Obstetrics

FORT LAUDERDALE, FLA. — Researchers have developed an assay that can be used in noninvasive prenatal testing (NIPT) of cell-free fetal DNA present in maternal blood to identify sickle cell disease without using paternal DNA, which could provide an alternative to other invasive methods, according to results of a pilot study.

Richard Mark Kirkner/MDedge News

The novel NIPT assay had a sensitivity greater than 98% and a specificity greater than 99% in early-phase analysis, Vivien A. Sheehan, MD, PhD, of Baylor College of Medicine, Houston, reported at the annual meeting of the Foundation for Sickle Cell Disease Research.

“Noninvasive prenatal testing is a safe and affordable alternative to chorionic villus sampling or amniocentesis and can be performed earlier in pregnancy,” Dr. Sheehan said. “There is a lot of potential for the growth of this test and its impact not only in this country, but worldwide.”

The NIPT uses cell-free fetal DNA from the pregnant mother’s peripheral blood.

“We know that fetal DNA is present in maternal blood and can comprise about 10% by the 10th week of gestation, and it increases as pregnancy progresses,” Dr. Sheehan said.

Maternal alleles from the baby and mother, as well as paternal alleles from the baby, can be identified in maternal blood. “By analyzing cell-free DNA in maternal blood via next-generation sequencing, we can determine fetal disease status,” she said.

Dr. Sheehan noted some reports have supported the use of NIPT for identifying trisomy and aneuploidy, but NIPT has encountered some challenges in identifying autosomal recessive disorders such as sickle cell disease.

To accomplish this, researchers at Baylor and test developer BillionToOne, developed a novel sequencing-based molecular counting strategy that can help measure the ratio of mutant versus normal alleles, Dr. Sheehan said.

The results obtained to date indicate that the assay reliably detects fetal sickle cell disease status when the fetal fraction is as low as 5%, the same limit as aneuploidy NIPT.

The method uses a commercial DNA extraction kit to isolate and purify cell-free fetal DNA from a single blood draw, then performs sickle cell disease NIPT assays using proprietary reagents, Dr. Sheehan explained. The protocol includes bioinformatic analyses that are used to determine hemoglobin S (HbS) mutation ratio and fetal disease status.

The pilot study had two phases. In the first phase, which has been completed, researchers sought to optimize the beta-globin gene probes using cell-free fetal DNA from compound heterozygote patients with sickle cell disease to establish the expected ratio of HbS mutation.

In the second phase, the researchers validated the test on pregnant women with sickle cell trait or sickle cell disease by performing the assay in maternal samples collected between 10-35 weeks of gestation.

Among the six controls who have sickle cell trait, the NIPT reported no false positives when compared with the state newborn screen results, Dr. Sheehan said. For the one participant with sickle cell anemia, the NIPT and newborn screening concurred on two blood draws, but the NIPT was inconclusive on the first blood draw obtained at 10 weeks’ gestation because of low levels of cell-free fetal DNA.

Overall, the analysis showed an analytical sensitivity greater than 98% and a specificity greater than 99%, even in the absence of paternal DNA, the study found.

BillionToOne developed the test. Dr. Sheehan reported having no financial relationships to disclose.

SOURCE: Sheehan VA et al. FSCDR 2019, Abstract JSCDH-D-19-00048.

FORT LAUDERDALE, FLA. — Researchers have developed an assay that can be used in noninvasive prenatal testing (NIPT) of cell-free fetal DNA present in maternal blood to identify sickle cell disease without using paternal DNA, which could provide an alternative to other invasive methods, according to results of a pilot study.

Richard Mark Kirkner/MDedge News

The novel NIPT assay had a sensitivity greater than 98% and a specificity greater than 99% in early-phase analysis, Vivien A. Sheehan, MD, PhD, of Baylor College of Medicine, Houston, reported at the annual meeting of the Foundation for Sickle Cell Disease Research.

“Noninvasive prenatal testing is a safe and affordable alternative to chorionic villus sampling or amniocentesis and can be performed earlier in pregnancy,” Dr. Sheehan said. “There is a lot of potential for the growth of this test and its impact not only in this country, but worldwide.”

The NIPT uses cell-free fetal DNA from the pregnant mother’s peripheral blood.

“We know that fetal DNA is present in maternal blood and can comprise about 10% by the 10th week of gestation, and it increases as pregnancy progresses,” Dr. Sheehan said.

Maternal alleles from the baby and mother, as well as paternal alleles from the baby, can be identified in maternal blood. “By analyzing cell-free DNA in maternal blood via next-generation sequencing, we can determine fetal disease status,” she said.

Dr. Sheehan noted some reports have supported the use of NIPT for identifying trisomy and aneuploidy, but NIPT has encountered some challenges in identifying autosomal recessive disorders such as sickle cell disease.

To accomplish this, researchers at Baylor and test developer BillionToOne, developed a novel sequencing-based molecular counting strategy that can help measure the ratio of mutant versus normal alleles, Dr. Sheehan said.

The results obtained to date indicate that the assay reliably detects fetal sickle cell disease status when the fetal fraction is as low as 5%, the same limit as aneuploidy NIPT.

The method uses a commercial DNA extraction kit to isolate and purify cell-free fetal DNA from a single blood draw, then performs sickle cell disease NIPT assays using proprietary reagents, Dr. Sheehan explained. The protocol includes bioinformatic analyses that are used to determine hemoglobin S (HbS) mutation ratio and fetal disease status.

The pilot study had two phases. In the first phase, which has been completed, researchers sought to optimize the beta-globin gene probes using cell-free fetal DNA from compound heterozygote patients with sickle cell disease to establish the expected ratio of HbS mutation.

In the second phase, the researchers validated the test on pregnant women with sickle cell trait or sickle cell disease by performing the assay in maternal samples collected between 10-35 weeks of gestation.

Among the six controls who have sickle cell trait, the NIPT reported no false positives when compared with the state newborn screen results, Dr. Sheehan said. For the one participant with sickle cell anemia, the NIPT and newborn screening concurred on two blood draws, but the NIPT was inconclusive on the first blood draw obtained at 10 weeks’ gestation because of low levels of cell-free fetal DNA.

Overall, the analysis showed an analytical sensitivity greater than 98% and a specificity greater than 99%, even in the absence of paternal DNA, the study found.

BillionToOne developed the test. Dr. Sheehan reported having no financial relationships to disclose.

SOURCE: Sheehan VA et al. FSCDR 2019, Abstract JSCDH-D-19-00048.

FORT LAUDERDALE, FLA. — Researchers have developed an assay that can be used in noninvasive prenatal testing (NIPT) of cell-free fetal DNA present in maternal blood to identify sickle cell disease without using paternal DNA, which could provide an alternative to other invasive methods, according to results of a pilot study.

Richard Mark Kirkner/MDedge News

The novel NIPT assay had a sensitivity greater than 98% and a specificity greater than 99% in early-phase analysis, Vivien A. Sheehan, MD, PhD, of Baylor College of Medicine, Houston, reported at the annual meeting of the Foundation for Sickle Cell Disease Research.

“Noninvasive prenatal testing is a safe and affordable alternative to chorionic villus sampling or amniocentesis and can be performed earlier in pregnancy,” Dr. Sheehan said. “There is a lot of potential for the growth of this test and its impact not only in this country, but worldwide.”

The NIPT uses cell-free fetal DNA from the pregnant mother’s peripheral blood.

“We know that fetal DNA is present in maternal blood and can comprise about 10% by the 10th week of gestation, and it increases as pregnancy progresses,” Dr. Sheehan said.

Maternal alleles from the baby and mother, as well as paternal alleles from the baby, can be identified in maternal blood. “By analyzing cell-free DNA in maternal blood via next-generation sequencing, we can determine fetal disease status,” she said.

Dr. Sheehan noted some reports have supported the use of NIPT for identifying trisomy and aneuploidy, but NIPT has encountered some challenges in identifying autosomal recessive disorders such as sickle cell disease.

To accomplish this, researchers at Baylor and test developer BillionToOne, developed a novel sequencing-based molecular counting strategy that can help measure the ratio of mutant versus normal alleles, Dr. Sheehan said.

The results obtained to date indicate that the assay reliably detects fetal sickle cell disease status when the fetal fraction is as low as 5%, the same limit as aneuploidy NIPT.

The method uses a commercial DNA extraction kit to isolate and purify cell-free fetal DNA from a single blood draw, then performs sickle cell disease NIPT assays using proprietary reagents, Dr. Sheehan explained. The protocol includes bioinformatic analyses that are used to determine hemoglobin S (HbS) mutation ratio and fetal disease status.

The pilot study had two phases. In the first phase, which has been completed, researchers sought to optimize the beta-globin gene probes using cell-free fetal DNA from compound heterozygote patients with sickle cell disease to establish the expected ratio of HbS mutation.

In the second phase, the researchers validated the test on pregnant women with sickle cell trait or sickle cell disease by performing the assay in maternal samples collected between 10-35 weeks of gestation.

Among the six controls who have sickle cell trait, the NIPT reported no false positives when compared with the state newborn screen results, Dr. Sheehan said. For the one participant with sickle cell anemia, the NIPT and newborn screening concurred on two blood draws, but the NIPT was inconclusive on the first blood draw obtained at 10 weeks’ gestation because of low levels of cell-free fetal DNA.

Overall, the analysis showed an analytical sensitivity greater than 98% and a specificity greater than 99%, even in the absence of paternal DNA, the study found.

BillionToOne developed the test. Dr. Sheehan reported having no financial relationships to disclose.

SOURCE: Sheehan VA et al. FSCDR 2019, Abstract JSCDH-D-19-00048.

A policy of universal screening of perinatal depression for women receiving prenatal care at an academic medical center led to more regular screening of depression, and made it more likely that women with postpartum depression would be referred for treatment, according to recent research published in Obstetrics & Gynecology.

©monkeybusinessimages/Thinkstock

Emily S. Miller, MD, MPH, at Northwestern University, Chicago, and colleagues performed a retrospective study of 5,127 women receiving prenatal care at the center between 2008 and 2015. They divided the group into those who were at the center before (n = 1,122) and after (n = 4,005) initiation of a policy on universal perinatal depression screening, which consisted of two antenatal screenings at the first prenatal visit and third trimester, and one postpartum screening.

After initiation of the policy, screening increased during the first trimester (0.1% vs. 66%; P less than .001), the third trimester (0% vs. 43%; P less than .001), and at the postpartum visit (70% vs. 90%; P less than .001). Screening continued to increase at both prenatal visits, while screening prevalence remained the same for the postpartum visit. Women who had a positive result after postpartum depression screening were more than twice as likely to receive treatment or a referral for their depression in the post-policy group (30% vs. 65%).

Katrina S. Mark, MD, associate professor of the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, said in an interview that the study “brings attention to an incredibly important topic.

“The researchers in this study found that, after implementation of a new policy regarding antenatal and postpartum depression screening, there was a significant increase in women who were screened during and after pregnancy as well as an increase in those who were appropriately treated,” she said. “Importantly, however, their intervention was not only a policy, but also provided education and resources to providers to increase awareness and knowledge surrounding the subject of depression and how to screen and treat this common condition.”

