

Recognize that EFM monitoring of the maternal heart rate may occur during periods of monitoring, particularly in second-stage labor. Often, the recorded tracing is a mix of fetal and maternal patterns. Remember that the maternal heart rate may increase markedly during the second stage and rise even higher during pushing efforts. When presented with a tracing that ostensibly represents the fetus, it may be challenging for the clinician to question that assumption. Thus, be aware that tracings may not represent what they seem to be.

Often, clinicians view only the 10-minute portion of the tracing displayed on the monitor screen. I recommend, however, that clinicians review the tracing over the past 30 to 60 minutes, or since their last EFM assessment, for an understanding of the recent fetal baseline heart rate and decelerations.

2 Investigate

Although it is sometimes challenging to recognize EFM maternal heart rate recordings, this is relatively easy to investigate. Even without a pulse oximeter in place, carefully examine the EFM recording for maternal signs to determine if the maternal heart rate is within the range of the recording. You can confirm that the recording is maternal through 1 of 3 easy measures:

• First, check the maternal radial pulse and correlate it with the heart rate baseline.
• Second, place a maternal electrocardiographic (EKG) heart rate monitor.
• Last, and often the simplest approach for continuous tracings, place a finger pulse oximeter to provide a continuous maternal pulse reading. Should the maternal heart rate superimpose on the EFM recording, maternal patterns are likely being detected. However, since the pulse oximeter and EFM Doppler devices use different technologies, they will provide similar—but not precisely identical—heart rate numerical readings if both are assessing the maternal heart rate. In that case, take steps to assure that the EFM truly is recording the fetal heart rate.

3 Treat and correct

If the EFM is recording a maternal signal or if a significant question remains, place a fetal scalp electrode (unless contraindicated), as this may likely occur during the second stage. Alternatively, place a maternal surface fetal EKG monitor, or use ultrasonography to visually assess the fetal heart rate in real time.

Key point summary

The use of a maternal finger pulse oximeter, combined with a careful assessment of the EFM tracing, and/or a fetal scalp electrode are appropriate measures for confirming a fetal heart rate recording.

The 3 steps described (be aware and alert, investigate, treat and correct) can help you effectively monitor the fetal heart rate and avoid the potentially dangerous outcomes that might occur when the maternal heart rate masquerades as the fetal heart rate.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Continuous electronic fetal heart rate monitoring (EFM) is used in the vast majority of all labors in the United States. With the use of EFM categories and definitions from the American College of Obstetricians and Gynecologists, the National Institutes of Health, and the Society for Maternal-Fetal Medicine, clinicians can now better define and communicate tracing assessments. Except for reducing neonatal seizure activity, however, EFM use during labor has not been demonstrated to significantly improve fetal and neonatal outcomes, yet EFM is associated with an increase in cesarean deliveries and instrument-assisted vaginal births.¹

The negative predictive value of EFM for fetal hypoxia/acidosis is high, but its positive predictive value is only 30%, and the false-positive rate is as high as 60%.² Although a false-positive assessment may result in a potentially unnecessary operative vaginal or cesarean delivery, a falsely reassuring strip may produce devastating consequences in the newborn and, not infrequently, medical malpractice liability. One etiology associated with falsely reassuring assessments is that of EFM monitoring of the maternal heart rate and the failure to recognize the tracing as maternal.

In this article, I discuss the mechanisms and periods of labor that often are associated with the maternal heart rate masquerading as the fetal heart rate. I review common EFM patterns associated with the maternal heart rate so as to aid in recognizing the maternal heart rate. In addition, I provide 3 case scenarios that illustrate the simple yet critical steps that clinicians can take to remedy the situation. Being aware of the potential for a maternal heart rate recording, investigating the EFM signals, and correcting the monitoring can help prevent significant morbidity.

CASE 1 EFM shows seesaw decelerations and returns to baseline rate

A 29-year-old woman (G3P2) at 39 weeks’ gestation was admitted to the hospital with spontaneous labor. Continuous EFM external monitoring was initiated. After membranes spontaneously ruptured at 4 cm dilation, an epidural was placed. Throughout the active phase of labor, the fetus demonstrated intermittent mild variable decelerations, and the fetal heart rate baseline increased to 180 beats per minute (BPM). With complete dilation, the patient initiated pushing. During the first several pushes, the EFM demonstrated an initial heart rate deceleration, and a loss of signal, but the heart rate returned to a baseline rate of 150 BPM. With the patient’s continued pushing efforts, the EFM baseline increased to 180 BPM, with evidence of variable decelerations to a nadir of 120 BPM, although with some signal gaps (FIGURE 1, red arrow). The tracing then appeared to have a baseline of 120 BPM with variability or accelerations (FIGURE 1, green arrow) before shifting again to 170 to 180 BPM.

What was happening?

Why does the EFM record the maternal heart rate?

Most commonly, EFM recording of the maternal heart rate occurs during the second stage of labor. Early in labor, the normal fetal heart rate (110–160 BPM) typically exceeds the basal maternal heart rate. However, in the presence of chorioamnionitis and maternal fever or with the stress of maternal pushing, the maternal heart rate frequently approaches or exceeds that of the fetal heart rate. The maximum maternal heart rate can be estimated as 220 BPM minus the maternal age. Thus, the heart rate in a 20-year-old gravida may reach rates of 160 to 180 BPM, equivalent to 80% to 90% of her maximum heart rate during second-stage pushing.

The external Doppler fetal monitor, having a somewhat narrow acoustic window, may lose the focus on the fetal heart as a result of descent of the baby, the abdominal shape-altering effect of uterine contractions, and the patient’s pushing. During the second stage, the EFM may record the maternal heart rate from the uterine arteries. Although some clinicians claim to differentiate the maternal from the fetal heart rate by the “whooshing” maternal uterine artery signal as compared with the “thumping” fetal heart rate signal, this auditory assessment is unproven and likely unreliable.

CASE 1 Problem recognized and addressed

In this case, the obstetrician recognized that “slipping” from the fetal to the maternal heart rate recording occurred with the onset of maternal pushing. After the pushing ceased, the maternal heart rate slipped back to the fetal heart rate. With the next several contractions, only the maternal heart rate was recorded. A fetal scalp electrode was then placed, and fetal variable decelerations were recognized. In view of the category II EFM recording, a vacuum procedure was performed from +3 station and a female infant was delivered. She had Apgar scores of 6 and 8 at 1 and 5 minutes, respectively, and she did well in the nursery.

Read what happened in Case 2 when the EFM demonstrated breaks in the tracing

CASE 2 EFM tracings belie the clinical situation

A 20-year-old woman (G1P0) presented for induction of labor at 41 weeks’ gestation. Continuous EFM recording was initiated, and the patient was given dinoprostone and, subsequently, oxytocin. Rupture of membranes at 3 cm demonstrated a small amount of fluid with thick meconium. The patient progressed to complete dilation and developed a temperature of 38.5°C; the EFM baseline increased to 180 BPM. Throughout the first hour of the second stage of labor, the EFM demonstrated breaks in the tracing and a heart rate of 130 to 150 BPM with each pushing effort (FIGURE 2A). The Doppler monitor was subsequently adjusted to focus on the fetal heart and repetitive late decelerations were observed (FIGURE 2B). An emergent cesarean delivery was performed. A depressed newborn male was delivered, with Apgar scores of 2 and 4 at 1 and 5 minutes, respectively, and significant metabolic acidosis.

What happened?

Fetal versus maternal responses to pushing

The fetal variable deceleration pattern is well recognized by clinicians. As a result of umbilical cord occlusion (due to compression, stretching, or twisting of the cord), fetal variable decelerations have a typical pattern. An initial acceleration shoulder resulting from umbilical vein occlusion (due to reduced venous return) is followed by an umbilical artery occlusion–induced sharp deceleration. The relief of the occlusion allows the sharp return toward baseline with the secondary shoulder overshoot.

In some cases, partial umbilical cord occlusion that affects only the fetal umbilical vein may result in an acceleration, although these usually resolve or evolve into variable decelerations within 30 minutes. By contrast, the maternal heart rate typically increases with contractions and with maternal pushing efforts. Thus, a repetitive pattern of heart rate accelerations with each contraction should warn of a possible maternal heart rate recording.

How maternal heart rate responds to pushing. Maternal pushing is a Valsalva maneuver. Although there are 4 classic cardiovascular phases of Valsalva responses, the typical maternal pushing effort results in an increase in the maternal heart rate. With the common sequence of three 10-second pushes during each contraction, the maternal heart rate often exhibits 3 acceleration and deceleration responses. The maternal heart rate tracing looks similar to the shape of the Three Sisters mountain peaks in Oregon (FIGURE 3). Due to Valsalva physiology, the 3 peaks of the Sisters mirror the 3 uterine wave form peaks, although with a 5- to 10-second delay in the heart rate responses (mountain peaks) from the pushing efforts.

Pre- and postcontraction changes offer clues. Several classic findings aid in differentiating the maternal from the fetal heart rate. If the tracing is maternal, typically the heart rate gradually decreases following the end of the contraction/pushing and continues to decrease until the start of the next contraction/pushing, at which time it increases. During the push, the Three Sisters wave form, with the 5- to 10-second offset, should alert the clinician to possible maternal heart rate recordings. By contrast, the fetal heart rate variable deceleration typically increases following the end of the maternal contraction/pushing and is either stable or increases further (variable with slow recovery) prior to the next uterine contraction/pushing effort. These differences in the patterns of precontraction and postcontraction changes can be very valuable in differentiating periods of maternal versus fetal heart rate recordings.

With “slipping” between fetal and maternal recording, it is not uncommon to record fetal heart rate between contractions, slip to the maternal heart rate during the pushing effort, and return again to the fetal heart rate with the end of the contraction. When confounded with the potential for other EFM artifacts, including doubling of a low maternal or fetal heart rate, or halving of a tachycardic signal, it is not surprising that it is challenging to recognize an EFM maternal heart rate recording.

CASE 2 Check the monitor for accurate focus

A retrospective analysis of this case revealed that the maternal heart rate was recorded with each contraction throughout the second stage. The actual fetal heart rate pattern of decelerations was revealed with the refocusing of the Doppler monitor.

Read how subtle slipping manifested in the EFM tracing of Case 3

CASE 3 Low fetal heart rate and variability during contractions

A 22-year-old woman (G2P1) in spontaneous labor at term progressed to complete dilation. Fetal heart rate accelerations occurred for approximately 30 minutes. With the advent of pushing, the fetal heart rate showed a rate of 130 to 140 BPM and mild decelerations with each contraction (FIGURE 4A). As the second stage progressed, the tracing demonstrated an undulating baseline heart rate between 100 and 130 BPM with possible variability during contractions (FIGURE 4B). This pattern continued for an additional 60 minutes. At vaginal delivery, the ObGyn was surprised to deliver a depressed newborn with Apgar scores of 1 and 3 at 1 and 5 minutes, respectively.

Slipping from the fetal to the maternal heart rate may be imperceptible

In contrast to the breaks in the tracings seen in Case 1 and Case 2, the EFM tracing in Case 3 appears continuous. Yet, slipping from the fetal to the maternal recording was occurring.

As seen in FIGURE 4C, the maternal heart rate with variability was recorded during pushing efforts, and the fetal heart rate was seen rising back toward a baseline between contractions. Note that the fetal heart rate did not reach a level baseline, but rather decelerated with the next contraction. The slipping to the maternal heart rate occurred without a perceptible break in the recording, making this tracing extremely difficult to interpret.

CASE 3 Be ever vigilant

The lack of recognition that the EFM recording had slipped to the maternal heart rate resulted in fetal and newborn hypoxia and acidosis, accounting for the infant’s low Apgar scores.

Read how using 3 steps can help you distinguish fetal from maternal heart rate patterns

Follow 3 steps to discern fetal vs maternal heart rate

These cases illustrate the difficulties in recognizing maternal heart rate patterns on the fetal monitor tracing. The 3 simple steps described below can aid in differentiating maternal from fetal heart rate patterns.

