Cerclage plus Adjuvant Vaginal Progesterone for Preterm Birth Prevention in Patients with a Short or Dilated Cervix without Prior Preterm Birth.

OBJECTIVE: The primary objective was to determine if vaginal progesterone following cerclage for cervical length <10 mm or cervical dilation in patients without a history of spontaneous preterm birth (sPTB) decreased the risk of preterm birth at <34 weeks' gestation compared with cerclage alone. Secondary objectives were to determine if vaginal progesterone following cerclage (1) decreased the risk of preterm birth at <24, <28, and <37 weeks' gestation and (2) increased the latency period from cerclage placement to delivery compared with treatment with cerclage alone. STUDY DESIGN: Multicenter retrospective cohort study from 2015 to 2020 of singleton pregnancies, without prior sPTB, who had cerclage placement <24 weeks' gestation for cervical length <10 mm or cervical dilation. Exposure defined as cerclage plus vaginal progesterone postoperatively (dual therapy) and unexposed as cerclage alone (monotherapy), based on surgeon preference. RESULTS: We included 122 patients, 78 (64%) treated with dual therapy and 44 (36%) treated with monotherapy. In the crude analysis, dual therapy was associated with a lower risk of delivery at <28 weeks' gestation (13%) compared with monotherapy (34%; crude risk ratio: 0.38 [95% confidence interval, CI: 0.19-0.75]). When adjusted for preoperative vaginal progesterone, results were attenuated (adjusted risk ratio: 0.45 [95% CI: 0.20-1.01]). In both the crude and adjusted analyses, the risk of sPTB was not statistically different at <24, <34 or <37 weeks' gestation. Dual therapy was associated with a greater pregnancy latency from cerclage to delivery (16.3 vs. 14.4 weeks; p = 0.04), and greater gestational age at delivery (37.3 vs. 35.8 weeks' gestation; p = 0.02) compared with monotherapy. CONCLUSION: While not statistically significant, the risk of sPTB was lower at all gestational ages studied in patients treated with dual therapy compared with monotherapy. Dual therapy was associated with longer pregnancy latency and greater gestational age at delivery compared with monotherapy. KEY POINTS: · Dual therapy did not decrease preterm birth risk compared with monotherapy.. · Dual therapy prolonged pregnancy compared with monotherapy.. · Dual therapy can be considered but further studies are needed..

Regional differences in utilization of 17α-hydroxyprogesterone caproate (17-OHP).

OBJECTIVES: To describe regional differences in utilization of 17α-hydroxyprogesterone caproate (17-OHP). METHODS: Retrospective cohort study of a large, US commercial managed care plan claims database with pharmacy coverage from 2008 to 2018. Singleton pregnancies with at least one prior spontaneous preterm birth (sPTB) were included. Regional and state-based differences in 17-OHP use were compared. Data were analyzed using t-tests and Fisher's exact tests. RESULTS: Of the 4,514 individuals with an indication for 17-OHP, 580 (12.8%) were prescribed 17-OHP. Regional and state-based differences in 17-OHP utilization were identified; Northeast 15.7%, Midwest 13.7%, South 12.0%, and West 10.4% (p=0.003). CONCLUSIONS: While significant regional differences in 17-OHP utilization were demonstrated, 17-OHP utilization remained low despite this cohort having insurance through a US commercial managed care plan. Suboptimal utilization demonstrates a disconnect between research and uptake in clinical practice. This underscores a need for implementation science in obstetrics to translate updated recommendations more effectively and efficiently into clinical practice.

Risk-Factor Based Lead Screening and Correlation with Blood Lead Levels in Pregnancy.