Dr. Miller and colleagues noted their study was limited because they were unable to determine whether prescriptions were filled or if referrals led to actual provider visits. Other obstacles to mental health care in the perinatal period also exist in the form of logistic barriers to appointments and stigma about mental health treatment.

“Depression is common, and screening and treatment during pregnancy and the postpartum period are extremely important to improve maternal and child health. As the authors point out, there has historically been a hesitation among obstetric providers to screen for depression,” Dr. Mark said. “My suspicion is that this hesitation is not because of a lack of awareness, but rather due to a lack of knowledge of what to do when a woman has a positive screen. In my opinion, the take-home message from this study is that implementation of a policy is possible and can lead to real change if it is accompanied by the appropriate resources and education.”

This study was funded by the Maternal-Fetal Medicine/Lumara Health Policy Award, and grants from the Eunice Kennedy Shriver National Institute of Child and Human Development and from the National Institutes of Health’s National Center for Advancing Translational Sciences. The authors reported no conflicts of interest.
 

SOURCE: Miller ES et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003369.

A policy of universal screening of perinatal depression for women receiving prenatal care at an academic medical center led to more regular screening of depression, and made it more likely that women with postpartum depression would be referred for treatment, according to recent research published in Obstetrics & Gynecology.

©monkeybusinessimages/Thinkstock

Emily S. Miller, MD, MPH, at Northwestern University, Chicago, and colleagues performed a retrospective study of 5,127 women receiving prenatal care at the center between 2008 and 2015. They divided the group into those who were at the center before (n = 1,122) and after (n = 4,005) initiation of a policy on universal perinatal depression screening, which consisted of two antenatal screenings at the first prenatal visit and third trimester, and one postpartum screening.

After initiation of the policy, screening increased during the first trimester (0.1% vs. 66%; P less than .001), the third trimester (0% vs. 43%; P less than .001), and at the postpartum visit (70% vs. 90%; P less than .001). Screening continued to increase at both prenatal visits, while screening prevalence remained the same for the postpartum visit. Women who had a positive result after postpartum depression screening were more than twice as likely to receive treatment or a referral for their depression in the post-policy group (30% vs. 65%).

Katrina S. Mark, MD, associate professor of the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, said in an interview that the study “brings attention to an incredibly important topic.

“The researchers in this study found that, after implementation of a new policy regarding antenatal and postpartum depression screening, there was a significant increase in women who were screened during and after pregnancy as well as an increase in those who were appropriately treated,” she said. “Importantly, however, their intervention was not only a policy, but also provided education and resources to providers to increase awareness and knowledge surrounding the subject of depression and how to screen and treat this common condition.”

Dr. Miller and colleagues noted their study was limited because they were unable to determine whether prescriptions were filled or if referrals led to actual provider visits. Other obstacles to mental health care in the perinatal period also exist in the form of logistic barriers to appointments and stigma about mental health treatment.

“Depression is common, and screening and treatment during pregnancy and the postpartum period are extremely important to improve maternal and child health. As the authors point out, there has historically been a hesitation among obstetric providers to screen for depression,” Dr. Mark said. “My suspicion is that this hesitation is not because of a lack of awareness, but rather due to a lack of knowledge of what to do when a woman has a positive screen. In my opinion, the take-home message from this study is that implementation of a policy is possible and can lead to real change if it is accompanied by the appropriate resources and education.”

This study was funded by the Maternal-Fetal Medicine/Lumara Health Policy Award, and grants from the Eunice Kennedy Shriver National Institute of Child and Human Development and from the National Institutes of Health’s National Center for Advancing Translational Sciences. The authors reported no conflicts of interest.
 

SOURCE: Miller ES et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003369.

A policy of universal screening of perinatal depression for women receiving prenatal care at an academic medical center led to more regular screening of depression, and made it more likely that women with postpartum depression would be referred for treatment, according to recent research published in Obstetrics & Gynecology.

©monkeybusinessimages/Thinkstock

Emily S. Miller, MD, MPH, at Northwestern University, Chicago, and colleagues performed a retrospective study of 5,127 women receiving prenatal care at the center between 2008 and 2015. They divided the group into those who were at the center before (n = 1,122) and after (n = 4,005) initiation of a policy on universal perinatal depression screening, which consisted of two antenatal screenings at the first prenatal visit and third trimester, and one postpartum screening.

After initiation of the policy, screening increased during the first trimester (0.1% vs. 66%; P less than .001), the third trimester (0% vs. 43%; P less than .001), and at the postpartum visit (70% vs. 90%; P less than .001). Screening continued to increase at both prenatal visits, while screening prevalence remained the same for the postpartum visit. Women who had a positive result after postpartum depression screening were more than twice as likely to receive treatment or a referral for their depression in the post-policy group (30% vs. 65%).

Katrina S. Mark, MD, associate professor of the department of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, said in an interview that the study “brings attention to an incredibly important topic.

“The researchers in this study found that, after implementation of a new policy regarding antenatal and postpartum depression screening, there was a significant increase in women who were screened during and after pregnancy as well as an increase in those who were appropriately treated,” she said. “Importantly, however, their intervention was not only a policy, but also provided education and resources to providers to increase awareness and knowledge surrounding the subject of depression and how to screen and treat this common condition.”

Dr. Miller and colleagues noted their study was limited because they were unable to determine whether prescriptions were filled or if referrals led to actual provider visits. Other obstacles to mental health care in the perinatal period also exist in the form of logistic barriers to appointments and stigma about mental health treatment.

“Depression is common, and screening and treatment during pregnancy and the postpartum period are extremely important to improve maternal and child health. As the authors point out, there has historically been a hesitation among obstetric providers to screen for depression,” Dr. Mark said. “My suspicion is that this hesitation is not because of a lack of awareness, but rather due to a lack of knowledge of what to do when a woman has a positive screen. In my opinion, the take-home message from this study is that implementation of a policy is possible and can lead to real change if it is accompanied by the appropriate resources and education.”

This study was funded by the Maternal-Fetal Medicine/Lumara Health Policy Award, and grants from the Eunice Kennedy Shriver National Institute of Child and Human Development and from the National Institutes of Health’s National Center for Advancing Translational Sciences. The authors reported no conflicts of interest.
 

SOURCE: Miller ES et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003369.

Patients who underwent medication abortion under the care of a clinician through a telemedicine service did not have any difference in outcomes, compared with patients who saw a clinician in person, according to a study in Obstetrics & Gynecology.

“To the extent that state bans on telemedicine for abortion rest on arguments of improved patient safety, the findings of this and previous studies do not support such contentions,” Julia E. Kohn, PhD, MPA, from Planned Parenthood Federation of America in New York and colleagues wrote.

Dr. Kohn, with colleagues from Ibis Reproductive Health, Bixby Center for Global Reproductive Health, and the University of California, San Francisco, assessed the outcomes of 5,952 patients who underwent medication abortion either through a telemedicine visit (738 patients) or in-person visit (5,214 patients). In the telemedicine group, the patients took mifepristone in view of the clinician over a secure videoconference platform followed by misoprostol 48 hours later as dispensed by a health center. Patients in the telemedicine group had a slightly older gestational age (50 days), compared with patients in the standard-care group (49 days).

Telemedicine patients received the same on-site care as those patients who saw a clinician in person, including informed consent, lab testing, and ultrasound scans. Patients who received care over telemedicine also received the same follow-up instructions as those who received standard of care, which consisted of an ultrasound evaluation 1-2 weeks after the visit, or human chorionic gonadotropin (hCG) testing.

While telemedicine patients were less likely to follow up at 45 days than were patients who received standard care (60% vs. 77%; prevalence ratio, 0.83; 95% confidence interval, 0.78-0.88), they also were less likely to have an ongoing pregnancy at follow-up (0.5% vs. 1.8%; adjusted odds ratio, 0.23; 95% CI, 0.14–0.39) or undergo an aspiration procedure (1% vs. 5%; aOR, 0.28; 95% CI, 0.17–0.46) than were standard-of-care patients. With regard to adverse events, the rate was less than 1% for each group, and the researchers reported no maternal deaths in either group.

Eve Espey, MD, MPH, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, commented that this study expands the evidence of positive outcomes of telemedicine abortion to four new states: Alaska, Idaho, Nevada, and Washington.

“Abortion access is limited in the large rural states in which the study was conducted; across the country, abortion access is increasingly limited by restrictive legislation including telemedicine abortion bans,” she said in an interview. “This reassuring study helps demonstrate the safety of telemedicine medication abortion and highlights the role of telemedicine in improving health equity by increasing access to a critical health care service.”

The researchers said the results were limited in that most telemedicine care was centered in one state, Nevada, and the sample size was inadequate to do per-state comparisons of in-person visits and telemedicine. In addition, follow-up data was available for 75% of patients, which meant approximately one-fourth of patients did not follow up with the health center.

The Susan T. Buffett Foundation provided a grant for this study. Dr. Grossman receives consulting payments from Planned Parenthood Federation of America for work related to telemedicine for medication abortion. The other authors reported no relevant conflicts of interest.

SOURCE: Kohn JE et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003357.

Patients who underwent medication abortion under the care of a clinician through a telemedicine service did not have any difference in outcomes, compared with patients who saw a clinician in person, according to a study in Obstetrics & Gynecology.

“To the extent that state bans on telemedicine for abortion rest on arguments of improved patient safety, the findings of this and previous studies do not support such contentions,” Julia E. Kohn, PhD, MPA, from Planned Parenthood Federation of America in New York and colleagues wrote.

Dr. Kohn, with colleagues from Ibis Reproductive Health, Bixby Center for Global Reproductive Health, and the University of California, San Francisco, assessed the outcomes of 5,952 patients who underwent medication abortion either through a telemedicine visit (738 patients) or in-person visit (5,214 patients). In the telemedicine group, the patients took mifepristone in view of the clinician over a secure videoconference platform followed by misoprostol 48 hours later as dispensed by a health center. Patients in the telemedicine group had a slightly older gestational age (50 days), compared with patients in the standard-care group (49 days).

Telemedicine patients received the same on-site care as those patients who saw a clinician in person, including informed consent, lab testing, and ultrasound scans. Patients who received care over telemedicine also received the same follow-up instructions as those who received standard of care, which consisted of an ultrasound evaluation 1-2 weeks after the visit, or human chorionic gonadotropin (hCG) testing.

While telemedicine patients were less likely to follow up at 45 days than were patients who received standard care (60% vs. 77%; prevalence ratio, 0.83; 95% confidence interval, 0.78-0.88), they also were less likely to have an ongoing pregnancy at follow-up (0.5% vs. 1.8%; adjusted odds ratio, 0.23; 95% CI, 0.14–0.39) or undergo an aspiration procedure (1% vs. 5%; aOR, 0.28; 95% CI, 0.17–0.46) than were standard-of-care patients. With regard to adverse events, the rate was less than 1% for each group, and the researchers reported no maternal deaths in either group.