1 Be aware and alert

Recognize that EFM monitoring of the maternal heart rate may occur during periods of monitoring, particularly in second-stage labor. Often, the recorded tracing is a mix of fetal and maternal patterns. Remember that the maternal heart rate may increase markedly during the second stage and rise even higher during pushing efforts. When presented with a tracing that ostensibly represents the fetus, it may be challenging for the clinician to question that assumption. Thus, be aware that tracings may not represent what they seem to be.

Often, clinicians view only the 10-minute portion of the tracing displayed on the monitor screen. I recommend, however, that clinicians review the tracing over the past 30 to 60 minutes, or since their last EFM assessment, for an understanding of the recent fetal baseline heart rate and decelerations.

2 Investigate

Although it is sometimes challenging to recognize EFM maternal heart rate recordings, this is relatively easy to investigate. Even without a pulse oximeter in place, carefully examine the EFM recording for maternal signs to determine if the maternal heart rate is within the range of the recording. You can confirm that the recording is maternal through 1 of 3 easy measures:

• First, check the maternal radial pulse and correlate it with the heart rate baseline.
• Second, place a maternal electrocardiographic (EKG) heart rate monitor.
• Last, and often the simplest approach for continuous tracings, place a finger pulse oximeter to provide a continuous maternal pulse reading. Should the maternal heart rate superimpose on the EFM recording, maternal patterns are likely being detected. However, since the pulse oximeter and EFM Doppler devices use different technologies, they will provide similar—but not precisely identical—heart rate numerical readings if both are assessing the maternal heart rate. In that case, take steps to assure that the EFM truly is recording the fetal heart rate.

3 Treat and correct

If the EFM is recording a maternal signal or if a significant question remains, place a fetal scalp electrode (unless contraindicated), as this may likely occur during the second stage. Alternatively, place a maternal surface fetal EKG monitor, or use ultrasonography to visually assess the fetal heart rate in real time.

Key point summary

The use of a maternal finger pulse oximeter, combined with a careful assessment of the EFM tracing, and/or a fetal scalp electrode are appropriate measures for confirming a fetal heart rate recording.

The 3 steps described (be aware and alert, investigate, treat and correct) can help you effectively monitor the fetal heart rate and avoid the potentially dangerous outcomes that might occur when the maternal heart rate masquerades as the fetal heart rate.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Continuous electronic fetal heart rate monitoring (EFM) is used in the vast majority of all labors in the United States. With the use of EFM categories and definitions from the American College of Obstetricians and Gynecologists, the National Institutes of Health, and the Society for Maternal-Fetal Medicine, clinicians can now better define and communicate tracing assessments. Except for reducing neonatal seizure activity, however, EFM use during labor has not been demonstrated to significantly improve fetal and neonatal outcomes, yet EFM is associated with an increase in cesarean deliveries and instrument-assisted vaginal births.¹

The negative predictive value of EFM for fetal hypoxia/acidosis is high, but its positive predictive value is only 30%, and the false-positive rate is as high as 60%.² Although a false-positive assessment may result in a potentially unnecessary operative vaginal or cesarean delivery, a falsely reassuring strip may produce devastating consequences in the newborn and, not infrequently, medical malpractice liability. One etiology associated with falsely reassuring assessments is that of EFM monitoring of the maternal heart rate and the failure to recognize the tracing as maternal.

In this article, I discuss the mechanisms and periods of labor that often are associated with the maternal heart rate masquerading as the fetal heart rate. I review common EFM patterns associated with the maternal heart rate so as to aid in recognizing the maternal heart rate. In addition, I provide 3 case scenarios that illustrate the simple yet critical steps that clinicians can take to remedy the situation. Being aware of the potential for a maternal heart rate recording, investigating the EFM signals, and correcting the monitoring can help prevent significant morbidity.

CASE 1 EFM shows seesaw decelerations and returns to baseline rate

A 29-year-old woman (G3P2) at 39 weeks’ gestation was admitted to the hospital with spontaneous labor. Continuous EFM external monitoring was initiated. After membranes spontaneously ruptured at 4 cm dilation, an epidural was placed. Throughout the active phase of labor, the fetus demonstrated intermittent mild variable decelerations, and the fetal heart rate baseline increased to 180 beats per minute (BPM). With complete dilation, the patient initiated pushing. During the first several pushes, the EFM demonstrated an initial heart rate deceleration, and a loss of signal, but the heart rate returned to a baseline rate of 150 BPM. With the patient’s continued pushing efforts, the EFM baseline increased to 180 BPM, with evidence of variable decelerations to a nadir of 120 BPM, although with some signal gaps (FIGURE 1, red arrow). The tracing then appeared to have a baseline of 120 BPM with variability or accelerations (FIGURE 1, green arrow) before shifting again to 170 to 180 BPM.

What was happening?

Why does the EFM record the maternal heart rate?

Most commonly, EFM recording of the maternal heart rate occurs during the second stage of labor. Early in labor, the normal fetal heart rate (110–160 BPM) typically exceeds the basal maternal heart rate. However, in the presence of chorioamnionitis and maternal fever or with the stress of maternal pushing, the maternal heart rate frequently approaches or exceeds that of the fetal heart rate. The maximum maternal heart rate can be estimated as 220 BPM minus the maternal age. Thus, the heart rate in a 20-year-old gravida may reach rates of 160 to 180 BPM, equivalent to 80% to 90% of her maximum heart rate during second-stage pushing.

The external Doppler fetal monitor, having a somewhat narrow acoustic window, may lose the focus on the fetal heart as a result of descent of the baby, the abdominal shape-altering effect of uterine contractions, and the patient’s pushing. During the second stage, the EFM may record the maternal heart rate from the uterine arteries. Although some clinicians claim to differentiate the maternal from the fetal heart rate by the “whooshing” maternal uterine artery signal as compared with the “thumping” fetal heart rate signal, this auditory assessment is unproven and likely unreliable.

CASE 1 Problem recognized and addressed

In this case, the obstetrician recognized that “slipping” from the fetal to the maternal heart rate recording occurred with the onset of maternal pushing. After the pushing ceased, the maternal heart rate slipped back to the fetal heart rate. With the next several contractions, only the maternal heart rate was recorded. A fetal scalp electrode was then placed, and fetal variable decelerations were recognized. In view of the category II EFM recording, a vacuum procedure was performed from +3 station and a female infant was delivered. She had Apgar scores of 6 and 8 at 1 and 5 minutes, respectively, and she did well in the nursery.

Read what happened in Case 2 when the EFM demonstrated breaks in the tracing

CASE 2 EFM tracings belie the clinical situation

A 20-year-old woman (G1P0) presented for induction of labor at 41 weeks’ gestation. Continuous EFM recording was initiated, and the patient was given dinoprostone and, subsequently, oxytocin. Rupture of membranes at 3 cm demonstrated a small amount of fluid with thick meconium. The patient progressed to complete dilation and developed a temperature of 38.5°C; the EFM baseline increased to 180 BPM. Throughout the first hour of the second stage of labor, the EFM demonstrated breaks in the tracing and a heart rate of 130 to 150 BPM with each pushing effort (FIGURE 2A). The Doppler monitor was subsequently adjusted to focus on the fetal heart and repetitive late decelerations were observed (FIGURE 2B). An emergent cesarean delivery was performed. A depressed newborn male was delivered, with Apgar scores of 2 and 4 at 1 and 5 minutes, respectively, and significant metabolic acidosis.

What happened?

Fetal versus maternal responses to pushing

The fetal variable deceleration pattern is well recognized by clinicians. As a result of umbilical cord occlusion (due to compression, stretching, or twisting of the cord), fetal variable decelerations have a typical pattern. An initial acceleration shoulder resulting from umbilical vein occlusion (due to reduced venous return) is followed by an umbilical artery occlusion–induced sharp deceleration. The relief of the occlusion allows the sharp return toward baseline with the secondary shoulder overshoot.

In some cases, partial umbilical cord occlusion that affects only the fetal umbilical vein may result in an acceleration, although these usually resolve or evolve into variable decelerations within 30 minutes. By contrast, the maternal heart rate typically increases with contractions and with maternal pushing efforts. Thus, a repetitive pattern of heart rate accelerations with each contraction should warn of a possible maternal heart rate recording.

How maternal heart rate responds to pushing. Maternal pushing is a Valsalva maneuver. Although there are 4 classic cardiovascular phases of Valsalva responses, the typical maternal pushing effort results in an increase in the maternal heart rate. With the common sequence of three 10-second pushes during each contraction, the maternal heart rate often exhibits 3 acceleration and deceleration responses. The maternal heart rate tracing looks similar to the shape of the Three Sisters mountain peaks in Oregon (FIGURE 3). Due to Valsalva physiology, the 3 peaks of the Sisters mirror the 3 uterine wave form peaks, although with a 5- to 10-second delay in the heart rate responses (mountain peaks) from the pushing efforts.

Pre- and postcontraction changes offer clues. Several classic findings aid in differentiating the maternal from the fetal heart rate. If the tracing is maternal, typically the heart rate gradually decreases following the end of the contraction/pushing and continues to decrease until the start of the next contraction/pushing, at which time it increases. During the push, the Three Sisters wave form, with the 5- to 10-second offset, should alert the clinician to possible maternal heart rate recordings. By contrast, the fetal heart rate variable deceleration typically increases following the end of the maternal contraction/pushing and is either stable or increases further (variable with slow recovery) prior to the next uterine contraction/pushing effort. These differences in the patterns of precontraction and postcontraction changes can be very valuable in differentiating periods of maternal versus fetal heart rate recordings.

With “slipping” between fetal and maternal recording, it is not uncommon to record fetal heart rate between contractions, slip to the maternal heart rate during the pushing effort, and return again to the fetal heart rate with the end of the contraction. When confounded with the potential for other EFM artifacts, including doubling of a low maternal or fetal heart rate, or halving of a tachycardic signal, it is not surprising that it is challenging to recognize an EFM maternal heart rate recording.

CASE 2 Check the monitor for accurate focus

A retrospective analysis of this case revealed that the maternal heart rate was recorded with each contraction throughout the second stage. The actual fetal heart rate pattern of decelerations was revealed with the refocusing of the Doppler monitor.

Read how subtle slipping manifested in the EFM tracing of Case 3

CASE 3 Low fetal heart rate and variability during contractions

A 22-year-old woman (G2P1) in spontaneous labor at term progressed to complete dilation. Fetal heart rate accelerations occurred for approximately 30 minutes. With the advent of pushing, the fetal heart rate showed a rate of 130 to 140 BPM and mild decelerations with each contraction (FIGURE 4A). As the second stage progressed, the tracing demonstrated an undulating baseline heart rate between 100 and 130 BPM with possible variability during contractions (FIGURE 4B). This pattern continued for an additional 60 minutes. At vaginal delivery, the ObGyn was surprised to deliver a depressed newborn with Apgar scores of 1 and 3 at 1 and 5 minutes, respectively.

Slipping from the fetal to the maternal heart rate may be imperceptible

In contrast to the breaks in the tracings seen in Case 1 and Case 2, the EFM tracing in Case 3 appears continuous. Yet, slipping from the fetal to the maternal recording was occurring.

As seen in FIGURE 4C, the maternal heart rate with variability was recorded during pushing efforts, and the fetal heart rate was seen rising back toward a baseline between contractions. Note that the fetal heart rate did not reach a level baseline, but rather decelerated with the next contraction. The slipping to the maternal heart rate occurred without a perceptible break in the recording, making this tracing extremely difficult to interpret.

CASE 3 Be ever vigilant

The lack of recognition that the EFM recording had slipped to the maternal heart rate resulted in fetal and newborn hypoxia and acidosis, accounting for the infant’s low Apgar scores.

Read how using 3 steps can help you distinguish fetal from maternal heart rate patterns

Follow 3 steps to discern fetal vs maternal heart rate

These cases illustrate the difficulties in recognizing maternal heart rate patterns on the fetal monitor tracing. The 3 simple steps described below can aid in differentiating maternal from fetal heart rate patterns.

1 Be aware and alert

Recognize that EFM monitoring of the maternal heart rate may occur during periods of monitoring, particularly in second-stage labor. Often, the recorded tracing is a mix of fetal and maternal patterns. Remember that the maternal heart rate may increase markedly during the second stage and rise even higher during pushing efforts. When presented with a tracing that ostensibly represents the fetus, it may be challenging for the clinician to question that assumption. Thus, be aware that tracings may not represent what they seem to be.