OBJECTIVES: Lead exposure has devastating neurologic consequences for children and may begin in utero. The American College of Obstetricians and Gynecologists recommends prenatal lead screening using a risk factor-based approach rather than universal blood testing. The clinical utility of this approach has not been studied. We evaluated a risk-factor based questionnaire to detect elevated blood lead levels in pregnancy. METHODS: We performed a secondary analysis of a cohort of parturients enrolled to evaluate the association of lead with hypertensive disorders of pregnancy. We included participants in this analysis if they had a singleton pregnancy ≥ 34 weeks' gestation with blood lead levels recorded. Participants completed a lead risk factor survey modified for pregnancy. We defined elevated blood lead as ≥ 2 µg/dL, as this was the clinically reportable level. RESULTS: Of 102 participants enrolled in the cohort, 92 had blood lead measured as part of the study. The vast majority (78%) had 1 or more risk factor for elevated lead using the questionnaire yet none had clinical blood lead testing during routine visits. Only two participants (2.2%) had elevated blood lead levels. The questionnaire had high sensitivity but poor specificity for predicting detectable lead levels (sensitivity 100%, specificity 22%). CONCLUSIONS FOR PRACTICE: Prenatal risk-factor based lead screening appears underutilized in practice and does not adequately discriminate between those with and without elevated blood levels. Given the complexity of the risk factor-based approach and underutilization, the benefit and cost-effectiveness of universal lead testing should be further explored.

Geographic variation in management of patients with placenta accreta spectrum: An international survey of experts (GPASS).

OBJECTIVE: To describe global geographic variations in the diagnosis and management of placenta accreta spectrum (PAS). METHODS: An international cross-sectional study was conducted among PAS experts practicing at medical institutions in member states of the United Nations. Survey questions focused on diagnostic evaluation and management strategies for PAS. RESULTS: A total of 134 centers participated. Participating centers represented each of the United Nations' designated regions. Of those, 118 (88%) reported practicing in a medium-volume or high-volume center. First-trimester PAS screen was reported in 35 (26.1%) centers. Respondents consistently implement guideline-supported care practices, including utilization of ultrasound as the primary diagnostic modality (134, 100%) and implementation of multidisciplinary care teams (115, 85.8%). Less than 10% of respondents reported routinely managing PAS without hysterectomy; these centers were predominantly located in Europe and Africa. Antepartum management and availability of mental health support for PAS patients varied widely. CONCLUSION: Worldwide, there is a strong adherence to PAS care guidelines; however, regional variations do exist. Comparing variations in care to outcomes will provide insight into the clinically significant practice variability.

Spontaneous version after preterm prelabor rupture of membranes.

BACKGROUND: Preterm prelabor rupture of membranes (PPROM), defined as rupture of membranes before the onset of labor at < 37 weeks' gestation, affects approximately 3% of all pregnancies. For PPROM prior to 34 weeks' gestation, in the absence of contraindications to expectant management, antibiotics are administered to increase the latency period and reduce the incidence of maternal and neonatal infection. The latency period additionally provides an opportunity for fetal presentation to change, which impacts the mode of delivery. It is important to better understand the incidence of spontaneous version after PPROM to enhance patient counseling with regard to the mode of delivery. OBJECTIVE: To determine the incidence of discordant fetal presentation, resulting from spontaneous version, between admission for PPROM and time of delivery for cephalic and non-cephalic fetuses among patients diagnosed with PPROM prior to 34 weeks' gestation and to compare characteristics of those with and without discordant fetal presentation. STUDY DESIGN: We performed a retrospective cohort study of singleton pregnancies diagnosed with PPROM identified using ICD-9/10-CM codes, < 34 weeks' gestation, admitted to a tertiary care center's antepartum service from 2011-2018. Patients were included if the fetal presentation was documented by ultrasound within 48 h of admission and PPROM, and delivery occurred >24 h after PPROM. Data are presented as proportions, median (interquartile range) or risk ratio and 95% confidence interval. RESULTS: We included 209 patients. Patient age, body mass index, parity, and race/ethnicity were similar among patients with cephalic and non-cephalic fetal presentations at admission. Patients with cephalic presentation at time of PPROM presented at a later gestational age than patients with a non-cephalic presentation. Among patients with a cephalic presentation at admission, the incidence of non-cephalic presentation at delivery was 11.7% (19/162), whereas with non-cephalic presentation at admission, the incidence of cephalic presentation at delivery was 21.3% (10/47). While there was an increased risk of spontaneous version resulting in a discordant presentation at delivery with non-cephalic presentation, this relationship was attenuated and not significant when adjusted for gestational age at time of PPROM.​ Patients with discordant presentation presented with PPROM at an earlier gestational age and had a longer latency period compared to patients with a concordant presentation. Patient age, body mass index, amniotic fluid assessment at admission, and infant birth weight were similar in those with and without a change in fetal presentation. CONCLUSION: Discordant fetal presentation resulting from spontaneous version from cephalic to non-cephalic presentation after PPROM occurred in 11.7% (19/162) of patients, while discordant presentation from non-cephalic to cephalic presentation occurred in 21.3% (10/47) of patients. Given the limited published data on spontaneous version after PPROM these results may impact patient counseling.