Eve Espey, MD, MPH, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, commented that this study expands the evidence of positive outcomes of telemedicine abortion to four new states: Alaska, Idaho, Nevada, and Washington.

“Abortion access is limited in the large rural states in which the study was conducted; across the country, abortion access is increasingly limited by restrictive legislation including telemedicine abortion bans,” she said in an interview. “This reassuring study helps demonstrate the safety of telemedicine medication abortion and highlights the role of telemedicine in improving health equity by increasing access to a critical health care service.”

The researchers said the results were limited in that most telemedicine care was centered in one state, Nevada, and the sample size was inadequate to do per-state comparisons of in-person visits and telemedicine. In addition, follow-up data was available for 75% of patients, which meant approximately one-fourth of patients did not follow up with the health center.

The Susan T. Buffett Foundation provided a grant for this study. Dr. Grossman receives consulting payments from Planned Parenthood Federation of America for work related to telemedicine for medication abortion. The other authors reported no relevant conflicts of interest.

SOURCE: Kohn JE et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003357.

Patients who underwent medication abortion under the care of a clinician through a telemedicine service did not have any difference in outcomes, compared with patients who saw a clinician in person, according to a study in Obstetrics & Gynecology.

“To the extent that state bans on telemedicine for abortion rest on arguments of improved patient safety, the findings of this and previous studies do not support such contentions,” Julia E. Kohn, PhD, MPA, from Planned Parenthood Federation of America in New York and colleagues wrote.

Dr. Kohn, with colleagues from Ibis Reproductive Health, Bixby Center for Global Reproductive Health, and the University of California, San Francisco, assessed the outcomes of 5,952 patients who underwent medication abortion either through a telemedicine visit (738 patients) or in-person visit (5,214 patients). In the telemedicine group, the patients took mifepristone in view of the clinician over a secure videoconference platform followed by misoprostol 48 hours later as dispensed by a health center. Patients in the telemedicine group had a slightly older gestational age (50 days), compared with patients in the standard-care group (49 days).

Telemedicine patients received the same on-site care as those patients who saw a clinician in person, including informed consent, lab testing, and ultrasound scans. Patients who received care over telemedicine also received the same follow-up instructions as those who received standard of care, which consisted of an ultrasound evaluation 1-2 weeks after the visit, or human chorionic gonadotropin (hCG) testing.

While telemedicine patients were less likely to follow up at 45 days than were patients who received standard care (60% vs. 77%; prevalence ratio, 0.83; 95% confidence interval, 0.78-0.88), they also were less likely to have an ongoing pregnancy at follow-up (0.5% vs. 1.8%; adjusted odds ratio, 0.23; 95% CI, 0.14–0.39) or undergo an aspiration procedure (1% vs. 5%; aOR, 0.28; 95% CI, 0.17–0.46) than were standard-of-care patients. With regard to adverse events, the rate was less than 1% for each group, and the researchers reported no maternal deaths in either group.

Eve Espey, MD, MPH, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque, commented that this study expands the evidence of positive outcomes of telemedicine abortion to four new states: Alaska, Idaho, Nevada, and Washington.

“Abortion access is limited in the large rural states in which the study was conducted; across the country, abortion access is increasingly limited by restrictive legislation including telemedicine abortion bans,” she said in an interview. “This reassuring study helps demonstrate the safety of telemedicine medication abortion and highlights the role of telemedicine in improving health equity by increasing access to a critical health care service.”

The researchers said the results were limited in that most telemedicine care was centered in one state, Nevada, and the sample size was inadequate to do per-state comparisons of in-person visits and telemedicine. In addition, follow-up data was available for 75% of patients, which meant approximately one-fourth of patients did not follow up with the health center.

The Susan T. Buffett Foundation provided a grant for this study. Dr. Grossman receives consulting payments from Planned Parenthood Federation of America for work related to telemedicine for medication abortion. The other authors reported no relevant conflicts of interest.

SOURCE: Kohn JE et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003357.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Among pregnant women with inherited bleeding disorders, having a contraindication to regional anesthesia appears not to impact labor outcomes, according to a retrospective analysis.

oceandigital/Thinkstock

“The purpose of this study was to determine the anesthetic use in labour in a cohort of women with inherited bleeding disorders,” wrote Sean C. Boyd, of Coombe Women & Infants University Hospital in Dublin, Ireland, and colleagues. The findings were reported in the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study comprised 97 pregnant women with an inherited bleeding disorder and outcomes related to 130 delivered newborns.

The researchers reviewed medical records of patients with a variety of inherited bleeding disorders: type 1 von Willebrand disease (VWD), deficiencies of factors VII, VIII, IX, X, and XI, combined deficiencies, and others.

Various clinical data, including both obstetric and anesthetic outcomes, were collected from January 2011 to December 2016.

When researchers compared pregnancies where regional anesthesia was contraindicated to those in which it was considered safe, women with a contraindication were more likely to receive general anesthesia for cesarean section (20% vs. 1%), more likely to use a remifentanil infusion (31% vs. 0), and more likely to require prophylactic hemostatic support for delivery (61% vs. 1%).

Vaginal (71% vs. 65%; P = .4) and caesarean section (29% vs. 32%; P = .28) delivery rates were similar between the two groups.

Rates of postpartum hemorrhage were greater in pregnancies where regional anesthesia was contraindicated (24% vs. 12%), but not significantly different (P = .07). No cases of vertebral canal hematoma or neonatal hemorrhage were reported among participants.

“Women are anxious about analgesia and anesthesia in labour and understandably, more so, when they are aware that they are unable to have an epidural or spinal,” the researchers wrote. “This study shows what alternative analgesia is used in labour and, reassuringly, that labour outcome is the same.”

Two key limitations of the study were the small sample size and the wide range of included bleeding disorders.

No funding sources were reported. The authors did not report conflicts of interest.

SOURCE: Boyd SC et al. Eur J Obstet Gynecol Reprod Biol. 2019 Jun 3. doi: 10.1016/j.ejogrb.2019.05.043.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

Children exposed to opioids via maternal use during pregnancy were at increased risk of perinatal and postnatal physical and neurodevelopmental disabilities, according to data from more than 8,000 children.

Antonio_Diaz/Thinkstock

Previous studies have shown the increased risk of a range of health problems associated with maternal opioid use, including neonatal abstinence syndrome (NAS), but data on the long-term consequences of in utero opioid exposure are limited, wrote Romuladus E. Azuine, DrPH, MPH, of the U.S. Department of Health and Human Services, Rockville, Md., and colleagues.

In a study published in JAMA Network Open, the researchers reviewed data from 8,509 mother/newborn pairs in the Boston Birth Cohort, a database that included a large urban, low-income, multiethnic population of women who had singleton births at the Boston Medical Center starting in 1998.

A total of 454 infants (5%) experienced prenatal opioid exposure. Mothers were interviewed 48-72 hours after delivery about sociodemographic factors, drug use, smoking, and alcohol use.

The risk of small for gestational age and preterm birth were significantly higher in babies exposed to opioids (OR 1.87 and OR 1.49, respectively), compared with unexposed newborns.

Children’s developmental outcomes were collected starting in 2003 based on electronic medical records. A total of 3,153 mother-newborn pairs were enrolled in a postnatal follow-up study. For preschoolers, prenatal opioid exposure was associated with increased risk of lack of expected physiological development and conduct disorder/emotional disturbance (OR 1.80 and OR 2.13, respectively), compared with unexposed children. School-aged children with prenatal opioid exposure had an increased risk of ADHD (OR 2.55).

The incidence of NAS in the study population was at least 24 per 1,000 hospital births starting in 2004, and peaked at 61 per 1,000 hospital births in 2008, but remained higher than 32 per 1,000 through 2016.

The study findings were limited by several factors including potential misclassification of opioid exposure, confounding from other pregnancy exposures, loss of many participants to follow-up, and a lack of generalizability, but the results support the need for additional research, and show that the prevalence of NAS was approximately 10 times the national average in a subset of low-income, urban, minority women, the researchers said.

“However, the effect of opioids is still difficult to disentangle from effects of other childhood exposures. Policy and programmatic efforts to prevent NAS and mitigate its health consequences require more comprehensive longitudinal and intergenerational research,” they concluded.

The study findings contribute to and support the evidence of poor neurodevelopmental and emotional/behavioral outcomes for children with prenatal exposure to opioids or a history of NAS, Susan Brogly, PhD, MSc, noted in an accompanying editorial. Other studies have shown increased risks for visual impairments including strabismus, reduced visual acuity, and delayed visual maturation.

Dr. Brogly, of Queen’s University, Kingston Health Science Center, Ontario, nonetheless noted that a child’s home environment may modify the impact of prenatal opioid exposure or NAS, as evidence has shown that children with in utero heroin exposure have improved outcomes in healthy home environments.

Although the mechanism for how opioid exposure affects development remains uncertain, she suggested that future research should address “interventions to improve health outcomes in this rapidly growing population of children, regardless of the causal mechanism of impairment.”

Dr. Brogly noted that most of the opioid-using mothers in the study by Azuine et al. were unmarried, non-Hispanic white, and multiparous, and had histories of other substance abuse. She emphasized the need for supportive communities for women at risk of opioid use, who also are more likely to have unstable housing situations and histories of sexual and physical abuse.

“The risks of poor pregnancy and child outcomes in cases of maternal opioid exposure are not because of prenatal opioid exposure alone; ongoing difficult social and environmental circumstances have an important role,” and future interventions should address these circumstances to improve long-term health of high-risk women and their children, she emphasized.

The Boston Birth Cohort study is supported in part by grants from the National Institutes of Health and the U.S. Department of Health and Human Services. None of the authors had financial conflicts to disclose.

Dr. Brogly disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development outside the submitted work.

SOURCE: Azuine RE et al. JAMA Network Open. 2019 Jun 28. doi: 10.1001/jamanetworkopen.2019.6405; Brogly S. JAMA Network Open. 2019 Jun 28. doi:10.1001/jamanetworkopen.2019.6428.

SAN FRANCISCO – Type 2 diabetes is much more aggressive in adolescents than in adults, and by the time those with youth-onset diabetes reach their early 20s, they are beset with disease-related complications usually seen in older populations, findings from the RISE and TODAY2 studies have demonstrated.

M. Alexander Otto/Mdedge News

“Additional research is urgently needed to better understand the reasons for this more serious trajectory,” Philip Zeitler, MD, PhD, of Children’s Hospital Colorado, Aurora, said at the annual scientific sessions of the American Diabetes Association. The hope is to identify at-risk children and prevent the disease, but at this point “we don’t know the answer.”

In the meantime, “we are getting more aggressive with bariatric surgery at our center, because nothing else is working as well. It would be nice to move away from that, but these kids are going to die,” he added.

Steven Kahn, MD, of the diabetes Research Center at the University of Washington, Seattle, presented the findings from a comparison of outcomes from the Restoring Insulin Secretion (RISE) studies in adolescents aged 10-19 years and in adults. The RISE Pediatric Medication Study (Diabetes Care. 2018; 41[8]:1717-25) and RISE Adult Medication Study were parallel investigations treatments to preserve or improve beta-cell function.