Often, clinicians view only the 10-minute portion of the tracing displayed on the monitor screen. I recommend, however, that clinicians review the tracing over the past 30 to 60 minutes, or since their last EFM assessment, for an understanding of the recent fetal baseline heart rate and decelerations.

2 Investigate

Although it is sometimes challenging to recognize EFM maternal heart rate recordings, this is relatively easy to investigate. Even without a pulse oximeter in place, carefully examine the EFM recording for maternal signs to determine if the maternal heart rate is within the range of the recording. You can confirm that the recording is maternal through 1 of 3 easy measures:

• First, check the maternal radial pulse and correlate it with the heart rate baseline.
• Second, place a maternal electrocardiographic (EKG) heart rate monitor.
• Last, and often the simplest approach for continuous tracings, place a finger pulse oximeter to provide a continuous maternal pulse reading. Should the maternal heart rate superimpose on the EFM recording, maternal patterns are likely being detected. However, since the pulse oximeter and EFM Doppler devices use different technologies, they will provide similar—but not precisely identical—heart rate numerical readings if both are assessing the maternal heart rate. In that case, take steps to assure that the EFM truly is recording the fetal heart rate.

3 Treat and correct

If the EFM is recording a maternal signal or if a significant question remains, place a fetal scalp electrode (unless contraindicated), as this may likely occur during the second stage. Alternatively, place a maternal surface fetal EKG monitor, or use ultrasonography to visually assess the fetal heart rate in real time.

Key point summary

The use of a maternal finger pulse oximeter, combined with a careful assessment of the EFM tracing, and/or a fetal scalp electrode are appropriate measures for confirming a fetal heart rate recording.

The 3 steps described (be aware and alert, investigate, treat and correct) can help you effectively monitor the fetal heart rate and avoid the potentially dangerous outcomes that might occur when the maternal heart rate masquerades as the fetal heart rate.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this Update I highlight 5 interesting investigations on infectious diseases. The first addresses the value of applying prophylactically a negative-pressure wound dressing to prevent surgical site infection (SSI) in obese women having cesarean delivery (CD). The second report assesses the effectiveness of a preoperative vaginal wash in reducing the frequency of postcesarean endometritis. The third investigation examines the role of systemic antibiotics, combined with surgical drainage, for patients who have subcutaneous abscesses ranging in size up to 5 cm. The fourth study presents new information about the major risk factors for Clostridium difficile infections in obstetric patients. The final study presents valuable sobering new data about the risks of congenital Zika virus infection.

Negative-pressure wound therapy after CD shows some benefit in preventing SSI

Yu L, Kronen RJ, Simon LE, Stoll CR, Colditz GA, Tuuli MG. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018;218(2):200-210.e1.

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

Yu and colleagues sought to determine if the prophylactic use of negative-pressure devices, compared with standard wound dressing, was effective in reducing the frequency of SSI after CD.

The authors searched multiple databases and initially identified 161 randomized controlled trials and cohort studies for further assessment. After applying rigorous exclusion criteria, they ultimately selected 9 studies for systematic review and meta-analysis. Six studies were randomized controlled trials (RCTs), 2 were retrospective cohort studies, and 1 was a prospective cohort study. Five studies were considered high quality; 4 were of low quality. 

Details of the study

Several types of negative-pressure devices were used, but the 2 most common were the Prevena incision management system (KCI, San Antonio, Texas) and PICO negative- pressure wound therapy (Smith & Nephew, St. Petersburg, Florida). The majority of patients in all groups were at high risk for wound complications because of obesity.

The primary outcome of interest was the frequency of SSI. Secondary outcomes included dehiscence, seroma, endometritis, a composite measure for all wound complications, and hospital readmission.

The absolute risk of SSI in the intervention group was 5% (95% confidence interval [CI], 2.0%-7.0%) compared with 11% (95% CI, 7.0%-16.0%) in the standard dressing group. The pooled risk ratio was 0.45 (95% CI, 0.31-0.66). The absolute risk reduction was 6% (95% CI, -10.0% to -3.0%), and the number needed to treat was 17.

There were no significant differences in the rate of any of the secondary outcomes other than the composite of all wound complications. This difference was largely accounted for by the difference in the rate of SSI. 

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

How negative-pressure devices aid wound healing

Yu and colleagues explained that negative-pressure devices exert their beneficial effects in various ways, including:

• shrinking the wound  
• inducing cellular stretch
• removing extracellular fluids
• creating a favorable environment for healing
• promoting angiogenesis and neurogenesis.

Multiple studies in nonobstetric patients have shown that prophylactic use of negative-pressure devices is beneficial in reducing the rate of SSI.¹ Yu and colleagues' systematic review and meta-analysis confirms those findings in a high-risk population of women having CD.

Study limitations

Before routinely adopting the use of negative-pressure devices for all women having CD, however, obstetricians should consider the following caveats:  

• The investigations included in the study by Yu and colleagues did not consistently distinguish between scheduled versus unscheduled CDs.
• The reports did not systematically consider other major risk factors for wound complications besides obesity, and they did not control for these confounders in the statistical analyses.
• The studies included in the meta-analysis did not provide full descriptions of other measures that might influence the rate of SSIs, such as timing and selection of prophylactic antibiotics, selection of suture material, preoperative skin preparation, and closure techniques for the deep subcutaneous tissue and skin.
• None of the included studies systematically considered the cost-effectiveness of the negative-pressure devices. This is an important consideration given that the acquisition cost of these devices ranges from $200 to $500.

Read about vaginal cleansing’s effect on post-CD endometritis

Vaginal cleansing before CD lowers risk of postop endometritis

Caissutti C, Saccone G, Zullo F, et al. Vaginal cleansing before cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2017;130(3):527-538.

Photo: Shutterstock

Caissutti and colleagues aimed to determine if cleansing the vagina with an antiseptic solution prior to surgery reduced the frequency of postcesarean endometritis. They included 16 RCTs (4,837 patients) in their systematic review and meta-analysis. The primary outcome was the frequency of postoperative endometritis.

Details of the study

The studies were conducted in several countries and included patients of various socioeconomic classes. Six trials included only patients having a scheduled CD; 9 included both scheduled and unscheduled cesareans; and 1 included only unscheduled cesareans. In 11 studies, povidone-iodine was the antiseptic solution used. Two trials used chlorhexidine diacetate 0.2%, and 1 used chlorhexidine diacetate 0.4%. One trial used metronidazole 0.5% gel, and another used the antiseptic cetrimide, which is a mixture of different quaternary ammonium salts, including cetrimonium bromide.

In all trials, patients received prophylactic antibiotics. The antibiotics were administered prior to the surgical incision in 6 trials; they were given after the umbilical cord was clamped in 6 trials. In 2 trials, the antibiotics were given at varying times, and in the final 2 trials, the timing of antibiotic administration was not reported. Of note, no trials described the method of placenta removal, a factor of considerable significance in influencing the rate of postoperative endometritis.^5,6

Endometritis frequency reduced with vaginal cleansing; benefit greater in certain groups. Overall, in the 15 trials in which vaginal cleansing was compared with placebo or with no treatment, women in the treatment group had a significantly lower rate of endometritis (4.5% compared with 8.8%; relative risk [RR], 0.52; 95% CI, 0.37-0.72). When only women in labor were considered, the frequency of endometritis was 8.1% in the intervention group compared with 13.8% in the control group (RR, 0.52; 95% CI, 0.28-0.97). In the women who were not in labor, the difference in the incidence of endometritis was not statistically significant (3.5% vs 6.6%; RR, 0.62; 95% CI, 0.34-1.15).

In the subgroup analysis of women with ruptured membranes at the time of surgery, the incidence of endometritis was 4.3% in the treatment group compared with 20.1% in the control group (RR, 0.23; 95% CI, 0.10-0.52). In women with intact membranes at the time of surgery, the incidence of endometritis was not significantly reduced in the treatment group.

Interestingly, in the subgroup analysis of the 10 trials that used povidone-iodine, the reduction in the frequency of postcesarean endometritis was statistically significant (2.8% vs 6.3%; RR, 0.42; 95% CI, 0.25-0.71). However, this same protective effect was not observed in the women treated with chlorhexidine. In the 1 trial that directly compared povidone-iodine with chlorhexidine, there was no statistically significant difference in outcome.

Simple intervention, solid benefit

Endometritis is the most common complication following CD. The infection is polymicrobial, with mixed aerobic and anaerobic organisms. The principal risk factors for postcesarean endometritis are low socioeconomic status, extended duration of labor and ruptured membranes, multiple vaginal examinations, internal fetal monitoring, and pre-existing vaginal infections (principally, bacterial vaginosis and group B streptococcal colonization).

Two interventions are clearly of value in reducing the incidence of endometritis: administration of prophylactic antibiotics prior to the surgical incision and removal of the placenta by traction on the cord as opposed to manual extraction.^5,6

The assessment by Caissutti and colleagues confirms that a third measure — preoperative vaginal cleansing — also helps reduce the incidence of postcesarean endometritis. The principal benefit is seen in women who have been in labor with ruptured membranes, although certainly it is not harmful in lower-risk patients. The intervention is simple and straightforward: a 30-second vaginal wash with a povidone-iodine solution just prior to surgery.

Read about management approaches for skin abscesses

Treat smaller skin abscesses with antibiotics after surgical drainage? Yes.

Daum RS, Miller LG, Immergluck L, et al; for the DMID 07-0051 Team. A placebo-controlled trial of antibiotics for smaller skin abscesses. N Engl J Med. 2017;376(26):2545-2555.

Photo: Shutterstock

For treatment of subcutaneous abscesses that were 5 cm or smaller in diameter, investigators sought to determine if surgical drainage alone was equivalent to surgical drainage plus systemic antibiotics. After their abscess was drained, patients were randomly assigned to receive either clindamycin (300 mg 3 times daily) or trimethoprim-sulfamethoxazole (80 mg/400 mg twice daily) or placebo for 10 days. The primary outcome was clinical cure 7 to 10 days after treatment.

Details of the study

Daum and colleagues enrolled 786 participants (505 adults, 281 children) in the prospective double-blind study. Staphylococcus aureus was isolated from 527 patients (67.0%); methicillin-resistant S aureus (MRSA) was isolated from 388 (49.4%). The cure rate was similar in patients in the clindamycin group (83.1%) and the trimethoprim-sulfamethoxazole group (81.7%), and the cure rate in each antibiotic group was significantly higher than that in the placebo group (68.9%; P<.001 for both comparisons). The difference in treatment effect was specifically limited to patients who had S aureus isolated from their lesions.

Findings at follow-up. At 1 month of  follow-up, new infections were less common in the clindamycin group (6.8%) than in the trimethoprim-sulfamethoxazole group (13.5%; P = .03) or the placebo group (12.4%; P = .06). However, the highest frequency of adverse effects occurred in the patients who received clindamycin (21.9% vs 11.1% vs 12.5%). No adverse effects were judged to be serious, and all resolved without sequela.

Controversy remains on antibiotic use after drainage

This study is important for 2 major reasons. First, soft tissue infections are quite commonand can evolve into serious problems, especially when the offending pathogen is MRSA. Second, controversy exists about whether systemic antibiotics are indicated if the subcutaneous abscess is relatively small and is adequately drained. For example, Talan and colleagues demonstrated that, in settings with a high prevalence of MRSA, surgical drainage combined with trimethoprim-sulfamethoxazole (1 double-strength tablet orally twice daily) was superior to drainage plus placebo.⁸ However, Daum and Gold recently debated the issue of drainage plus antibiotics in a case vignette and reached opposite conclusions.⁹

Read how to avoid C difficile infections in pregnant patients

Antibiotic use, common in the obstetric population, raises risk for C difficile infection

Ruiter-Ligeti J, Vincent S, Czuzoj-Shulman N, Abenhaim HA. Risk factors, incidence, and morbidity associated with obstetric Clostridium difficile infection. Obstet Gynecol. 2018;131(2):387-391.