Effectiveness of 17-OHP for Prevention of Recurrent Preterm Birth: A Retrospective Cohort Study.

OBJECTIVE: 17-α-hydroxyprogesterone caproate (17-OHP) has been recommended by professional societies for the prevention of recurrent preterm birth, but subsequent clinical studies have reported conflicting efficacy results. This study aimed to contribute to the evidence base regarding the effectiveness of 17-OHP in clinical practice using real-world data. STUDY DESIGN: A total of 4,422 individuals meeting inclusion criteria representing recurrent spontaneous preterm birth (sPTB) were identified in a database of insurance claims, and 568 (12.8%) received 17-OHP. Crude and propensity score-matched recurrence rates and risk ratios (RRs) for the association of receiving 17-OHP on recurrent sPTB were calculated. RESULTS: Raw sPTB recurrence rates were higher among those treated versus not treated; after propensity score matching, no association was detected (26.3 vs. 23.8%, RR = 1.1, 95% CI: 0.9-1.4). CONCLUSION: We failed to identify a beneficial effect of 17-OHP for the prevention of spontaneous recurrent preterm birth in our observational, U.S. based cohort. KEY POINTS: · •We observed higher risk for sPTB in the group receiving 17-OHP in the unmatched analysis. · •After propensity-score matching, we still failed to identify a beneficial effect of 17-OHP on sPTB. · •Sensitivity analyses demonstrated robustness to the inclusion criteria and modeling assumptions..

Lead exposure and association with angiogenic factors and hypertensive disorders of pregnancy.

OBJECTIVES: Lead exposure has been associated with hypertensive disorders of pregnancy. Angiogenic factors, including soluble fms-like tyrosine kinase 1 (sFlt1) and placental growth factor (PlGF), are aberrant in preeclampsia, but have not been correlated with lead levels. We evaluated the association of lead exposure with angiogenic factors. STUDY DESIGN: This cross sectional study utilized a convenience sample of singleton pregnancies ≥34 weeks' gestation. Blood lead and angiogenic factors were measured before delivery; bone lead was measured postpartum. We dichotomized bone and blood lead into the top tertile versus the bottom tertiles and used log-binomial regression to assess the association between lead and a high angiogenic ratio. MAIN OUTCOME MEASURES: The outcomes were high sFlt1 to PlGF ratio and development of a hypertensive disorder of pregnancy. RESULTS: We enrolled 102 participants, of whom 98 had at least one lead measurement and an angiogenic factor result. Median bone lead was 3.8 ug/g (2.0 - 6.6) and median blood lead was 0.2 ug/dL (0.2 - 0.4). Incidence of hypertensive disorders of pregnancy was 31%. When comparing the highest tertile of bone lead to the bottom two tertiles, there was no association with a high sFlt1/PlGF ratio or hypertensive disorders of pregnancy. Similar results were observed for the exposure of blood lead. CONCLUSIONS: Lead exposure was not an important contributor to an elevated angiogenic factor ratio or hypertensive disorders of pregnancy in our U.S. POPULATION: However, lead exposure was modest in our population and we cannot exclude a relationship with hypertensive disorders of pregnancy.