M. Alexander Otto/MDedge News

“This is the first-ever true comparison of outcomes in youth versus adults,” he said. Both arms had the same design and lab measurements, but the differences in outcomes were “very scary,” he added. “The disease is much more aggressive in youth than in adults.”

Among other things, the RISE youth-versus-adult study compared the outcomes after 3 months of insulin glargine followed by 9 months of metformin, or 12 months of metformin in 132 obese adults and 91 obese adolescents with impaired glucose tolerance or recently diagnosed type 2 diabetes. The treatments were stopped after 12 months, and the participants were reevaluated at 15 months. Hyperglycemic clamps were conducted at baseline, 12 months, and 3 months after treatment cessation (Diabetes. 2019 Jun 9. doi: 10.2337/db19-0299).

In adults, treatment improved insulin sensitivity and beta-cell response, but after treatment cessation, they reverted to baseline by the 15-month evaluation. However, there was no improvement in insulin sensitivity and beta-cell response in adolescents, either during treatment or after cessation, and in fact, they were worse off at 15 months than they had been at baseline, with lower insulin secretion and higher hemoglobin A_1c.

Those stark differences in outcomes between the adolescents and adults were indicative of a more aggressive disease trajectory for younger patients.

Compliance was not the issue, with more than 80% of both adults and children taking more than 80% of their medications, Dr. Kahn said.

He suggested that adolescents might have a different underlying pathology that makes it worse to develop diabetes during puberty, which is already an insulin-resistant state. But, whatever the case, there is an “urgent need” to better understand the differences between adolescents and adults and to find better treatments for younger patients with diabetes, he said.

In regard to using weight loss as a means of treatment or prevention, Dr. Zeitler emphasized that type 2 diabetes in younger patients “occurs in a context of very low socioeconomic status, family dysfunction, and a great deal of stress and [family] illness. It’s often a complex situation and it’s difficult to accomplish effective lifestyle change when families are struggling to have afford quality food, facing challenges of family and neighborhood violence, and working multiple jobs.”

The RISE findings of a more aggressive deterioration in beta-cell function for younger patients were reflected in outcomes in the TODAY2 study, which found that adolescents who are diagnosed with type 2 diabetes face severe renal, cardiovascular, eye, and nerve complications by the time they reach their early 20s.

TODAY2 was an 8-year follow-up to the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial published in 2012 (N Engl J Med. 2012;366:2247-56). Data from the original study of patients aged 10-17 years with type 2 diabetes showed that after a roughly 4-year follow-up, almost half of all participants had experienced loss of glycemic control on their original treatment assignment, a rate much higher than that reported in adults. Metformin plus rosiglitazone was superior to metformin alone in maintaining durable glycemic control and metformin plus an intensive lifestyle intervention was intermediate to the other groups, but not significantly different from them. In addition, metformin alone was found to be least effective in non-Hispanic black patients, metformin and rosiglitazone was most effective in girls.

Overall, 517 participants of the original study’s 669 participants are still being followed as part of the TODAY2 trial. They are managed in community practices now and are in their early 20s, on average.

But, less than 10 years down the road from TODAY, the young adults “have problems you’d expect in your grandparents. Target-organ damage is already evident, and serious cardiovascular events are occurring,” Dr. Zeitler said.
 

Cardiovascular complications

The cardiovascular event rate in TODAY 2 was about the same as is seen in older adults with type 1 diabetes. Overall, there were 38 cardiovascular events in 19 patients for an event rate of 6.4/1,000 patients per year. Those events included heart failure, arrhythmia, coronary artery disease or myocardial infarction, deep venous thrombosis, stroke or transient ischemic attack, and vascular insufficiency.

Over that time, the cumulative incidence of elevated LDL cholesterol increased from 3% in the TODAY report to 26% for TODAY2, and for triglycerides, it went from 18% to 35%. The cumulative incidence of hypertension increased from 19% to 55%.
 

Decline renal function

In regard to renal complications, the cumulative incident curve for microalbuminuria went from 8% at baseline to 40% at 12 years, while macroalbuminuria prevalence increased from 1.5% to 11% during the same time. The cumulative incidence of hyperfiltration increased from 12% to 48%. Risk factors for hyperfiltration included female sex, Hispanic ethnicity, loss of glycemic control, and hypertension, although body mass index was actually associated with lower risk.

So far, there have been four renal events in two patients, who both had chronic kidney disease and end-stage renal failure, for an event rate of 0.7/1,000 patients per year.
 

Pregnancy outcomes

Women in the cohort – about two-thirds of the study population – have had high rates of maternal complications, and their offspring also face complications after birth.

There were 306 pregnancies reported, of which there are known outcomes for 53 (TODAY) and 236 (TODAY2). In all, 5% of the total cohort had voluntary elective termination; 9% and 12% of patients, respectively, suffered a miscarriage before 20 weeks; and 4% of pregnancies in the total cohort ended in stillbirth.

Preterm live births more than doubled from 11% to 24%, and full-term deliveries decreased from 62% to 46% in the TODAY2 patients.

In regard to offspring characteristics, average birth weight in the total cohort was just over 4.5 pounds (national average, 7.3 pounds), and the prevalence of very low birth weight more than doubled from 8% to 16% at the 12-year mark. The prevalence of macrosomia was 19% for the cohort, more than double the national average of 8%. In all, 5% and 7% of offspring were small for gestational age, whereas 22% and 26% of offspring were large for gestational age.

Among other complications, respiratory distress occurred in 8% and 14% of offspring, and cardiac anomalies occurred in 10% and 9%, which, although they held steady across the cohorts, were significantly higher than the national average of 1%. Similarly, neonatal hypoglycemia occurred in 17% and 29% of offspring, again, notably higher than the national average of 2%. Offspring outcomes were worse in mothers with loss of glycemic control.

In regard to maternal pregnancy complications, the rate of hospitalization before delivery increased from 25% to 36%; hypertension increased in prevalence from 19% to 36%; and while macroalbuminuria held steady at 9.4%, microalbuminuria increased from 6% to 8%. Thirty-three percent of the TODAY2 cohort had a hemoglobin A_1c level of more than 8%.
 

Retinopathy

Serious eye problems were common, with notable progression seen in diabetic retinopathy in patients who had fundus photos taken in 2011 (TODAY) and 2018 (TODAY2). Among the patients, 86% and 51%, respectively, of 371 patients had no definitive diabetic retinopathy; 14% and 22% of patients had very mild nonproliferative diabetic retinopathy (NPDR); and 0% and 16% of patients had mild NPDR. None of the TODAY patients had early or high-risk proliferative diabetic retinopathy, compared with 3% and 1%, respectively, in TODAY2. Risk factors included loss of glycemic control (hazard ratio, 19.23; 95% confidence interval, 4.62-80.07).

None of the TODAY patients had macular edema, whereas it occurred in 4% of TODAY2 patients. In all, there were 142 adjudicated eye-related events reported for 92 patients, for an event rate of 15.5/1,000 patients per year. The events included NPDR, proliferative diabetic retinopathy, macular edema, cataracts, glaucoma, and vitreous hemorrhage).
 

Neuropathy

The prevalence of diabetic neuropathy also increased over the duration of follow-up, rising to 28%-33% based on Michigan Neuropathy Screening Instrument scores. There were 14 adjudicated events reported for 12 patients (2.4 events/1,000 patients per year), including peripheral diabetic neuropathy, autonomic neuropathy, and diabetic mononeuropathy.

“We’ve had a number of amputations; quite a number of toes are now missing in this group of kids,” Dr. Zeitler said.

There have been five deaths so far: one heart attack, one renal failure, one overwhelming sepsis, one postop cardiac arrest, and a drug overdose.

Dr. Zeitler was the senior author on 2018 updated ADA guidelines for managing youth-onset type 2 diabetes. The recommendations where extensively shaped by the TODAY findings and were more aggressive than those previously put forward, suggesting, among other things, hemoglobin A_1c targets of 6.5%-7%; earlier treatment with insulin; and stricter management of hypertension, dyslipidemia, and proteinuria (Diabetes Care. 2018;41[12]:2648-68).

The National Institute of Diabetes & Kidney disease funded the studies. The presenters reported no relevant disclosures or conflicts of interest.

[email protected]

This article was updated 7/22/19.

SAN FRANCISCO – Type 2 diabetes is much more aggressive in adolescents than in adults, and by the time those with youth-onset diabetes reach their early 20s, they are beset with disease-related complications usually seen in older populations, findings from the RISE and TODAY2 studies have demonstrated.

M. Alexander Otto/Mdedge News

“Additional research is urgently needed to better understand the reasons for this more serious trajectory,” Philip Zeitler, MD, PhD, of Children’s Hospital Colorado, Aurora, said at the annual scientific sessions of the American Diabetes Association. The hope is to identify at-risk children and prevent the disease, but at this point “we don’t know the answer.”

In the meantime, “we are getting more aggressive with bariatric surgery at our center, because nothing else is working as well. It would be nice to move away from that, but these kids are going to die,” he added.

Steven Kahn, MD, of the diabetes Research Center at the University of Washington, Seattle, presented the findings from a comparison of outcomes from the Restoring Insulin Secretion (RISE) studies in adolescents aged 10-19 years and in adults. The RISE Pediatric Medication Study (Diabetes Care. 2018; 41[8]:1717-25) and RISE Adult Medication Study were parallel investigations treatments to preserve or improve beta-cell function.

M. Alexander Otto/MDedge News

“This is the first-ever true comparison of outcomes in youth versus adults,” he said. Both arms had the same design and lab measurements, but the differences in outcomes were “very scary,” he added. “The disease is much more aggressive in youth than in adults.”

Among other things, the RISE youth-versus-adult study compared the outcomes after 3 months of insulin glargine followed by 9 months of metformin, or 12 months of metformin in 132 obese adults and 91 obese adolescents with impaired glucose tolerance or recently diagnosed type 2 diabetes. The treatments were stopped after 12 months, and the participants were reevaluated at 15 months. Hyperglycemic clamps were conducted at baseline, 12 months, and 3 months after treatment cessation (Diabetes. 2019 Jun 9. doi: 10.2337/db19-0299).

In adults, treatment improved insulin sensitivity and beta-cell response, but after treatment cessation, they reverted to baseline by the 15-month evaluation. However, there was no improvement in insulin sensitivity and beta-cell response in adolescents, either during treatment or after cessation, and in fact, they were worse off at 15 months than they had been at baseline, with lower insulin secretion and higher hemoglobin A_1c.

Those stark differences in outcomes between the adolescents and adults were indicative of a more aggressive disease trajectory for younger patients.

Compliance was not the issue, with more than 80% of both adults and children taking more than 80% of their medications, Dr. Kahn said.

He suggested that adolescents might have a different underlying pathology that makes it worse to develop diabetes during puberty, which is already an insulin-resistant state. But, whatever the case, there is an “urgent need” to better understand the differences between adolescents and adults and to find better treatments for younger patients with diabetes, he said.