Photo: Shutterstock

The objective of this investigation was to identify risk factors for Clostridium difficile infection (previously termed pseudomembranous enterocolitis) in obstetric patients. The authors performed a retrospective cohort study using information from a large database maintained by the Agency for Healthcare Research and Quality. This database provides information about inpatient hospital stays in the United States, and it is the largest repository of its kind. It includes data from a sample of 1,000 US hospitals.

Details of the study

Ruiter-Ligeti and colleagues reviewed 13,881,592 births during 1999-2013 and identified 2,757 (0.02%) admissions for delivery complicated by C difficile infection, a rate of 20 admissions per 100,000 deliveries per year (95% CI, 19.13-20.62). The rate of admissions with this diagnosis doubled from 1999 (15 per 100,000) to 2013 (30 per 100,000, P<.001).

Among these obstetric patients, the principal risk factors for C difficile infection were older age, multiple gestation, long-term antibiotic use (not precisely defined), and concurrent diagnosis of inflammatory bowel disease. In addition, patients with pyelonephritis, perineal or cesarean wound infections, or pneumonia also were at increased risk, presumably because those patients required longer courses of broad-spectrum antibiotics.

Of additional note, when compared with women who did not have C difficile infection, patients with infection were more likely to develop a thromboembolic event (38.4 per 1,000), paralytic ileus (58.0 per 1,000), sepsis (46.4 per 1,000), and death (8.0 per 1,000).

Be on guard for C difficile infection in antibiotic-treated obstetric patients

C difficile infection is an uncommon but potentially very serious complication of antibiotic therapy. Given that approximately half of all women admitted for delivery are exposed to antibiotics because of prophylaxis for group B streptococcus infection, prophylaxis for CD, and treatment of chorioamnionitis and puerperal endometritis, clinicians constantly need to be vigilant for this complication.¹¹

Affected patients typically present with frequent loose, watery stools and lower abdominal cramping. In severe cases, blood may be present in the stool, and signs of intestinal distention and even acute peritonitis may be evident. The diagnosis can be established by documenting a positive culture or polymerase chain reaction (PCR) assay for C difficile and a positive cytotoxin assay for toxins A and/or B. In addition, if endoscopy is performed, the characteristic gray membranous plaques can be visualized on the rectal and colonic mucosa.¹¹

Discontinue antibiotic therapy. The first step in managing affected patients is to stop all antibiotics, if possible, or at least the one most likely to be the causative agent of C difficile infection. Patients with relatively mild clinical findings should be treated with oral metronidazole, 500 mg every 8 hours for 10 to 14 days. Patients with severe findings should be treated with oral vancomycin, 500 mg every 6 hours, plus IV metronidazole, 500 mg every 8 hours. The more seriously ill patient must be observed carefully for signs of bowel obstruction, intestinal perforation, peritonitis, and sepsis.

Read about pregnancy outcomes and trimester of maternal Zika infection

Danger for birth defects with maternal Zika infection present in all trimesters, but greatest in first

Hoen B, Schaub B, Funk AL, et al. Pregnancy outcomes after ZIKV infection in French territories in the Americas. N Engl J Med. 2018;378(11):985-994.

Photo: Shutterstock

To estimate the risk of congenital neurologic defects associated with Zika virus infection, Hoen and colleagues conducted a prospective cohort study of pregnant women with symptomatic Zika virus infection who were enrolled during March through November 2016 in French Guiana, Guadeloupe, and Martinique. All women had Zika virus infection confirmed by PCR assay.

Details of the study

The investigators reviewed 546 pregnancies, which resulted in the birth of 555 fetuses and infants. Thirty-nine fetuses and neonates (7%; 95% CI, 5.0-9.5) had neurologic and ocular findings known to be associated with Zika virus infection. Of these, 10 pregnancies were terminated, 1 fetus was stillborn, and 28 were live-born.

Microcephaly (defined as head circumference more than 2 SD below the mean) was present in 32 fetuses and infants (5.8%); 9 had severe microcephaly, defined as head circumference more than 3 SD below the mean. Neurologic and ocular abnormalities were more common when maternal infection occurred during the first trimester (24 of 189 fetuses and infants, 12.7%) compared with infection during the second trimester (9 of 252, 3.6%) or third trimester (6 of 114, 5.3%) (P = .001). 

Studies report similar rates of fetal injury

Zika virus infection primarily is caused by a bite from the Aedes aegypti mosquito. The infection also can be transmitted by sexual contact, laboratory accident, and blood transfusion. Eighty percent of infected persons are asymptomatic. In symptomatic patients, the most common clinical manifestations are low-grade fever, a disseminated maculopapular rash, arthralgias, swelling of the hands and feet, and nonpurulent conjunctivitis.

The most ominous manifestation of congenital Zika virus infection is microcephaly. Other important manifestations include lissencephaly, pachygyria, cortical atrophy, ventriculomegaly, subcortical calcifications, ocular abnormalities, and arthrogryposis. Although most of these abnormalities are immediately visible in the neonate, some may not appear until the child is older.

The present study is an excellent complement to 2 recent reports that defined the risk of Zika virus-related fetal injury in patients in the United States and its territories. Based on an analysis of data from the US Zika Pregnancy Registry, Honein and colleagues reported an overall rate of congenital infection of 6%.¹² The rate of fetal injury was 11% when the mother was infected in the first trimester and 0% when the infection occurred in the second or third trimester. The overall rate of infection and the first trimester rate of infection were similar to those reported by Hoen and colleagues.

Conversely, Shapiro-Mendoza and colleagues evaluated rates of infection in US territories (American Samoa, Puerto Rico, and the US Virgin Islands) and observed cases of fetal injury associated with second- and third-trimester maternal infection.¹³ These authors reported an overall rate of infection of 5% and an 8% rate of infection with first-trimester maternal infection. When maternal infection occurred in the second and third trimesters, the rates of fetal injury were 5% and 4%, respectively, figures almost identical to those reported by Hoen and colleagues. Of note, the investigations by Honein and Shapiro-Mendoza included women with both symptomatic and asymptomatic infection. 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this Update I highlight 5 interesting investigations on infectious diseases. The first addresses the value of applying prophylactically a negative-pressure wound dressing to prevent surgical site infection (SSI) in obese women having cesarean delivery (CD). The second report assesses the effectiveness of a preoperative vaginal wash in reducing the frequency of postcesarean endometritis. The third investigation examines the role of systemic antibiotics, combined with surgical drainage, for patients who have subcutaneous abscesses ranging in size up to 5 cm. The fourth study presents new information about the major risk factors for Clostridium difficile infections in obstetric patients. The final study presents valuable sobering new data about the risks of congenital Zika virus infection.

Negative-pressure wound therapy after CD shows some benefit in preventing SSI

Yu L, Kronen RJ, Simon LE, Stoll CR, Colditz GA, Tuuli MG. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018;218(2):200-210.e1.

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

Yu and colleagues sought to determine if the prophylactic use of negative-pressure devices, compared with standard wound dressing, was effective in reducing the frequency of SSI after CD.

The authors searched multiple databases and initially identified 161 randomized controlled trials and cohort studies for further assessment. After applying rigorous exclusion criteria, they ultimately selected 9 studies for systematic review and meta-analysis. Six studies were randomized controlled trials (RCTs), 2 were retrospective cohort studies, and 1 was a prospective cohort study. Five studies were considered high quality; 4 were of low quality. 

Details of the study

Several types of negative-pressure devices were used, but the 2 most common were the Prevena incision management system (KCI, San Antonio, Texas) and PICO negative- pressure wound therapy (Smith & Nephew, St. Petersburg, Florida). The majority of patients in all groups were at high risk for wound complications because of obesity.

The primary outcome of interest was the frequency of SSI. Secondary outcomes included dehiscence, seroma, endometritis, a composite measure for all wound complications, and hospital readmission.

The absolute risk of SSI in the intervention group was 5% (95% confidence interval [CI], 2.0%-7.0%) compared with 11% (95% CI, 7.0%-16.0%) in the standard dressing group. The pooled risk ratio was 0.45 (95% CI, 0.31-0.66). The absolute risk reduction was 6% (95% CI, -10.0% to -3.0%), and the number needed to treat was 17.

There were no significant differences in the rate of any of the secondary outcomes other than the composite of all wound complications. This difference was largely accounted for by the difference in the rate of SSI. 

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

How negative-pressure devices aid wound healing

Yu and colleagues explained that negative-pressure devices exert their beneficial effects in various ways, including:

• shrinking the wound  
• inducing cellular stretch
• removing extracellular fluids
• creating a favorable environment for healing
• promoting angiogenesis and neurogenesis.

Multiple studies in nonobstetric patients have shown that prophylactic use of negative-pressure devices is beneficial in reducing the rate of SSI.¹ Yu and colleagues' systematic review and meta-analysis confirms those findings in a high-risk population of women having CD.

Study limitations

Before routinely adopting the use of negative-pressure devices for all women having CD, however, obstetricians should consider the following caveats:  

• The investigations included in the study by Yu and colleagues did not consistently distinguish between scheduled versus unscheduled CDs.
• The reports did not systematically consider other major risk factors for wound complications besides obesity, and they did not control for these confounders in the statistical analyses.
• The studies included in the meta-analysis did not provide full descriptions of other measures that might influence the rate of SSIs, such as timing and selection of prophylactic antibiotics, selection of suture material, preoperative skin preparation, and closure techniques for the deep subcutaneous tissue and skin.
• None of the included studies systematically considered the cost-effectiveness of the negative-pressure devices. This is an important consideration given that the acquisition cost of these devices ranges from $200 to $500.

Read about vaginal cleansing’s effect on post-CD endometritis

Vaginal cleansing before CD lowers risk of postop endometritis

Caissutti C, Saccone G, Zullo F, et al. Vaginal cleansing before cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2017;130(3):527-538.

Photo: Shutterstock

Caissutti and colleagues aimed to determine if cleansing the vagina with an antiseptic solution prior to surgery reduced the frequency of postcesarean endometritis. They included 16 RCTs (4,837 patients) in their systematic review and meta-analysis. The primary outcome was the frequency of postoperative endometritis.

Details of the study

The studies were conducted in several countries and included patients of various socioeconomic classes. Six trials included only patients having a scheduled CD; 9 included both scheduled and unscheduled cesareans; and 1 included only unscheduled cesareans. In 11 studies, povidone-iodine was the antiseptic solution used. Two trials used chlorhexidine diacetate 0.2%, and 1 used chlorhexidine diacetate 0.4%. One trial used metronidazole 0.5% gel, and another used the antiseptic cetrimide, which is a mixture of different quaternary ammonium salts, including cetrimonium bromide.

In all trials, patients received prophylactic antibiotics. The antibiotics were administered prior to the surgical incision in 6 trials; they were given after the umbilical cord was clamped in 6 trials. In 2 trials, the antibiotics were given at varying times, and in the final 2 trials, the timing of antibiotic administration was not reported. Of note, no trials described the method of placenta removal, a factor of considerable significance in influencing the rate of postoperative endometritis.^5,6

Endometritis frequency reduced with vaginal cleansing; benefit greater in certain groups. Overall, in the 15 trials in which vaginal cleansing was compared with placebo or with no treatment, women in the treatment group had a significantly lower rate of endometritis (4.5% compared with 8.8%; relative risk [RR], 0.52; 95% CI, 0.37-0.72). When only women in labor were considered, the frequency of endometritis was 8.1% in the intervention group compared with 13.8% in the control group (RR, 0.52; 95% CI, 0.28-0.97). In the women who were not in labor, the difference in the incidence of endometritis was not statistically significant (3.5% vs 6.6%; RR, 0.62; 95% CI, 0.34-1.15).

In the subgroup analysis of women with ruptured membranes at the time of surgery, the incidence of endometritis was 4.3% in the treatment group compared with 20.1% in the control group (RR, 0.23; 95% CI, 0.10-0.52). In women with intact membranes at the time of surgery, the incidence of endometritis was not significantly reduced in the treatment group.

