User login
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
FROM JAMA
Key clinical point:
Major finding: With a threshold of transvaginal cervical length of 25 mm or less at 16-22 weeks’ gestation, 247 women would need to be screened to identify one case of spontaneous preterm birth before 37 weeks’ gestation.
Data source: A prospective multicenter observational cohort study involving 9,410 nulliparous women across the United States.
Disclosures: The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. An associate reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.