In regard to using weight loss as a means of treatment or prevention, Dr. Zeitler emphasized that type 2 diabetes in younger patients “occurs in a context of very low socioeconomic status, family dysfunction, and a great deal of stress and [family] illness. It’s often a complex situation and it’s difficult to accomplish effective lifestyle change when families are struggling to have afford quality food, facing challenges of family and neighborhood violence, and working multiple jobs.”

The RISE findings of a more aggressive deterioration in beta-cell function for younger patients were reflected in outcomes in the TODAY2 study, which found that adolescents who are diagnosed with type 2 diabetes face severe renal, cardiovascular, eye, and nerve complications by the time they reach their early 20s.

TODAY2 was an 8-year follow-up to the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial published in 2012 (N Engl J Med. 2012;366:2247-56). Data from the original study of patients aged 10-17 years with type 2 diabetes showed that after a roughly 4-year follow-up, almost half of all participants had experienced loss of glycemic control on their original treatment assignment, a rate much higher than that reported in adults. Metformin plus rosiglitazone was superior to metformin alone in maintaining durable glycemic control and metformin plus an intensive lifestyle intervention was intermediate to the other groups, but not significantly different from them. In addition, metformin alone was found to be least effective in non-Hispanic black patients, metformin and rosiglitazone was most effective in girls.

Overall, 517 participants of the original study’s 669 participants are still being followed as part of the TODAY2 trial. They are managed in community practices now and are in their early 20s, on average.

But, less than 10 years down the road from TODAY, the young adults “have problems you’d expect in your grandparents. Target-organ damage is already evident, and serious cardiovascular events are occurring,” Dr. Zeitler said.
 

Cardiovascular complications

The cardiovascular event rate in TODAY 2 was about the same as is seen in older adults with type 1 diabetes. Overall, there were 38 cardiovascular events in 19 patients for an event rate of 6.4/1,000 patients per year. Those events included heart failure, arrhythmia, coronary artery disease or myocardial infarction, deep venous thrombosis, stroke or transient ischemic attack, and vascular insufficiency.

Over that time, the cumulative incidence of elevated LDL cholesterol increased from 3% in the TODAY report to 26% for TODAY2, and for triglycerides, it went from 18% to 35%. The cumulative incidence of hypertension increased from 19% to 55%.
 

Decline renal function

In regard to renal complications, the cumulative incident curve for microalbuminuria went from 8% at baseline to 40% at 12 years, while macroalbuminuria prevalence increased from 1.5% to 11% during the same time. The cumulative incidence of hyperfiltration increased from 12% to 48%. Risk factors for hyperfiltration included female sex, Hispanic ethnicity, loss of glycemic control, and hypertension, although body mass index was actually associated with lower risk.

So far, there have been four renal events in two patients, who both had chronic kidney disease and end-stage renal failure, for an event rate of 0.7/1,000 patients per year.
 

Pregnancy outcomes

Women in the cohort – about two-thirds of the study population – have had high rates of maternal complications, and their offspring also face complications after birth.

There were 306 pregnancies reported, of which there are known outcomes for 53 (TODAY) and 236 (TODAY2). In all, 5% of the total cohort had voluntary elective termination; 9% and 12% of patients, respectively, suffered a miscarriage before 20 weeks; and 4% of pregnancies in the total cohort ended in stillbirth.

Preterm live births more than doubled from 11% to 24%, and full-term deliveries decreased from 62% to 46% in the TODAY2 patients.

In regard to offspring characteristics, average birth weight in the total cohort was just over 4.5 pounds (national average, 7.3 pounds), and the prevalence of very low birth weight more than doubled from 8% to 16% at the 12-year mark. The prevalence of macrosomia was 19% for the cohort, more than double the national average of 8%. In all, 5% and 7% of offspring were small for gestational age, whereas 22% and 26% of offspring were large for gestational age.

Among other complications, respiratory distress occurred in 8% and 14% of offspring, and cardiac anomalies occurred in 10% and 9%, which, although they held steady across the cohorts, were significantly higher than the national average of 1%. Similarly, neonatal hypoglycemia occurred in 17% and 29% of offspring, again, notably higher than the national average of 2%. Offspring outcomes were worse in mothers with loss of glycemic control.

In regard to maternal pregnancy complications, the rate of hospitalization before delivery increased from 25% to 36%; hypertension increased in prevalence from 19% to 36%; and while macroalbuminuria held steady at 9.4%, microalbuminuria increased from 6% to 8%. Thirty-three percent of the TODAY2 cohort had a hemoglobin A_1c level of more than 8%.
 

Retinopathy

Serious eye problems were common, with notable progression seen in diabetic retinopathy in patients who had fundus photos taken in 2011 (TODAY) and 2018 (TODAY2). Among the patients, 86% and 51%, respectively, of 371 patients had no definitive diabetic retinopathy; 14% and 22% of patients had very mild nonproliferative diabetic retinopathy (NPDR); and 0% and 16% of patients had mild NPDR. None of the TODAY patients had early or high-risk proliferative diabetic retinopathy, compared with 3% and 1%, respectively, in TODAY2. Risk factors included loss of glycemic control (hazard ratio, 19.23; 95% confidence interval, 4.62-80.07).

None of the TODAY patients had macular edema, whereas it occurred in 4% of TODAY2 patients. In all, there were 142 adjudicated eye-related events reported for 92 patients, for an event rate of 15.5/1,000 patients per year. The events included NPDR, proliferative diabetic retinopathy, macular edema, cataracts, glaucoma, and vitreous hemorrhage).
 

Neuropathy

The prevalence of diabetic neuropathy also increased over the duration of follow-up, rising to 28%-33% based on Michigan Neuropathy Screening Instrument scores. There were 14 adjudicated events reported for 12 patients (2.4 events/1,000 patients per year), including peripheral diabetic neuropathy, autonomic neuropathy, and diabetic mononeuropathy.

“We’ve had a number of amputations; quite a number of toes are now missing in this group of kids,” Dr. Zeitler said.

There have been five deaths so far: one heart attack, one renal failure, one overwhelming sepsis, one postop cardiac arrest, and a drug overdose.

Dr. Zeitler was the senior author on 2018 updated ADA guidelines for managing youth-onset type 2 diabetes. The recommendations where extensively shaped by the TODAY findings and were more aggressive than those previously put forward, suggesting, among other things, hemoglobin A_1c targets of 6.5%-7%; earlier treatment with insulin; and stricter management of hypertension, dyslipidemia, and proteinuria (Diabetes Care. 2018;41[12]:2648-68).

The National Institute of Diabetes & Kidney disease funded the studies. The presenters reported no relevant disclosures or conflicts of interest.

[email protected]

This article was updated 7/22/19.

SAN FRANCISCO – Type 2 diabetes is much more aggressive in adolescents than in adults, and by the time those with youth-onset diabetes reach their early 20s, they are beset with disease-related complications usually seen in older populations, findings from the RISE and TODAY2 studies have demonstrated.

M. Alexander Otto/Mdedge News

“Additional research is urgently needed to better understand the reasons for this more serious trajectory,” Philip Zeitler, MD, PhD, of Children’s Hospital Colorado, Aurora, said at the annual scientific sessions of the American Diabetes Association. The hope is to identify at-risk children and prevent the disease, but at this point “we don’t know the answer.”

In the meantime, “we are getting more aggressive with bariatric surgery at our center, because nothing else is working as well. It would be nice to move away from that, but these kids are going to die,” he added.

Steven Kahn, MD, of the diabetes Research Center at the University of Washington, Seattle, presented the findings from a comparison of outcomes from the Restoring Insulin Secretion (RISE) studies in adolescents aged 10-19 years and in adults. The RISE Pediatric Medication Study (Diabetes Care. 2018; 41[8]:1717-25) and RISE Adult Medication Study were parallel investigations treatments to preserve or improve beta-cell function.

M. Alexander Otto/MDedge News

“This is the first-ever true comparison of outcomes in youth versus adults,” he said. Both arms had the same design and lab measurements, but the differences in outcomes were “very scary,” he added. “The disease is much more aggressive in youth than in adults.”

Among other things, the RISE youth-versus-adult study compared the outcomes after 3 months of insulin glargine followed by 9 months of metformin, or 12 months of metformin in 132 obese adults and 91 obese adolescents with impaired glucose tolerance or recently diagnosed type 2 diabetes. The treatments were stopped after 12 months, and the participants were reevaluated at 15 months. Hyperglycemic clamps were conducted at baseline, 12 months, and 3 months after treatment cessation (Diabetes. 2019 Jun 9. doi: 10.2337/db19-0299).

In adults, treatment improved insulin sensitivity and beta-cell response, but after treatment cessation, they reverted to baseline by the 15-month evaluation. However, there was no improvement in insulin sensitivity and beta-cell response in adolescents, either during treatment or after cessation, and in fact, they were worse off at 15 months than they had been at baseline, with lower insulin secretion and higher hemoglobin A_1c.

Those stark differences in outcomes between the adolescents and adults were indicative of a more aggressive disease trajectory for younger patients.

Compliance was not the issue, with more than 80% of both adults and children taking more than 80% of their medications, Dr. Kahn said.

He suggested that adolescents might have a different underlying pathology that makes it worse to develop diabetes during puberty, which is already an insulin-resistant state. But, whatever the case, there is an “urgent need” to better understand the differences between adolescents and adults and to find better treatments for younger patients with diabetes, he said.

In regard to using weight loss as a means of treatment or prevention, Dr. Zeitler emphasized that type 2 diabetes in younger patients “occurs in a context of very low socioeconomic status, family dysfunction, and a great deal of stress and [family] illness. It’s often a complex situation and it’s difficult to accomplish effective lifestyle change when families are struggling to have afford quality food, facing challenges of family and neighborhood violence, and working multiple jobs.”

The RISE findings of a more aggressive deterioration in beta-cell function for younger patients were reflected in outcomes in the TODAY2 study, which found that adolescents who are diagnosed with type 2 diabetes face severe renal, cardiovascular, eye, and nerve complications by the time they reach their early 20s.

TODAY2 was an 8-year follow-up to the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial published in 2012 (N Engl J Med. 2012;366:2247-56). Data from the original study of patients aged 10-17 years with type 2 diabetes showed that after a roughly 4-year follow-up, almost half of all participants had experienced loss of glycemic control on their original treatment assignment, a rate much higher than that reported in adults. Metformin plus rosiglitazone was superior to metformin alone in maintaining durable glycemic control and metformin plus an intensive lifestyle intervention was intermediate to the other groups, but not significantly different from them. In addition, metformin alone was found to be least effective in non-Hispanic black patients, metformin and rosiglitazone was most effective in girls.

Overall, 517 participants of the original study’s 669 participants are still being followed as part of the TODAY2 trial. They are managed in community practices now and are in their early 20s, on average.

But, less than 10 years down the road from TODAY, the young adults “have problems you’d expect in your grandparents. Target-organ damage is already evident, and serious cardiovascular events are occurring,” Dr. Zeitler said.
 

Cardiovascular complications

The cardiovascular event rate in TODAY 2 was about the same as is seen in older adults with type 1 diabetes. Overall, there were 38 cardiovascular events in 19 patients for an event rate of 6.4/1,000 patients per year. Those events included heart failure, arrhythmia, coronary artery disease or myocardial infarction, deep venous thrombosis, stroke or transient ischemic attack, and vascular insufficiency.