Interestingly, in the subgroup analysis of the 10 trials that used povidone-iodine, the reduction in the frequency of postcesarean endometritis was statistically significant (2.8% vs 6.3%; RR, 0.42; 95% CI, 0.25-0.71). However, this same protective effect was not observed in the women treated with chlorhexidine. In the 1 trial that directly compared povidone-iodine with chlorhexidine, there was no statistically significant difference in outcome.

Simple intervention, solid benefit

Endometritis is the most common complication following CD. The infection is polymicrobial, with mixed aerobic and anaerobic organisms. The principal risk factors for postcesarean endometritis are low socioeconomic status, extended duration of labor and ruptured membranes, multiple vaginal examinations, internal fetal monitoring, and pre-existing vaginal infections (principally, bacterial vaginosis and group B streptococcal colonization).

Two interventions are clearly of value in reducing the incidence of endometritis: administration of prophylactic antibiotics prior to the surgical incision and removal of the placenta by traction on the cord as opposed to manual extraction.^5,6

The assessment by Caissutti and colleagues confirms that a third measure — preoperative vaginal cleansing — also helps reduce the incidence of postcesarean endometritis. The principal benefit is seen in women who have been in labor with ruptured membranes, although certainly it is not harmful in lower-risk patients. The intervention is simple and straightforward: a 30-second vaginal wash with a povidone-iodine solution just prior to surgery.

Read about management approaches for skin abscesses

Treat smaller skin abscesses with antibiotics after surgical drainage? Yes.

Daum RS, Miller LG, Immergluck L, et al; for the DMID 07-0051 Team. A placebo-controlled trial of antibiotics for smaller skin abscesses. N Engl J Med. 2017;376(26):2545-2555.

Photo: Shutterstock

For treatment of subcutaneous abscesses that were 5 cm or smaller in diameter, investigators sought to determine if surgical drainage alone was equivalent to surgical drainage plus systemic antibiotics. After their abscess was drained, patients were randomly assigned to receive either clindamycin (300 mg 3 times daily) or trimethoprim-sulfamethoxazole (80 mg/400 mg twice daily) or placebo for 10 days. The primary outcome was clinical cure 7 to 10 days after treatment.

Details of the study

Daum and colleagues enrolled 786 participants (505 adults, 281 children) in the prospective double-blind study. Staphylococcus aureus was isolated from 527 patients (67.0%); methicillin-resistant S aureus (MRSA) was isolated from 388 (49.4%). The cure rate was similar in patients in the clindamycin group (83.1%) and the trimethoprim-sulfamethoxazole group (81.7%), and the cure rate in each antibiotic group was significantly higher than that in the placebo group (68.9%; P<.001 for both comparisons). The difference in treatment effect was specifically limited to patients who had S aureus isolated from their lesions.

Findings at follow-up. At 1 month of  follow-up, new infections were less common in the clindamycin group (6.8%) than in the trimethoprim-sulfamethoxazole group (13.5%; P = .03) or the placebo group (12.4%; P = .06). However, the highest frequency of adverse effects occurred in the patients who received clindamycin (21.9% vs 11.1% vs 12.5%). No adverse effects were judged to be serious, and all resolved without sequela.

Controversy remains on antibiotic use after drainage

This study is important for 2 major reasons. First, soft tissue infections are quite commonand can evolve into serious problems, especially when the offending pathogen is MRSA. Second, controversy exists about whether systemic antibiotics are indicated if the subcutaneous abscess is relatively small and is adequately drained. For example, Talan and colleagues demonstrated that, in settings with a high prevalence of MRSA, surgical drainage combined with trimethoprim-sulfamethoxazole (1 double-strength tablet orally twice daily) was superior to drainage plus placebo.⁸ However, Daum and Gold recently debated the issue of drainage plus antibiotics in a case vignette and reached opposite conclusions.⁹

Read how to avoid C difficile infections in pregnant patients

Antibiotic use, common in the obstetric population, raises risk for C difficile infection

Ruiter-Ligeti J, Vincent S, Czuzoj-Shulman N, Abenhaim HA. Risk factors, incidence, and morbidity associated with obstetric Clostridium difficile infection. Obstet Gynecol. 2018;131(2):387-391.

Photo: Shutterstock

The objective of this investigation was to identify risk factors for Clostridium difficile infection (previously termed pseudomembranous enterocolitis) in obstetric patients. The authors performed a retrospective cohort study using information from a large database maintained by the Agency for Healthcare Research and Quality. This database provides information about inpatient hospital stays in the United States, and it is the largest repository of its kind. It includes data from a sample of 1,000 US hospitals.

Details of the study

Ruiter-Ligeti and colleagues reviewed 13,881,592 births during 1999-2013 and identified 2,757 (0.02%) admissions for delivery complicated by C difficile infection, a rate of 20 admissions per 100,000 deliveries per year (95% CI, 19.13-20.62). The rate of admissions with this diagnosis doubled from 1999 (15 per 100,000) to 2013 (30 per 100,000, P<.001).

Among these obstetric patients, the principal risk factors for C difficile infection were older age, multiple gestation, long-term antibiotic use (not precisely defined), and concurrent diagnosis of inflammatory bowel disease. In addition, patients with pyelonephritis, perineal or cesarean wound infections, or pneumonia also were at increased risk, presumably because those patients required longer courses of broad-spectrum antibiotics.

Of additional note, when compared with women who did not have C difficile infection, patients with infection were more likely to develop a thromboembolic event (38.4 per 1,000), paralytic ileus (58.0 per 1,000), sepsis (46.4 per 1,000), and death (8.0 per 1,000).

Be on guard for C difficile infection in antibiotic-treated obstetric patients

C difficile infection is an uncommon but potentially very serious complication of antibiotic therapy. Given that approximately half of all women admitted for delivery are exposed to antibiotics because of prophylaxis for group B streptococcus infection, prophylaxis for CD, and treatment of chorioamnionitis and puerperal endometritis, clinicians constantly need to be vigilant for this complication.¹¹

Affected patients typically present with frequent loose, watery stools and lower abdominal cramping. In severe cases, blood may be present in the stool, and signs of intestinal distention and even acute peritonitis may be evident. The diagnosis can be established by documenting a positive culture or polymerase chain reaction (PCR) assay for C difficile and a positive cytotoxin assay for toxins A and/or B. In addition, if endoscopy is performed, the characteristic gray membranous plaques can be visualized on the rectal and colonic mucosa.¹¹

Discontinue antibiotic therapy. The first step in managing affected patients is to stop all antibiotics, if possible, or at least the one most likely to be the causative agent of C difficile infection. Patients with relatively mild clinical findings should be treated with oral metronidazole, 500 mg every 8 hours for 10 to 14 days. Patients with severe findings should be treated with oral vancomycin, 500 mg every 6 hours, plus IV metronidazole, 500 mg every 8 hours. The more seriously ill patient must be observed carefully for signs of bowel obstruction, intestinal perforation, peritonitis, and sepsis.

Read about pregnancy outcomes and trimester of maternal Zika infection

Danger for birth defects with maternal Zika infection present in all trimesters, but greatest in first

Hoen B, Schaub B, Funk AL, et al. Pregnancy outcomes after ZIKV infection in French territories in the Americas. N Engl J Med. 2018;378(11):985-994.

Photo: Shutterstock

To estimate the risk of congenital neurologic defects associated with Zika virus infection, Hoen and colleagues conducted a prospective cohort study of pregnant women with symptomatic Zika virus infection who were enrolled during March through November 2016 in French Guiana, Guadeloupe, and Martinique. All women had Zika virus infection confirmed by PCR assay.

Details of the study

The investigators reviewed 546 pregnancies, which resulted in the birth of 555 fetuses and infants. Thirty-nine fetuses and neonates (7%; 95% CI, 5.0-9.5) had neurologic and ocular findings known to be associated with Zika virus infection. Of these, 10 pregnancies were terminated, 1 fetus was stillborn, and 28 were live-born.

Microcephaly (defined as head circumference more than 2 SD below the mean) was present in 32 fetuses and infants (5.8%); 9 had severe microcephaly, defined as head circumference more than 3 SD below the mean. Neurologic and ocular abnormalities were more common when maternal infection occurred during the first trimester (24 of 189 fetuses and infants, 12.7%) compared with infection during the second trimester (9 of 252, 3.6%) or third trimester (6 of 114, 5.3%) (P = .001). 

Studies report similar rates of fetal injury

Zika virus infection primarily is caused by a bite from the Aedes aegypti mosquito. The infection also can be transmitted by sexual contact, laboratory accident, and blood transfusion. Eighty percent of infected persons are asymptomatic. In symptomatic patients, the most common clinical manifestations are low-grade fever, a disseminated maculopapular rash, arthralgias, swelling of the hands and feet, and nonpurulent conjunctivitis.

The most ominous manifestation of congenital Zika virus infection is microcephaly. Other important manifestations include lissencephaly, pachygyria, cortical atrophy, ventriculomegaly, subcortical calcifications, ocular abnormalities, and arthrogryposis. Although most of these abnormalities are immediately visible in the neonate, some may not appear until the child is older.

The present study is an excellent complement to 2 recent reports that defined the risk of Zika virus-related fetal injury in patients in the United States and its territories. Based on an analysis of data from the US Zika Pregnancy Registry, Honein and colleagues reported an overall rate of congenital infection of 6%.¹² The rate of fetal injury was 11% when the mother was infected in the first trimester and 0% when the infection occurred in the second or third trimester. The overall rate of infection and the first trimester rate of infection were similar to those reported by Hoen and colleagues.

Conversely, Shapiro-Mendoza and colleagues evaluated rates of infection in US territories (American Samoa, Puerto Rico, and the US Virgin Islands) and observed cases of fetal injury associated with second- and third-trimester maternal infection.¹³ These authors reported an overall rate of infection of 5% and an 8% rate of infection with first-trimester maternal infection. When maternal infection occurred in the second and third trimesters, the rates of fetal injury were 5% and 4%, respectively, figures almost identical to those reported by Hoen and colleagues. Of note, the investigations by Honein and Shapiro-Mendoza included women with both symptomatic and asymptomatic infection. 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In this Update I highlight 5 interesting investigations on infectious diseases. The first addresses the value of applying prophylactically a negative-pressure wound dressing to prevent surgical site infection (SSI) in obese women having cesarean delivery (CD). The second report assesses the effectiveness of a preoperative vaginal wash in reducing the frequency of postcesarean endometritis. The third investigation examines the role of systemic antibiotics, combined with surgical drainage, for patients who have subcutaneous abscesses ranging in size up to 5 cm. The fourth study presents new information about the major risk factors for Clostridium difficile infections in obstetric patients. The final study presents valuable sobering new data about the risks of congenital Zika virus infection.

Negative-pressure wound therapy after CD shows some benefit in preventing SSI

Yu L, Kronen RJ, Simon LE, Stoll CR, Colditz GA, Tuuli MG. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018;218(2):200-210.e1.

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

Yu and colleagues sought to determine if the prophylactic use of negative-pressure devices, compared with standard wound dressing, was effective in reducing the frequency of SSI after CD.

The authors searched multiple databases and initially identified 161 randomized controlled trials and cohort studies for further assessment. After applying rigorous exclusion criteria, they ultimately selected 9 studies for systematic review and meta-analysis. Six studies were randomized controlled trials (RCTs), 2 were retrospective cohort studies, and 1 was a prospective cohort study. Five studies were considered high quality; 4 were of low quality. 

Details of the study

Several types of negative-pressure devices were used, but the 2 most common were the Prevena incision management system (KCI, San Antonio, Texas) and PICO negative- pressure wound therapy (Smith & Nephew, St. Petersburg, Florida). The majority of patients in all groups were at high risk for wound complications because of obesity.

The primary outcome of interest was the frequency of SSI. Secondary outcomes included dehiscence, seroma, endometritis, a composite measure for all wound complications, and hospital readmission.

The absolute risk of SSI in the intervention group was 5% (95% confidence interval [CI], 2.0%-7.0%) compared with 11% (95% CI, 7.0%-16.0%) in the standard dressing group. The pooled risk ratio was 0.45 (95% CI, 0.31-0.66). The absolute risk reduction was 6% (95% CI, -10.0% to -3.0%), and the number needed to treat was 17.