Over that time, the cumulative incidence of elevated LDL cholesterol increased from 3% in the TODAY report to 26% for TODAY2, and for triglycerides, it went from 18% to 35%. The cumulative incidence of hypertension increased from 19% to 55%.
 

Decline renal function

In regard to renal complications, the cumulative incident curve for microalbuminuria went from 8% at baseline to 40% at 12 years, while macroalbuminuria prevalence increased from 1.5% to 11% during the same time. The cumulative incidence of hyperfiltration increased from 12% to 48%. Risk factors for hyperfiltration included female sex, Hispanic ethnicity, loss of glycemic control, and hypertension, although body mass index was actually associated with lower risk.

So far, there have been four renal events in two patients, who both had chronic kidney disease and end-stage renal failure, for an event rate of 0.7/1,000 patients per year.
 

Pregnancy outcomes

Women in the cohort – about two-thirds of the study population – have had high rates of maternal complications, and their offspring also face complications after birth.

There were 306 pregnancies reported, of which there are known outcomes for 53 (TODAY) and 236 (TODAY2). In all, 5% of the total cohort had voluntary elective termination; 9% and 12% of patients, respectively, suffered a miscarriage before 20 weeks; and 4% of pregnancies in the total cohort ended in stillbirth.

Preterm live births more than doubled from 11% to 24%, and full-term deliveries decreased from 62% to 46% in the TODAY2 patients.

In regard to offspring characteristics, average birth weight in the total cohort was just over 4.5 pounds (national average, 7.3 pounds), and the prevalence of very low birth weight more than doubled from 8% to 16% at the 12-year mark. The prevalence of macrosomia was 19% for the cohort, more than double the national average of 8%. In all, 5% and 7% of offspring were small for gestational age, whereas 22% and 26% of offspring were large for gestational age.

Among other complications, respiratory distress occurred in 8% and 14% of offspring, and cardiac anomalies occurred in 10% and 9%, which, although they held steady across the cohorts, were significantly higher than the national average of 1%. Similarly, neonatal hypoglycemia occurred in 17% and 29% of offspring, again, notably higher than the national average of 2%. Offspring outcomes were worse in mothers with loss of glycemic control.

In regard to maternal pregnancy complications, the rate of hospitalization before delivery increased from 25% to 36%; hypertension increased in prevalence from 19% to 36%; and while macroalbuminuria held steady at 9.4%, microalbuminuria increased from 6% to 8%. Thirty-three percent of the TODAY2 cohort had a hemoglobin A_1c level of more than 8%.
 

Retinopathy

Serious eye problems were common, with notable progression seen in diabetic retinopathy in patients who had fundus photos taken in 2011 (TODAY) and 2018 (TODAY2). Among the patients, 86% and 51%, respectively, of 371 patients had no definitive diabetic retinopathy; 14% and 22% of patients had very mild nonproliferative diabetic retinopathy (NPDR); and 0% and 16% of patients had mild NPDR. None of the TODAY patients had early or high-risk proliferative diabetic retinopathy, compared with 3% and 1%, respectively, in TODAY2. Risk factors included loss of glycemic control (hazard ratio, 19.23; 95% confidence interval, 4.62-80.07).

None of the TODAY patients had macular edema, whereas it occurred in 4% of TODAY2 patients. In all, there were 142 adjudicated eye-related events reported for 92 patients, for an event rate of 15.5/1,000 patients per year. The events included NPDR, proliferative diabetic retinopathy, macular edema, cataracts, glaucoma, and vitreous hemorrhage).
 

Neuropathy

The prevalence of diabetic neuropathy also increased over the duration of follow-up, rising to 28%-33% based on Michigan Neuropathy Screening Instrument scores. There were 14 adjudicated events reported for 12 patients (2.4 events/1,000 patients per year), including peripheral diabetic neuropathy, autonomic neuropathy, and diabetic mononeuropathy.

“We’ve had a number of amputations; quite a number of toes are now missing in this group of kids,” Dr. Zeitler said.

There have been five deaths so far: one heart attack, one renal failure, one overwhelming sepsis, one postop cardiac arrest, and a drug overdose.

Dr. Zeitler was the senior author on 2018 updated ADA guidelines for managing youth-onset type 2 diabetes. The recommendations where extensively shaped by the TODAY findings and were more aggressive than those previously put forward, suggesting, among other things, hemoglobin A_1c targets of 6.5%-7%; earlier treatment with insulin; and stricter management of hypertension, dyslipidemia, and proteinuria (Diabetes Care. 2018;41[12]:2648-68).

The National Institute of Diabetes & Kidney disease funded the studies. The presenters reported no relevant disclosures or conflicts of interest.

[email protected]

This article was updated 7/22/19.

Prolonged labor can result in hyponatremia, a case series showed.

dimarik/iStock/Getty Images

Sarah C. Lassey, MD, of the Brigham and Women’s Hospital, Boston, and colleagues noted that a rise in the number of women choosing a home labor means health care professionals may be more likely to encounter patients with hyponatremia secondary to prolonged labor and excessive hypotonic fluid consumption.

They presented the cases of two patients who were transferred to their labor and delivery unit with hyponatremia after a prolonged labor, published in Obstetrics & Gynecology. One woman presented with somnolence and confusion. The other woman was alert on arrival, but post partum had slurred speech and blurry vision.

“A likely mechanism for hyponatremia in these cases includes endogenous oxytocin and excessive free water consumption in the setting of hypovolemia,” they suggested.

One of the patients was managed with an intravenous infusion of normal saline and went on to make a full recovery after being monitored in the intensive care unit.

The other patient also was managed with normal saline, but her serum sodium level rose by 6 mmol/L within 3 hours of delivery, raising concern that the serum sodium correction was dangerously rapid. After consultation with a nephrologist, the patient’s saline IV was discontinued, and she was given desmopressin acetate to “reduce rapid diuresis of free water excretion,” they said.

“The goal of treatment should be to raise the serum sodium concentration by 1-2 mmol/L per hour, with a maximum increase ranging from 8 mmol/L in 24 hours to 25 mmol/L in 48 hours,” Dr. Lassey and colleagues noted. “The risk of raising the serum sodium concentration too quickly is osmotic demyelination syndrome, which has been reported with a serum sodium level increase of more than 12 mmol/L in 24 hours.”

Hyponatremia should be considered in women presenting as home birth transfers and in women undergoing prolonged labor at the hospital, they concluded. It also makes sense to perform electrolyte testing on admission for women with a long labor prior to coming to the hospital and for those whose labor becomes prolonged who drink a lot of fluids.

Considering the risks associated with hyponatremia, if suspicion is high, it may be prudent to start isotonic fluids before lab results are back, they said. Symptoms of mild hyponatremia include headache, lethargy, nausea, vomiting, and anorexia. Moderate hyponatremia can present as agitation, disorientation, and psychosis; if severe, hyponatremia may present as seizure, coma, or death.

Also alert your neonatal colleagues in cases of maternal intrapartum hyponatremia, because “neonatal serum sodium level will be reflective of the mother’s serum sodium level,” Dr. Lassey and associates added.

Dr. Daniela Carusi received payment from UptoDate. The other authors did not report any potential conflicts of interest.

SOURCE: Lassey SC et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003306.

Prolonged labor can result in hyponatremia, a case series showed.

dimarik/iStock/Getty Images

Sarah C. Lassey, MD, of the Brigham and Women’s Hospital, Boston, and colleagues noted that a rise in the number of women choosing a home labor means health care professionals may be more likely to encounter patients with hyponatremia secondary to prolonged labor and excessive hypotonic fluid consumption.

They presented the cases of two patients who were transferred to their labor and delivery unit with hyponatremia after a prolonged labor, published in Obstetrics & Gynecology. One woman presented with somnolence and confusion. The other woman was alert on arrival, but post partum had slurred speech and blurry vision.

“A likely mechanism for hyponatremia in these cases includes endogenous oxytocin and excessive free water consumption in the setting of hypovolemia,” they suggested.

One of the patients was managed with an intravenous infusion of normal saline and went on to make a full recovery after being monitored in the intensive care unit.

The other patient also was managed with normal saline, but her serum sodium level rose by 6 mmol/L within 3 hours of delivery, raising concern that the serum sodium correction was dangerously rapid. After consultation with a nephrologist, the patient’s saline IV was discontinued, and she was given desmopressin acetate to “reduce rapid diuresis of free water excretion,” they said.

“The goal of treatment should be to raise the serum sodium concentration by 1-2 mmol/L per hour, with a maximum increase ranging from 8 mmol/L in 24 hours to 25 mmol/L in 48 hours,” Dr. Lassey and colleagues noted. “The risk of raising the serum sodium concentration too quickly is osmotic demyelination syndrome, which has been reported with a serum sodium level increase of more than 12 mmol/L in 24 hours.”

Hyponatremia should be considered in women presenting as home birth transfers and in women undergoing prolonged labor at the hospital, they concluded. It also makes sense to perform electrolyte testing on admission for women with a long labor prior to coming to the hospital and for those whose labor becomes prolonged who drink a lot of fluids.

Considering the risks associated with hyponatremia, if suspicion is high, it may be prudent to start isotonic fluids before lab results are back, they said. Symptoms of mild hyponatremia include headache, lethargy, nausea, vomiting, and anorexia. Moderate hyponatremia can present as agitation, disorientation, and psychosis; if severe, hyponatremia may present as seizure, coma, or death.

Also alert your neonatal colleagues in cases of maternal intrapartum hyponatremia, because “neonatal serum sodium level will be reflective of the mother’s serum sodium level,” Dr. Lassey and associates added.

Dr. Daniela Carusi received payment from UptoDate. The other authors did not report any potential conflicts of interest.

SOURCE: Lassey SC et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003306.

Prolonged labor can result in hyponatremia, a case series showed.

dimarik/iStock/Getty Images

Sarah C. Lassey, MD, of the Brigham and Women’s Hospital, Boston, and colleagues noted that a rise in the number of women choosing a home labor means health care professionals may be more likely to encounter patients with hyponatremia secondary to prolonged labor and excessive hypotonic fluid consumption.

They presented the cases of two patients who were transferred to their labor and delivery unit with hyponatremia after a prolonged labor, published in Obstetrics & Gynecology. One woman presented with somnolence and confusion. The other woman was alert on arrival, but post partum had slurred speech and blurry vision.

“A likely mechanism for hyponatremia in these cases includes endogenous oxytocin and excessive free water consumption in the setting of hypovolemia,” they suggested.

One of the patients was managed with an intravenous infusion of normal saline and went on to make a full recovery after being monitored in the intensive care unit.

The other patient also was managed with normal saline, but her serum sodium level rose by 6 mmol/L within 3 hours of delivery, raising concern that the serum sodium correction was dangerously rapid. After consultation with a nephrologist, the patient’s saline IV was discontinued, and she was given desmopressin acetate to “reduce rapid diuresis of free water excretion,” they said.