There were no significant differences in the rate of any of the secondary outcomes other than the composite of all wound complications. This difference was largely accounted for by the difference in the rate of SSI. 

Illustration: Used with permission. Courtesy of KCI, an Acelity Company

How negative-pressure devices aid wound healing

Yu and colleagues explained that negative-pressure devices exert their beneficial effects in various ways, including:

• shrinking the wound  
• inducing cellular stretch
• removing extracellular fluids
• creating a favorable environment for healing
• promoting angiogenesis and neurogenesis.

Multiple studies in nonobstetric patients have shown that prophylactic use of negative-pressure devices is beneficial in reducing the rate of SSI.¹ Yu and colleagues' systematic review and meta-analysis confirms those findings in a high-risk population of women having CD.

Study limitations

Before routinely adopting the use of negative-pressure devices for all women having CD, however, obstetricians should consider the following caveats:  

• The investigations included in the study by Yu and colleagues did not consistently distinguish between scheduled versus unscheduled CDs.
• The reports did not systematically consider other major risk factors for wound complications besides obesity, and they did not control for these confounders in the statistical analyses.
• The studies included in the meta-analysis did not provide full descriptions of other measures that might influence the rate of SSIs, such as timing and selection of prophylactic antibiotics, selection of suture material, preoperative skin preparation, and closure techniques for the deep subcutaneous tissue and skin.
• None of the included studies systematically considered the cost-effectiveness of the negative-pressure devices. This is an important consideration given that the acquisition cost of these devices ranges from $200 to $500.

Read about vaginal cleansing’s effect on post-CD endometritis

Vaginal cleansing before CD lowers risk of postop endometritis

Caissutti C, Saccone G, Zullo F, et al. Vaginal cleansing before cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2017;130(3):527-538.

Photo: Shutterstock

Caissutti and colleagues aimed to determine if cleansing the vagina with an antiseptic solution prior to surgery reduced the frequency of postcesarean endometritis. They included 16 RCTs (4,837 patients) in their systematic review and meta-analysis. The primary outcome was the frequency of postoperative endometritis.

Details of the study

The studies were conducted in several countries and included patients of various socioeconomic classes. Six trials included only patients having a scheduled CD; 9 included both scheduled and unscheduled cesareans; and 1 included only unscheduled cesareans. In 11 studies, povidone-iodine was the antiseptic solution used. Two trials used chlorhexidine diacetate 0.2%, and 1 used chlorhexidine diacetate 0.4%. One trial used metronidazole 0.5% gel, and another used the antiseptic cetrimide, which is a mixture of different quaternary ammonium salts, including cetrimonium bromide.

In all trials, patients received prophylactic antibiotics. The antibiotics were administered prior to the surgical incision in 6 trials; they were given after the umbilical cord was clamped in 6 trials. In 2 trials, the antibiotics were given at varying times, and in the final 2 trials, the timing of antibiotic administration was not reported. Of note, no trials described the method of placenta removal, a factor of considerable significance in influencing the rate of postoperative endometritis.^5,6

Endometritis frequency reduced with vaginal cleansing; benefit greater in certain groups. Overall, in the 15 trials in which vaginal cleansing was compared with placebo or with no treatment, women in the treatment group had a significantly lower rate of endometritis (4.5% compared with 8.8%; relative risk [RR], 0.52; 95% CI, 0.37-0.72). When only women in labor were considered, the frequency of endometritis was 8.1% in the intervention group compared with 13.8% in the control group (RR, 0.52; 95% CI, 0.28-0.97). In the women who were not in labor, the difference in the incidence of endometritis was not statistically significant (3.5% vs 6.6%; RR, 0.62; 95% CI, 0.34-1.15).

In the subgroup analysis of women with ruptured membranes at the time of surgery, the incidence of endometritis was 4.3% in the treatment group compared with 20.1% in the control group (RR, 0.23; 95% CI, 0.10-0.52). In women with intact membranes at the time of surgery, the incidence of endometritis was not significantly reduced in the treatment group.

Interestingly, in the subgroup analysis of the 10 trials that used povidone-iodine, the reduction in the frequency of postcesarean endometritis was statistically significant (2.8% vs 6.3%; RR, 0.42; 95% CI, 0.25-0.71). However, this same protective effect was not observed in the women treated with chlorhexidine. In the 1 trial that directly compared povidone-iodine with chlorhexidine, there was no statistically significant difference in outcome.

Simple intervention, solid benefit

Endometritis is the most common complication following CD. The infection is polymicrobial, with mixed aerobic and anaerobic organisms. The principal risk factors for postcesarean endometritis are low socioeconomic status, extended duration of labor and ruptured membranes, multiple vaginal examinations, internal fetal monitoring, and pre-existing vaginal infections (principally, bacterial vaginosis and group B streptococcal colonization).

Two interventions are clearly of value in reducing the incidence of endometritis: administration of prophylactic antibiotics prior to the surgical incision and removal of the placenta by traction on the cord as opposed to manual extraction.^5,6

The assessment by Caissutti and colleagues confirms that a third measure — preoperative vaginal cleansing — also helps reduce the incidence of postcesarean endometritis. The principal benefit is seen in women who have been in labor with ruptured membranes, although certainly it is not harmful in lower-risk patients. The intervention is simple and straightforward: a 30-second vaginal wash with a povidone-iodine solution just prior to surgery.

Read about management approaches for skin abscesses

Treat smaller skin abscesses with antibiotics after surgical drainage? Yes.

Daum RS, Miller LG, Immergluck L, et al; for the DMID 07-0051 Team. A placebo-controlled trial of antibiotics for smaller skin abscesses. N Engl J Med. 2017;376(26):2545-2555.

Photo: Shutterstock

For treatment of subcutaneous abscesses that were 5 cm or smaller in diameter, investigators sought to determine if surgical drainage alone was equivalent to surgical drainage plus systemic antibiotics. After their abscess was drained, patients were randomly assigned to receive either clindamycin (300 mg 3 times daily) or trimethoprim-sulfamethoxazole (80 mg/400 mg twice daily) or placebo for 10 days. The primary outcome was clinical cure 7 to 10 days after treatment.

Details of the study

Daum and colleagues enrolled 786 participants (505 adults, 281 children) in the prospective double-blind study. Staphylococcus aureus was isolated from 527 patients (67.0%); methicillin-resistant S aureus (MRSA) was isolated from 388 (49.4%). The cure rate was similar in patients in the clindamycin group (83.1%) and the trimethoprim-sulfamethoxazole group (81.7%), and the cure rate in each antibiotic group was significantly higher than that in the placebo group (68.9%; P<.001 for both comparisons). The difference in treatment effect was specifically limited to patients who had S aureus isolated from their lesions.

Findings at follow-up. At 1 month of  follow-up, new infections were less common in the clindamycin group (6.8%) than in the trimethoprim-sulfamethoxazole group (13.5%; P = .03) or the placebo group (12.4%; P = .06). However, the highest frequency of adverse effects occurred in the patients who received clindamycin (21.9% vs 11.1% vs 12.5%). No adverse effects were judged to be serious, and all resolved without sequela.

Controversy remains on antibiotic use after drainage

This study is important for 2 major reasons. First, soft tissue infections are quite commonand can evolve into serious problems, especially when the offending pathogen is MRSA. Second, controversy exists about whether systemic antibiotics are indicated if the subcutaneous abscess is relatively small and is adequately drained. For example, Talan and colleagues demonstrated that, in settings with a high prevalence of MRSA, surgical drainage combined with trimethoprim-sulfamethoxazole (1 double-strength tablet orally twice daily) was superior to drainage plus placebo.⁸ However, Daum and Gold recently debated the issue of drainage plus antibiotics in a case vignette and reached opposite conclusions.⁹

Read how to avoid C difficile infections in pregnant patients

Antibiotic use, common in the obstetric population, raises risk for C difficile infection

Ruiter-Ligeti J, Vincent S, Czuzoj-Shulman N, Abenhaim HA. Risk factors, incidence, and morbidity associated with obstetric Clostridium difficile infection. Obstet Gynecol. 2018;131(2):387-391.

Photo: Shutterstock

The objective of this investigation was to identify risk factors for Clostridium difficile infection (previously termed pseudomembranous enterocolitis) in obstetric patients. The authors performed a retrospective cohort study using information from a large database maintained by the Agency for Healthcare Research and Quality. This database provides information about inpatient hospital stays in the United States, and it is the largest repository of its kind. It includes data from a sample of 1,000 US hospitals.

Details of the study

Ruiter-Ligeti and colleagues reviewed 13,881,592 births during 1999-2013 and identified 2,757 (0.02%) admissions for delivery complicated by C difficile infection, a rate of 20 admissions per 100,000 deliveries per year (95% CI, 19.13-20.62). The rate of admissions with this diagnosis doubled from 1999 (15 per 100,000) to 2013 (30 per 100,000, P<.001).

Among these obstetric patients, the principal risk factors for C difficile infection were older age, multiple gestation, long-term antibiotic use (not precisely defined), and concurrent diagnosis of inflammatory bowel disease. In addition, patients with pyelonephritis, perineal or cesarean wound infections, or pneumonia also were at increased risk, presumably because those patients required longer courses of broad-spectrum antibiotics.

Of additional note, when compared with women who did not have C difficile infection, patients with infection were more likely to develop a thromboembolic event (38.4 per 1,000), paralytic ileus (58.0 per 1,000), sepsis (46.4 per 1,000), and death (8.0 per 1,000).

Be on guard for C difficile infection in antibiotic-treated obstetric patients

C difficile infection is an uncommon but potentially very serious complication of antibiotic therapy. Given that approximately half of all women admitted for delivery are exposed to antibiotics because of prophylaxis for group B streptococcus infection, prophylaxis for CD, and treatment of chorioamnionitis and puerperal endometritis, clinicians constantly need to be vigilant for this complication.¹¹

Affected patients typically present with frequent loose, watery stools and lower abdominal cramping. In severe cases, blood may be present in the stool, and signs of intestinal distention and even acute peritonitis may be evident. The diagnosis can be established by documenting a positive culture or polymerase chain reaction (PCR) assay for C difficile and a positive cytotoxin assay for toxins A and/or B. In addition, if endoscopy is performed, the characteristic gray membranous plaques can be visualized on the rectal and colonic mucosa.¹¹

Discontinue antibiotic therapy. The first step in managing affected patients is to stop all antibiotics, if possible, or at least the one most likely to be the causative agent of C difficile infection. Patients with relatively mild clinical findings should be treated with oral metronidazole, 500 mg every 8 hours for 10 to 14 days. Patients with severe findings should be treated with oral vancomycin, 500 mg every 6 hours, plus IV metronidazole, 500 mg every 8 hours. The more seriously ill patient must be observed carefully for signs of bowel obstruction, intestinal perforation, peritonitis, and sepsis.

Read about pregnancy outcomes and trimester of maternal Zika infection

Danger for birth defects with maternal Zika infection present in all trimesters, but greatest in first

Hoen B, Schaub B, Funk AL, et al. Pregnancy outcomes after ZIKV infection in French territories in the Americas. N Engl J Med. 2018;378(11):985-994.

Photo: Shutterstock

To estimate the risk of congenital neurologic defects associated with Zika virus infection, Hoen and colleagues conducted a prospective cohort study of pregnant women with symptomatic Zika virus infection who were enrolled during March through November 2016 in French Guiana, Guadeloupe, and Martinique. All women had Zika virus infection confirmed by PCR assay.

Details of the study

The investigators reviewed 546 pregnancies, which resulted in the birth of 555 fetuses and infants. Thirty-nine fetuses and neonates (7%; 95% CI, 5.0-9.5) had neurologic and ocular findings known to be associated with Zika virus infection. Of these, 10 pregnancies were terminated, 1 fetus was stillborn, and 28 were live-born.

Microcephaly (defined as head circumference more than 2 SD below the mean) was present in 32 fetuses and infants (5.8%); 9 had severe microcephaly, defined as head circumference more than 3 SD below the mean. Neurologic and ocular abnormalities were more common when maternal infection occurred during the first trimester (24 of 189 fetuses and infants, 12.7%) compared with infection during the second trimester (9 of 252, 3.6%) or third trimester (6 of 114, 5.3%) (P = .001). 

Studies report similar rates of fetal injury

Zika virus infection primarily is caused by a bite from the Aedes aegypti mosquito. The infection also can be transmitted by sexual contact, laboratory accident, and blood transfusion. Eighty percent of infected persons are asymptomatic. In symptomatic patients, the most common clinical manifestations are low-grade fever, a disseminated maculopapular rash, arthralgias, swelling of the hands and feet, and nonpurulent conjunctivitis.

The most ominous manifestation of congenital Zika virus infection is microcephaly. Other important manifestations include lissencephaly, pachygyria, cortical atrophy, ventriculomegaly, subcortical calcifications, ocular abnormalities, and arthrogryposis. Although most of these abnormalities are immediately visible in the neonate, some may not appear until the child is older.

The present study is an excellent complement to 2 recent reports that defined the risk of Zika virus-related fetal injury in patients in the United States and its territories. Based on an analysis of data from the US Zika Pregnancy Registry, Honein and colleagues reported an overall rate of congenital infection of 6%.¹² The rate of fetal injury was 11% when the mother was infected in the first trimester and 0% when the infection occurred in the second or third trimester. The overall rate of infection and the first trimester rate of infection were similar to those reported by Hoen and colleagues.

Conversely, Shapiro-Mendoza and colleagues evaluated rates of infection in US territories (American Samoa, Puerto Rico, and the US Virgin Islands) and observed cases of fetal injury associated with second- and third-trimester maternal infection.¹³ These authors reported an overall rate of infection of 5% and an 8% rate of infection with first-trimester maternal infection. When maternal infection occurred in the second and third trimesters, the rates of fetal injury were 5% and 4%, respectively, figures almost identical to those reported by Hoen and colleagues. Of note, the investigations by Honein and Shapiro-Mendoza included women with both symptomatic and asymptomatic infection. 

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Photo: Shutterstock

Despite increasing media coverage of human trafficking and the gravity of its many ramifications, I am struck by how often trainees and other clinicians present to me patients for which trafficking is a real potential concern—yet who give me a blank expression when I ask if anyone has screened these patients for being victims of trafficking. I suspect that few of us anticipated, during medical training, that we would be providing care to women who are enslaved.

How large is the problem?

It is impossible to comprehend the true scope of human trafficking. Estimates are that 20.9 million men, women, and children globally are forced into work that they are not free to leave.¹

Although human trafficking is recognized as a global phenomenon, its prevalence in the United States is significant enough that it should prompt the health care community to engage in helping identify and assist victims/survivors: From January until June of 2017, the National Human Trafficking Hotline received 13,807 telephone calls, resulting in reporting of 4,460 cases.² Indeed, from 2015 to 2016 there was a 35.7% increase in the number of hotline cases reported, for a total of 7,572 (6,340—more than 80%—of which regarded females). California had the most cases reported (1,323), followed by Texas (670) and Florida (550); those 3 states also reported an increase in trafficking crime. Vermont (5), Rhode Island (9), and Alaska (10) reported the fewest calls.³

How is trafficking defined?

The United Nations Office on Drugs and Crime defines “trafficking in persons” as:

… recruitment, transportation, transfer, harbouring or receipt of persons, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation. Exploitation shall include, at a minimum, the exploitation of the prostitution of others or other forms of sexual exploitation, forced labour or services, slavery or practices similar to slavery, servitude or the removal of organs.⁴

Traffickers prey on potentially vulnerable people. Girls and young women who have experienced poverty, homelessness, childhood sexual abuse, substance abuse, gender nonconformity, mental illness, or developmental delay are at particular risk.⁵ Children who have had interactions with Child Protective Services, come from a dysfunctional family, or have lived in a community with high crime, political or social unrest, corruption, or gender bias and discrimination are also at increased risk.⁶

Read about clues that raise clinical suspicion

Clues that raise clinical suspicion

A number of potential signs should make providers suspicious about potential human trafficking. Some of those signs are similar to the red flags we see in intimate partner violence, such as:

• having a difficult time talking to the patient alone
• having the accompanying person answer the patient’s questions
• body language that suggests fear, anxiety, or distrust (eg, shifting positions, looking away, appearing withdrawn)
• physical examination inconsistent with the history
• physical injury (especially multiple injuries or injuries in various stages of healing)
• refusal of interpreter services.

Trafficked girls or women may appear overly familiar with sex, have unexpected material possessions, or appear to be giving scripted or memorized answers to queries.⁷ Traffickers often confiscate their victims’ personal identification. They try to prevent victims from knowing their geographic locales: Patients might not have any documentation or awareness of exact surroundings (eg, their home address). Patients may be wearing clothes considered inappropriate for the weather or venue. They may have tattoos that are marks of branding.⁸

Medical consequences of being trafficked are obvious, numerous, and serious

Many medical sequelae that result from trafficking are obvious, given the nature of work that victims are forced to do. For example, overcrowding can lead to infectious disease, such as tuberculosis.⁹ Inadequate access to preventive or basic medical services can result in weight loss, poor dentition, and untreated chronic medical conditions.

If victims are experiencing physical or sexual abuse, they can present with evidence of blunt trauma, ligature marks, skin burns, wounds inflicted by weapons, and vaginal lacerations.¹⁰ A study found that 63% of survivors reported at least 10 somatic symptoms, including headache, fatigue, dizziness, back pain, abdominal or pelvic pain, memory loss, and symptoms of genital infectious disease.¹¹

Girls and women being trafficked for sex may experience many of the sequelae of unprotected intercourse: irregular bleeding, unintended pregnancy, unwanted or unsafe pregnancy termination, vaginal trauma, and sexually transmitted infection (STI).¹² In a study of trafficking survivors, 38% were HIV-positive.¹³

Trafficking survivors can suffer myriad mental health conditions, with high rates of depression, anxiety, posttraumatic stress, and suicidal ideation.¹⁴ A study of 387 survivors found that 12% had attempted to harm themselves or commit suicide the month before they were interviewed.¹⁵

Substance abuse is also a common problem among trafficking victims.¹⁶ One survivor interviewed in a recent study said:

It was much more difficult to work sober because I was dealing with emotions or the pain that I was feeling during intercourse, because when you have sex with people 8, 9, 10 times a day, even more than that, it starts to hurt a lot. And being high made it easier to deal with that and also it made it easier for me to get away from my body while it was happening, place my brain somewhere else.¹⁷

Because of the substantial risk of mental health problems, including substance abuse, among trafficking survivors, the physical exam of a patient should include careful assessment of demeanor and mental health status. Of course, comprehensive inspection for signs of physical or blunt trauma is paramount.

Read about Patient and staff safety during the visit

Patient and staff safety during the visit

Providers should be aware of potential safety concerns, both for the patient and for the staff. Creative strategies should be utilized to screen the patient in private. The use of interpreter services—either in person or over the telephone—should be presented and facilitated as being a routine part of practice. Any person who accompanies the patient should be asked to leave the examining room, either as a statement of practice routine or under the guise of having him (or her) step out to obtain paperwork or provide documentation.

Care of victims

Trauma-informed care should be a guiding principle for trafficking survivors. This involves empowering the patient, who may feel victimized again if asked to undress and undergo multiple physical examinations. Macias-Konstantopoulos noted: “A trauma-informed approach to care acknowledges the pervasiveness and effect of trauma across the life span of the individual, recognizes the vulnerabilities and emotional triggers of trauma survivors, minimizes repeated traumatization and fosters physical, psychological, and emotional safety, recovery, health and well-being.”¹⁸

The patient should be counseled that she has control over her body and can guide different aspects of the examination. For example the provider should discuss: 1) the amount of clothing deemed optimal for an examination, 2) the availability of a support person during the exam (for instance, a nurse or a social worker) if the patient requests one, and 3) utilization of whatever strategies the patient deems optimal for her to be most comfortable during the exam (such as leaving the door slightly ajar or having a mutually agreed-on signal to interrupt the exam).

Routine health care maintenance should be offered, including an assessment of overall physical and dental health and screening for STI and mental health. Screening for substances of abuse should be considered. If indicated, emergency contraception, postexposure HIV prophylaxis, immunizations, and empiric antibiotics for STI should be offered.¹⁹

Screening when indicated by evidence, suspicion, or concern

Unlike the case with intimate partner violence, experts do not recommend universal screening for human trafficking. Clinicians should be comfortable, however, trying to elicit that history when a concern arises, either because of identified risk factors, red flags, or concerns that arise from the findings of the history or physical. Ideally, clinicians should consider becoming comfortable choosing a few screening questions to regularly incorporate into their assessment. The US Department of Health & Human Services (HHS) offers a list of questions that can be utilized (TABLE).²⁰

In January 2018, the Office on Trafficking in Persons, a unit of the HHS Administration for Children and Families, released an “Adult Human Trafficking Screening Tool and Guide.” The document includes 2 excellent tools²¹ that clinicians can utilize to identify patients who should be screened and how to identify and assist survivors (FIGURE 1 and FIGURE 2).

Clinicians, in their encounters with patients, are particularly well-positioned to intersect with, and identify, survivors. Regrettably, such opportunities are often missed—and victims thus remain unidentified and trapped in their circumstances. A study revealed that one-half of survivors who were interviewed reported seeing a physician while they were being trafficked.²² Even more alarming, another study showed that 87.8% of survivors had received health care during their captivity.²³ It is dismaying to know that these patients left those health care settings without receiving the assistance they truly need and with their true circumstances remaining unidentified.

Read about Finding assistance and support

Finding assistance and support

Centers in the United States now provide trauma-informed care for trafficking survivors in a confidential setting (see “Specialized care is increasingly available”).²⁴ A physician who works at a center in New York City noted: “Our survivors told us that more than fear or pain, the feelings that sat with them most often were worthlessness and invisibility. We can do better as physicians and as educators to expose this epidemic and care for its victims.”²⁴

Most clinicians practice in settings that do not have easy access to such subspecialized centers, however. For them, the National Human Trafficking Hotline can be an invaluable resource (see “Hotline is a valuable resource”).²⁵ Law enforcement and social services colleagues also can be useful allies.

Let’s turn our concern and awareness into results

We, as providers of women’s health care, are uniquely positioned to help these most vulnerable of people, many of whom have been stripped of personal documents and denied access to financial resources and community support. As a medical community, we should strive to combat this tragic epidemic, 1 patient at a time.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

The U.S. Supreme Court has struck down a California law that required anti-abortion crisis pregnancy centers to offer women information on abortion services, ruling that the measure violates the First Amendment by compelling speech.

In a concurring opinion, Associate Justice Anthony Kennedy wrote that the California law is a paradigmatic example of the serious threat presented when government seeks to impose its own message in the place of individual speech, thought, and expression.

“Governments must not be allowed to force persons to express a message contrary to their deepest convictions,” Justice Kennedy wrote. “Freedom of speech secures freedom of thought and belief. This law imperils those liberties.”

In a dissenting opinion, Associate Justice Stephen Breyer wrote that the high court’s majority stance contradicts a previous decision in which justices required physicians who performed abortions to give information about adoption services.

“If a state can lawfully require a doctor to tell a woman seeking an abortion about adoption services, why should it not be able, as here, to require a medical counselor to tell a woman seeking prenatal care or other reproductive health care about childbirth and abortion services?” he asked. “As the question suggests, there is no convincing reason to distinguish between information about adoption and information about abortion in this context.”

The Supreme Court’s decision has broad implications in the health care setting and other sectors that physicians and other professionals should celebrate, said Robert McNamara, a senior attorney for the Institute for Justice in Arlington, Va. The professional-speech doctrine that the Supreme Court rejected in the case posed a serious danger to the free-speech rights of health providers, Mr. McNamara said in an interview.  

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

Background: Patients who complain of chest pain make up over a quarter of annual hospital admissions, but not all chest pain is attributable to acute coronary syndrome. The one-page CPC document was developed to facilitate joint decision making between low-risk patients and providers regarding the work-up for chest pain.

Study design: Parallel, randomized, controlled trial.

Setting: Six U.S. medical centers.