“The goal of treatment should be to raise the serum sodium concentration by 1-2 mmol/L per hour, with a maximum increase ranging from 8 mmol/L in 24 hours to 25 mmol/L in 48 hours,” Dr. Lassey and colleagues noted. “The risk of raising the serum sodium concentration too quickly is osmotic demyelination syndrome, which has been reported with a serum sodium level increase of more than 12 mmol/L in 24 hours.”

Hyponatremia should be considered in women presenting as home birth transfers and in women undergoing prolonged labor at the hospital, they concluded. It also makes sense to perform electrolyte testing on admission for women with a long labor prior to coming to the hospital and for those whose labor becomes prolonged who drink a lot of fluids.

Considering the risks associated with hyponatremia, if suspicion is high, it may be prudent to start isotonic fluids before lab results are back, they said. Symptoms of mild hyponatremia include headache, lethargy, nausea, vomiting, and anorexia. Moderate hyponatremia can present as agitation, disorientation, and psychosis; if severe, hyponatremia may present as seizure, coma, or death.

Also alert your neonatal colleagues in cases of maternal intrapartum hyponatremia, because “neonatal serum sodium level will be reflective of the mother’s serum sodium level,” Dr. Lassey and associates added.

Dr. Daniela Carusi received payment from UptoDate. The other authors did not report any potential conflicts of interest.

SOURCE: Lassey SC et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003306.

NASHVILLE, TENN. – Opportunistic bilateral salpingectomy is gaining favor as an approach to sterilization, including in the vaginal delivery setting.

Sharon Worcester/MDedge News

“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.

For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.

“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.

ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”

“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).

Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Opportunistic bilateral salpingectomy is gaining favor as an approach to sterilization, including in the vaginal delivery setting.

Sharon Worcester/MDedge News

“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.

For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.

“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.

ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”

“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).

Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”

Dr. Espey reported having no relevant financial disclosures.

[email protected]

NASHVILLE, TENN. – Opportunistic bilateral salpingectomy is gaining favor as an approach to sterilization, including in the vaginal delivery setting.

Sharon Worcester/MDedge News

“[It is] probably the newest thing on the block ... this is becoming super widespread,” Eve Espey, MD, said of the procedure during a contraceptive update at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Although evidence directly supporting bilateral salpingectomy for sterilization is lacking, there are good reasons to consider it, she said.

For example, the procedure is likely more effective than tubal ligation with no increased risk for complications, and is probably more likely to cut ovarian cancer risk than is tubal ligation, explained Dr. Espey, professor and chair of the department of obstetrics and gynecology and director of the family planning fellowship at the University of New Mexico, Albuquerque.

“So we don’t actually have good [randomized controlled trials] on effectiveness for [bilateral] salpingectomy, but it is most like a partial salpingectomy, which is highly effective, so there is reason to believe that it might be more effective,” she added. The downsides are that the procedure may take longer, it may impair ovarian blood supply, and long-term population-level data on outcomes are lacking.

ACOG said in a 2015 committee opinion that when counseling women, bilateral salpingectomy can be discussed and considered “a method that provides effective contraception,” but also stressed the need for randomized controlled trials to support any related reduction in ovarian cancer risk. That opinion (#620) was replaced in April 2019 by Committee Opinion #774, which addresses opportunistic salpingectomy for epithelial ovarian cancer prevention, and which states that “the risks and benefits of salpingectomy should be discussed with patients who desire permanent sterilization.”

“[The Society of Gynecologic Oncology] is much, much more emphatic,” Dr. Espey said, citing a 2013 Clinical Practice Statement calling for discussion and consideration of risk-reducing salpingectomy in lieu of tubal ligation for women at average risk of ovarian cancer (after childbearing).

Dr. Espey also noted that during a recent grand rounds on sterilization, about 90% of participants said they were doing bilateral salpingectomy in the setting of vaginal delivery. “So I think we’re going to see this coming not just with C-section, but also with vaginal delivery.”

Dr. Espey reported having no relevant financial disclosures.

[email protected]

Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.

Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.

Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

Pregnancy management and outcomes have improved markedly for women with SLE over the past 2 decades, but there’s still progress to be made, research shows.

A retrospective cohort study led by rheumatologist Bella Mehta, MBBS, of the Hospital for Special Surgery in New York, and colleagues looked at data from the National Inpatient Sample database involving 93,820 pregnant women with SLE and 78,045,054 without SLE who were hospitalized in the United States between 1998 and 2015.

The results showed that over the 18-year study period, in-hospital maternal deaths per 100,000 admissions declined among patients with as well as those without SLE (442 vs. 13 for 1998-2000 and less than 50 vs. 10 for 2013-2015), although the decrease was greater in women with SLE (difference in trends, P less than .002).

Fetal mortality declined both for patients with SLE (268 deaths per 10,000 deliveries in 1998-2000 vs. 153 in 2013-2015) and those without SLE (72 deaths per 10,000 deliveries in 1998-2000 vs. 66 in 2013-2015).

“Although the decrease in fetal mortality seems somewhat greater in patients with SLE than those without it, the difference in trends is not statistically significant (P = .064),” the study authors noted in their paper, published in Annals of Internal Medicine.

Although patients with SLE in their study showed greater progress in rates of preeclampsia or eclampsia and length of stay, they still had worse outcomes in all measures when compared against women without SLE, the authors noted.

“Our study provides nationwide evidence that SLE pregnancy outcomes have become markedly better in the past 2 decades and continue to improve. However, SLE pregnancy risks remain high, and more work is needed to ensure good pregnancy outcomes among women with SLE,” they concluded.

Writing in an accompanying editorial, Megan E.B. Clowse, MD, of Duke University, Durham, N.C., noted that although the study findings of a progressive reduction in maternal mortality seemed very likely, the absolute decrease seen – from 140 maternal deaths per 100,000 births to fewer than 50 in 2013-2015 – warranted some reflection (Ann Intern Med. 2019;171:212-3. doi: 10.7326/M19-1667).

“SLE pregnancy management has not advanced within the past 5 years to an extent great enough to explain such a large drop in mortality,” she wrote.

There were also question marks around whether the NIS data should be used to analyze very rare events, such as maternal deaths in women with SLE. The SLE diagnosis in the database may also have included pregnancies in women who did not have SLE but instead had an elevated level of antinuclear antibody or lupus anticoagulant, which “may have diluted the frequency of poor outcomes,” Dr. Clowse wrote.

“For these reasons, I am concerned that the observed decline in maternal mortality may be an artifact, underestimating the ongoing risk of pregnancy for women with SLE,” Dr. Clowse wrote.

She added that recent analyses demonstrated that the use of hydroxychloroquine and aspirin in SLE pregnancy was not widespread.

“The inaugural reproductive health guidelines soon to be published by the American College of Rheumatology will have the potential to help expand state-of-the-art approaches to the management of pregnant women with SLE seen in everyday practice,” she concluded.

The study had no primary funding source and no conflicts of interest were declared. Dr. Mehta is supported by the C. Ronald MacKenzie Young Scientist Endowment Award. Dr. Clowse reported grants from GlaxoSmithKline and personal fees from UCB, both outside the submitted work.

SOURCE: Mehta B et al. Ann Intern Med. 2019;171:164-71. doi: 10.7326/M19-0120.

Using a split dose of oral oxycodone after cesarean delivery could more than halve opioid use, according to a study published in Obstetrics & Gynecology.

©joruba/Thinkstock

A retrospective study reviewed medical records of 1,050 women undergoing cesarean delivery, 508 of whom were treated after a change in protocol for postdelivery oxycodone orders. Instead of a 5-mg oral dose given for a verbal pain score of 4/10 or below and 10 mg for a pain score of 5-10/10, patients were given 2.5-mg or 5-mg dose respectively, with a nurse check after 1 hour to see if more of the same dosage was needed.

The split-dose approach was associated with a 56% reduction in median opioid consumption in the first 48 hours after cesarean delivery; 10 mg before the change in practice to 4.4 mg after it. There was also a 6.9-percentage-point decrease in the number of patients needing any postoperative opioids.

While the study did show a slight increase in average verbal pain scores in the first 58 hours after surgery – from a mean of 1.8 before the split-dose protocol was introduced to 2 after it was introduced – there was no increase in the use of nonsteroidal anti-inflammatory drugs, acetaminophen, or gabapentin, and no difference in peak verbal pain scores.

“Our goal with the introduction of this new order set was to use a patient-centered, response-feedback approach to postcesarean delivery analgesia in the form of split doses of oxycodone rather than the traditional standard dose model,” wrote Jalal A. Nanji, MD, of the department of anesthesiology and pain medicine at the University of Alberta, Edmonton, and coauthors. “Involving patients in the decision for how much postcesarean delivery analgesia they will receive has been found to reduce opioid use and improve maternal satisfaction.”

The number of patients reporting postoperative nausea or vomiting was halved in those treated with the split-dose regimen, with no difference in mean overall patient satisfaction score.

Dr. Nanji and associates wrote that women viewed avoiding nausea or vomiting after a cesarean as a high priority, and targeting the root cause – excessive opioid use – was preferable to treating nausea and vomiting with antiemetics.

They also noted that input from nursing staff was vital in developing the new split-order set, not only because it directly affected nursing work flow but also to optimize the process.

“With the opioid epidemic on the rise and the increase in efforts by physicians to decrease outpatient opioid prescriptions, this study is extremely relevant and timely,” commented Marissa Platner, MD, an assistant professor in maternal-fetal medicine at Emory University, Atlanta.

“Although this study is retrospective and, therefore, there are inherent biases and an inability to control all contributing factors, it clearly demonstrates that, overall, there seem to be improved outcomes with split-dose protocol of opioid administration during the postoperative period in terms of overall patient satisfaction, opioid consumption, and postoperative nausea and vomiting. The patient-centered nature and response-feedback design of this study also contributes to its strength and improves its generalizability. In order to encourage others to considering adapting protocol in other institutions, it should be evaluated via a randomized controlled trial," Dr. Platner said in an interview.* 

"The premise and execution of this study were novel and interesting," commented Katrina Mark, MD, associate professor of obstetrics, gynecology & reproductive sciences at the University of Maryland School of Medicine. "The authors found that by decreasing the standard doses of oxycodone ordered after a cesarean section and asking women if they desired better pain control, rather than reacting only to a pain score, patients’ overall postoperative usage of opiates also decreased. In decreasing the amount of opiates used, the authors also observed a decrease some of the side effects associated with opiate use, which is promising.

"This study, among other recent studies, highlights the fact that postoperative prescribing standards are not evidence-based and may lead to overprescribing of opiates. Improving prescribing practices is a noble and important goal. In this study, a change in clinical practice among both nurses and prescribers is likely what caused the greatest change. The use of a protocol which prescribed oxycodone based on asking if a woman desired improved pain control, rather than prescribing only based on her pain score response, makes a lot of intuitive sense. Decreasing opioid consumption requires education of healthcare providers and patients, and protocols like this one will help to encourage that conversation," she noted in an interview.