Synopsis: After reviewing the CPC tool, patients with low cardiac risk who presented to the ED with chest pain were given the option either to be admitted to the hospital for cardiac testing or to not be admitted and instead follow up with their primary care doctor or a cardiologist within 3 days to determine what further cardiac work-up might be warranted.

Upon reviewing data obtained from 898 patient diaries regarding use of health care services, as well as from billing data from the medical centers, the researchers found no statistically significant difference between patients who used the CPC tool and those treated under usual care with regard to hospital readmission rates, length of stay in the ED, repeat ED visits, or clinic visits. However, at the 45-day follow-up mark, those in the CPC group had undergone fewer tests and cardiac imaging studies (decrease of 125.6 tests/100 patients; 95% confidence interval, 29.3-221.6).

Bottom line: Shared decision making between providers and patients with low cardiac risk factors that used the Chest Pain Choice tool decreased some health care utilization without worsening outcomes.

Citation: Schaffer JT et al. Impact of a shared decision-making intervention on health care utilization: A secondary analysis of the Chest Pain Choice multicenter randomized trial. Acad Emerg Med. 2018 Mar;25(3):293-300.

Dr. Ally is a hospitalist at UC San Diego Health and an assistant clinical professor at the University of California, San Diego.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

The 23rd Congress of the European Hematology Association

STOCKHOLM—Follow-up data suggest that ropeginterferon alfa-2b (ropeg) provides an advantage over hydroxyurea (HU) for patients with polycythemia vera (PV), regardless of their age.

Two-year results from an extension study have shown that, compared to HU, ropeg produces higher rates of complete hematologic response (CHR) and molecular response (MR) in PV patients, including patients age 60 and older.

Additionally, rates of adverse events (AEs) and serious AEs were similar between the ropeg and HU arms.

“In all, I think these data suggest that ropeginterferon alfa-2b provides a valuable, efficacious, and safe new treatment option for PV patients of all ages, including those older than 60 years,” said Jean-Jacques Kiladjian, MD, PhD, of Hôpital Saint-Louis, Université Paris Diderot in Paris, France.

Dr Kiladjian presented these results at the 23rd Congress of the European Hematology Association (EHA) as abstract S132.

The research was sponsored by AOP Orphan Pharmaceuticals AG.

Dr Kiladjian presented data from CONTINUATION-PV, an extension trial of PROUD-PV. Results from PROUD-PV were presented at the 2016 ASH Annual Meeting.

PROUD-PV enrolled 254 patients who were treatment-naive or pretreated with HU. They were randomized to receive ropeg (n=127) or HU (n=127).

CONTINUATION-PV included 95 of the patients on ropeg and 76 of the patients on HU. Dr Kiladjian noted that baseline characteristics were similar between these groups.

CHR

At 24 months, the rate of CHR was 70.5% (67/95) in the ropeg arm and 49.3% (33/67) in the HU arm (RR=1.42, P<0.05).

In patients younger than 60, the rate of CHR was 77.6% in the ropeg arm and 55.9% in the HU arm. In patients age 60 and older, rates of CHR were 63% and 42.4%, respectively.

Dr Kiladjian noted that CHR rates increased over time in ropeg recipients. In PROUD-PV, CHR rates were similar between the ropeg and HU arms at 12 months. However, at 24 months, the CHR rates were higher in ropeg recipients.

Ropeg recipients were also more likely than HU recipients to maintain their CHR from the first occurrence to 24 months.

In patients younger than 60, 49% of the ropeg arm and 17.9% of the HU arm maintained a CHR (P<0.001). In patients age 60 and older, rates of CHR maintenance were 37% and 18.9%, respectively.

MR and JAK2V617F allele burden

Rates of MR at 24 months were 68.1% (64/94) in the ropeg arm and 34.7% (26/75) in the HU arm (RR=1.85, P<0.01).

In patients younger than 60, the rate of MR was 77.1% in the ropeg arm and 33.3% in the HU arm (P<0.001). In patients age 60 and older, MR rates were 58.7% and 36.1%, respectively.

For patients younger than 60, the reduction in JAK2V617F allele burden at 12 months was 29.9% in the ropeg arm and 42.3% in the HU arm. At 24 months, the reductions were 54.8% and 4.5%, respectively (P<0.001).

For patients 60 and older, the reduction in JAK2V617F allele burden at 12 months was 25.2% in the ropeg arm and 37.5% in the HU arm. At 24 months, the reductions were 35.1% and 18.4%, respectively.

Safety          

“I think an important point here is the safety because we assume that [ropeg] is not well tolerated in elderly patients,” Dr Kiladjian said. “So what are the results in this prospective, controlled trial? There was a comparable number of adverse events and serious adverse events in the treatment arms, irrespective of age.”

Dr Kiladjian also pointed out that the number of adverse drug reactions (ADRs) was comparable between the treatment arms for younger patients, and there was a trend toward a lower number of ADRs in the ropeg arm for the patients age 60 and older.

The 4 serious ADRs in the HU patients age 60 and older were acute leukemia, anemia, leukopenia, and granulocytopenia.

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Photo by Bill Branson

A survey of more than 15,000 childhood cancer survivors (CCSs) revealed that many were unconcerned about their risk of health problems.

Thirty-one percent of CCSs said they were “not at all” or “not very” concerned about their future health, and 40% said they were “not at all” or “not very” concerned about developing new cancers.

Researchers say it isn’t clear what’s driving this lack of concern, but it is possible that some CCSs don’t know they have an increased risk of new malignancies and other health problems.

“Other possibilities include that some survivors may actually be aware of their increased risks and choose not to be concerned, or it may even be that some survivors are, indeed, following health guidelines and working with healthcare providers, leading to their lack of concern,” said Todd Gibson, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

Dr Gibson and his colleagues conducted this research and reported the results in Cancer.

The researchers analyzed data on 15,620 CCSs and 3991 of their siblings who did not have a history of cancer. The data came from questionnaires administered to participants in the Childhood Cancer Survivor Study.

At baseline, the median time from CCSs’ cancer diagnosis was 17 years (interquartile range [IQR], 14-21). Their median age at baseline was 26 (IQR, 22-31 years), and the siblings’ median age was 29 (IQR, 24-35).

When respondents were asked about their level of concern regarding their future health, the answers were as follows:

• 12% of both CCSs and siblings were “not at all concerned”
• 18.7% of CCSs and 21.6% of siblings were “not very concerned”
• 23.2% of CCSs and 24.1% of siblings were “concerned”
• 21.4% of CCSs and 22.2% of siblings were “somewhat concerned”
• 24.8% of CCSs and 20.1% of siblings were “very concerned.”

When respondents were asked to rate their level of concern about developing a new cancer, the answers were as follows:

• 17.2% of CCSs and 16.3% of siblings were “not at all concerned”
• 22.8% of CCSs and 22.2% of siblings were “not very concerned”
• 21.1% of CCSs and 25.1% of siblings were “concerned”
• 18.3% of CCSs and 18.4% of siblings were “somewhat concerned”
• 20.6% of CCSs and 18.1% of siblings were “very concerned.”

When the researchers adjusted for age, sex, race/ethnicity, education, and decade of diagnosis, CCSs were only slightly more likely than siblings to report concern about future health (relative risk, 1.12) or subsequent cancer (relative risk, 1.02).

“That similarity [between CCS and sibling answers] was really the major surprise in our findings,” Dr Gibson said. “Despite the fact that survivors have such a greatly increased risk of both second cancers and other health problems, their perception of risk was not always commensurate with their actual risk.”

The researchers did find that CCSs were more likely to report concern about future health or developing cancer if they were female, non-Hispanic black or Hispanic, older, identified as having clinical anxiety, or had already experienced a grade 3/4 chronic condition or subsequent cancer.

However, it isn’t clear why some CCSs are concerned about their future health and others are not.

“At this point, we can only speculate, but the most obvious reason [for lack of concern] would be that survivors may not fully understand their risks,” Dr Gibson said. “We do know from prior studies that not all survivors are fully aware of the specific treatments they received and how those might increase their risks of late effects.”

“If, however, survivors are aware but not motivated or sufficiently aroused to be concerned, then more motivational education will have to be developed. In any case, these findings offer a teaching point that we can use to emphasize to all survivors that they need to understand their risks.”

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

Image by Lance Liotta

The US Food and Drug Administration (FDA) has accepted for priority review a new drug application (NDA) for glasdegib, an oral SMO inhibitor.

With this NDA, Pfizer is seeking approval for glasdegib in combination with low-dose cytarabine (LDAC) as a treatment for adults with previously untreated acute myeloid leukemia (AML).

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions.

The agency intends to take action on a priority review application within 6 months of receiving it rather than the standard 10 months.

The FDA expects to make a decision on the NDA for glasdegib by December 2018.

The NDA is supported by results from the phase 2 BRIGHT 1003 study. Results from this trial were presented at the 2016 ASH Annual Meeting.

The trial was a comparison of glasdegib plus LDAC (n=88) to LDAC alone (n=44) in patients with previously untreated AML or high-risk myelodysplastic syndromes who were not eligible for intensive chemotherapy.

Results demonstrated a significant improvement in overall survival with glasdegib. The median overall survival was 8.8 months in the glasdegib arm and 4.9 months in the LDAC-alone arm.

This difference represented a 49.9% reduction in the risk of death for patients treated with glasdegib plus LDAC (hazard ratio=0.501; 95% CI: 0.334, 0.752; one-sided P-value=0.0003).

The most frequent adverse events—occurring in at least 30% of patients in the glasdegib arm and LDAC-alone arm, respectively—were anemia (45% vs 42%), febrile neutropenia (36% vs 27%), nausea (36% vs 12%), decreased appetite (32% vs 12%), fatigue (31% vs 20%), and thrombocytopenia (30% vs 27%).

The most frequently reported serious adverse events—occurring in at least 15%  of patients in the glasdegib and LDAC-alone arms, respectively—were febrile neutropenia (29% vs 20%) and pneumonia (21% vs 17%).

A phase 3 trial of glasdegib in AML began enrolling earlier this year. In this trial (BRIGHT AML 1019; NCT03416179), researchers are evaluating glasdegib plus intensive or non-intensive chemotherapy in patients with newly diagnosed AML.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

The FP thought the flat lesion (arrow) might be a nevus sebaceous (NS) and that the new area could be a malignant transformation.

The FP explained that a biopsy would be needed to learn more about the lesion. He explained that he would remove the area that was friable and bleeding along with part of the original flat lesion. After injecting the area with 1% lidocaine and epinephrine, a shave biopsy was performed using a DermaBlade. (See the Watch & Learn video on “Shave biopsy.”) The bleeding was stopped using aluminum chloride in water and some electrosurgery. The pathology results revealed syringocystadenoma papilliferum growing within an NS. This benign tumor is rare, but may develop within an NS.

The FP reassured the family that there was no skin cancer. The FP also referred the patient for full removal of the NS and any remnant of the syringocystadenoma papilliferum to avoid future growth and prevent additional bleeding.

‌

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Smith M. Epidermal nevus and nevus sebaceous. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine, 2nd ed. New York, NY: McGraw-Hill; 2013:958-962.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/.

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.

Clinical question: Among patients with septic shock undergoing mechanical ventilation, does hydrocortisone reduce 90-day mortality?

Background: Septic shock is associated with a significant mortality risk, and there is no proven pharmacologic treatment other than fluids, vasopressors, and antimicrobials. Prior randomized, controlled trials have resulted in mixed outcomes, and meta-analyses and clinical practice guidelines also have not provided consistent guidance.

Study design: Randomized, controlled, double-blinded trial.

Setting: Medical centers in Australia, Denmark, New Zealand, Saudi Arabia, and the United Kingdom.

Synopsis: Over a 4-year period from 2013 to 2017, 3,658 patients with septic shock undergoing mechanical ventilation were randomized to receive either a continuous infusion of 200 mg/day of hydrocortisone for 7 days or placebo. The primary outcome, death within 90 days, occurred in 511 patients (27.9%) in the hydrocortisone group and in 526 patients (28.8%) in the placebo group (P = .50).

Dr. Huang is associate chief of the division of hospital medicine at UC San Diego Health and an associate professor of medicine at the University of California, San Diego.