"Before the findings of this study can be widely adopted, however, there are two major points that will need to be addressed," Dr. Mark emphasized. "The first is patient satisfaction. The peak pain scores were not different between the groups, but the mean pain scores were. The authors deemed this clinically insignificant, which it may be. However, without the patients’ perspective on this new protocol, it is difficult to tell if the opioid usage decreased because women actually needed less opiates or if it decreased because the system discouraged opioid use and made it more challenging for them to obtain the medicine they needed to achieve adequate pain control. The desire to decrease opioid prescribing is warranted, and likely completely appropriate, but there is certainly a role for opioids in pain management. We should not be so motivated to decrease use that we cause unnecessary suffering. The second point that will need to be addressed is the effect on nursing practice. There was no standardized evaluation of the impact that this protocol had on the nursing staff, and it is unclear if this protocol would require greater resources than may be readily available at all hospitals."**

The study was supported by the department of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. One author declared travel funding from a university. No other conflicts of interest were declared. Dr. Platner and Dr. Mark also had no relevant financial disclosures.*

SOURCE: Nanji J et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003305.

*This article was updated on 7/15/2019.

**It was updated again on 7/17/2019.

Using a split dose of oral oxycodone after cesarean delivery could more than halve opioid use, according to a study published in Obstetrics & Gynecology.

©joruba/Thinkstock

A retrospective study reviewed medical records of 1,050 women undergoing cesarean delivery, 508 of whom were treated after a change in protocol for postdelivery oxycodone orders. Instead of a 5-mg oral dose given for a verbal pain score of 4/10 or below and 10 mg for a pain score of 5-10/10, patients were given 2.5-mg or 5-mg dose respectively, with a nurse check after 1 hour to see if more of the same dosage was needed.

The split-dose approach was associated with a 56% reduction in median opioid consumption in the first 48 hours after cesarean delivery; 10 mg before the change in practice to 4.4 mg after it. There was also a 6.9-percentage-point decrease in the number of patients needing any postoperative opioids.

While the study did show a slight increase in average verbal pain scores in the first 58 hours after surgery – from a mean of 1.8 before the split-dose protocol was introduced to 2 after it was introduced – there was no increase in the use of nonsteroidal anti-inflammatory drugs, acetaminophen, or gabapentin, and no difference in peak verbal pain scores.

“Our goal with the introduction of this new order set was to use a patient-centered, response-feedback approach to postcesarean delivery analgesia in the form of split doses of oxycodone rather than the traditional standard dose model,” wrote Jalal A. Nanji, MD, of the department of anesthesiology and pain medicine at the University of Alberta, Edmonton, and coauthors. “Involving patients in the decision for how much postcesarean delivery analgesia they will receive has been found to reduce opioid use and improve maternal satisfaction.”

The number of patients reporting postoperative nausea or vomiting was halved in those treated with the split-dose regimen, with no difference in mean overall patient satisfaction score.

Dr. Nanji and associates wrote that women viewed avoiding nausea or vomiting after a cesarean as a high priority, and targeting the root cause – excessive opioid use – was preferable to treating nausea and vomiting with antiemetics.

They also noted that input from nursing staff was vital in developing the new split-order set, not only because it directly affected nursing work flow but also to optimize the process.

“With the opioid epidemic on the rise and the increase in efforts by physicians to decrease outpatient opioid prescriptions, this study is extremely relevant and timely,” commented Marissa Platner, MD, an assistant professor in maternal-fetal medicine at Emory University, Atlanta.

“Although this study is retrospective and, therefore, there are inherent biases and an inability to control all contributing factors, it clearly demonstrates that, overall, there seem to be improved outcomes with split-dose protocol of opioid administration during the postoperative period in terms of overall patient satisfaction, opioid consumption, and postoperative nausea and vomiting. The patient-centered nature and response-feedback design of this study also contributes to its strength and improves its generalizability. In order to encourage others to considering adapting protocol in other institutions, it should be evaluated via a randomized controlled trial," Dr. Platner said in an interview.* 

"The premise and execution of this study were novel and interesting," commented Katrina Mark, MD, associate professor of obstetrics, gynecology & reproductive sciences at the University of Maryland School of Medicine. "The authors found that by decreasing the standard doses of oxycodone ordered after a cesarean section and asking women if they desired better pain control, rather than reacting only to a pain score, patients’ overall postoperative usage of opiates also decreased. In decreasing the amount of opiates used, the authors also observed a decrease some of the side effects associated with opiate use, which is promising.

"This study, among other recent studies, highlights the fact that postoperative prescribing standards are not evidence-based and may lead to overprescribing of opiates. Improving prescribing practices is a noble and important goal. In this study, a change in clinical practice among both nurses and prescribers is likely what caused the greatest change. The use of a protocol which prescribed oxycodone based on asking if a woman desired improved pain control, rather than prescribing only based on her pain score response, makes a lot of intuitive sense. Decreasing opioid consumption requires education of healthcare providers and patients, and protocols like this one will help to encourage that conversation," she noted in an interview.

"Before the findings of this study can be widely adopted, however, there are two major points that will need to be addressed," Dr. Mark emphasized. "The first is patient satisfaction. The peak pain scores were not different between the groups, but the mean pain scores were. The authors deemed this clinically insignificant, which it may be. However, without the patients’ perspective on this new protocol, it is difficult to tell if the opioid usage decreased because women actually needed less opiates or if it decreased because the system discouraged opioid use and made it more challenging for them to obtain the medicine they needed to achieve adequate pain control. The desire to decrease opioid prescribing is warranted, and likely completely appropriate, but there is certainly a role for opioids in pain management. We should not be so motivated to decrease use that we cause unnecessary suffering. The second point that will need to be addressed is the effect on nursing practice. There was no standardized evaluation of the impact that this protocol had on the nursing staff, and it is unclear if this protocol would require greater resources than may be readily available at all hospitals."**

The study was supported by the department of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. One author declared travel funding from a university. No other conflicts of interest were declared. Dr. Platner and Dr. Mark also had no relevant financial disclosures.*

SOURCE: Nanji J et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003305.

*This article was updated on 7/15/2019.

**It was updated again on 7/17/2019.

Using a split dose of oral oxycodone after cesarean delivery could more than halve opioid use, according to a study published in Obstetrics & Gynecology.

©joruba/Thinkstock

A retrospective study reviewed medical records of 1,050 women undergoing cesarean delivery, 508 of whom were treated after a change in protocol for postdelivery oxycodone orders. Instead of a 5-mg oral dose given for a verbal pain score of 4/10 or below and 10 mg for a pain score of 5-10/10, patients were given 2.5-mg or 5-mg dose respectively, with a nurse check after 1 hour to see if more of the same dosage was needed.

The split-dose approach was associated with a 56% reduction in median opioid consumption in the first 48 hours after cesarean delivery; 10 mg before the change in practice to 4.4 mg after it. There was also a 6.9-percentage-point decrease in the number of patients needing any postoperative opioids.

While the study did show a slight increase in average verbal pain scores in the first 58 hours after surgery – from a mean of 1.8 before the split-dose protocol was introduced to 2 after it was introduced – there was no increase in the use of nonsteroidal anti-inflammatory drugs, acetaminophen, or gabapentin, and no difference in peak verbal pain scores.

“Our goal with the introduction of this new order set was to use a patient-centered, response-feedback approach to postcesarean delivery analgesia in the form of split doses of oxycodone rather than the traditional standard dose model,” wrote Jalal A. Nanji, MD, of the department of anesthesiology and pain medicine at the University of Alberta, Edmonton, and coauthors. “Involving patients in the decision for how much postcesarean delivery analgesia they will receive has been found to reduce opioid use and improve maternal satisfaction.”

The number of patients reporting postoperative nausea or vomiting was halved in those treated with the split-dose regimen, with no difference in mean overall patient satisfaction score.

Dr. Nanji and associates wrote that women viewed avoiding nausea or vomiting after a cesarean as a high priority, and targeting the root cause – excessive opioid use – was preferable to treating nausea and vomiting with antiemetics.

They also noted that input from nursing staff was vital in developing the new split-order set, not only because it directly affected nursing work flow but also to optimize the process.

“With the opioid epidemic on the rise and the increase in efforts by physicians to decrease outpatient opioid prescriptions, this study is extremely relevant and timely,” commented Marissa Platner, MD, an assistant professor in maternal-fetal medicine at Emory University, Atlanta.

“Although this study is retrospective and, therefore, there are inherent biases and an inability to control all contributing factors, it clearly demonstrates that, overall, there seem to be improved outcomes with split-dose protocol of opioid administration during the postoperative period in terms of overall patient satisfaction, opioid consumption, and postoperative nausea and vomiting. The patient-centered nature and response-feedback design of this study also contributes to its strength and improves its generalizability. In order to encourage others to considering adapting protocol in other institutions, it should be evaluated via a randomized controlled trial," Dr. Platner said in an interview.* 

"The premise and execution of this study were novel and interesting," commented Katrina Mark, MD, associate professor of obstetrics, gynecology & reproductive sciences at the University of Maryland School of Medicine. "The authors found that by decreasing the standard doses of oxycodone ordered after a cesarean section and asking women if they desired better pain control, rather than reacting only to a pain score, patients’ overall postoperative usage of opiates also decreased. In decreasing the amount of opiates used, the authors also observed a decrease some of the side effects associated with opiate use, which is promising.

"This study, among other recent studies, highlights the fact that postoperative prescribing standards are not evidence-based and may lead to overprescribing of opiates. Improving prescribing practices is a noble and important goal. In this study, a change in clinical practice among both nurses and prescribers is likely what caused the greatest change. The use of a protocol which prescribed oxycodone based on asking if a woman desired improved pain control, rather than prescribing only based on her pain score response, makes a lot of intuitive sense. Decreasing opioid consumption requires education of healthcare providers and patients, and protocols like this one will help to encourage that conversation," she noted in an interview.

"Before the findings of this study can be widely adopted, however, there are two major points that will need to be addressed," Dr. Mark emphasized. "The first is patient satisfaction. The peak pain scores were not different between the groups, but the mean pain scores were. The authors deemed this clinically insignificant, which it may be. However, without the patients’ perspective on this new protocol, it is difficult to tell if the opioid usage decreased because women actually needed less opiates or if it decreased because the system discouraged opioid use and made it more challenging for them to obtain the medicine they needed to achieve adequate pain control. The desire to decrease opioid prescribing is warranted, and likely completely appropriate, but there is certainly a role for opioids in pain management. We should not be so motivated to decrease use that we cause unnecessary suffering. The second point that will need to be addressed is the effect on nursing practice. There was no standardized evaluation of the impact that this protocol had on the nursing staff, and it is unclear if this protocol would require greater resources than may be readily available at all hospitals."**

The study was supported by the department of anesthesiology, perioperative, and pain medicine at Stanford (Calif.) University. One author declared travel funding from a university. No other conflicts of interest were declared. Dr. Platner and Dr. Mark also had no relevant financial disclosures.*

SOURCE: Nanji J et al. Obstet Gynecol. 2019. doi: 10.1097/AOG.0000000000003305.

*This article was updated on 7/15/2019.

**It was updated again on 7/17/2019.