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

2021 ◽  
Author(s):  
Blair J. Wylie ◽  
Andrew L. Beam ◽  
Joe B. Hakim ◽  
Amy Zhou ◽  
Sonia Hernandez-Diaz ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Propensity Score ◽  
Evidence Base ◽  
Inclusion Criteria ◽  
Spontaneous Preterm Birth ◽  
Real World Data ◽  
Recurrence Rates ◽  
Key Points ◽  
Hydroxyprogesterone Caproate ◽  
Risk Ratios

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

Eligibility, Utilization, and Effectiveness of 17-Alpha Hydroxyprogesterone Caproate (17OHPC) in a Statewide Population-Based Cohort of Medicaid Enrollees

2021 ◽  
Author(s):  
Xi Wang ◽  
Stephanie M. Garcia ◽  
Katherine S. Kellom ◽  
Rupsa C. Boelig ◽  
Meredith Matone
Keyword(s):  
Preterm Birth ◽  
Neonatal Intensive Care ◽  
Population Based ◽  
Primary Objective ◽  
Birth Certificates ◽  
Spontaneous Preterm Birth ◽  
Initiation Rate ◽  
Live Births ◽  
Hydroxyprogesterone Caproate ◽  
Comparison Groups

Objectives The primary objective was to estimate the initiation and adherence rates of 17 α-hydroxyprogesterone caproate (17OHPC) among eligible mothers in a statewide population-based cohort of Medicaid enrollees. The secondary objectives were to (1) determine the association of maternal sociodemographic and clinical characteristics with 17OHPC utilization and (2) assess the real-world effectiveness of 17OHPC on recurrent preterm birth prevention and admission to neonatal intensive care unit (NICU). Study Design This is a retrospective cohort study using a linked, longitudinal administrative dataset of birth certificates and medical assistance claims. Medicaid-enrolled mothers in Pennsylvania were included in this study if they had at least one singleton live birth from 2014 to 2016 following at least one spontaneous preterm birth. Maternal Medicaid claims were used to ascertain the use of 17OHPC from various manufacturers, including compounded formulations. Propensity score matching was used to create a covariate balance between 17OHPC treatment and comparison groups. Results We identified 4,781 Medicaid-covered 17OHPC-eligible pregnancies from 2014 to 2016 in Pennsylvania, 3.4% of all Medicaid-covered singleton live births. The population-based initiation rate was 28.5% among eligible pregnancies. Among initiators, 50% received ≥16 doses as recommended, while 10% received a single dose only. The severity of previous spontaneous preterm birth was the strongest predictor for the initiation and adherence of 17OHPC. In the matched treatment (n = 1,210) and comparison groups (n = 1,210), we found no evidence of 17OHPC effectiveness. The risks of recurrent preterm birth (relative risk [RR] 1.10, 95% confidence interval [CI] 0.97–1.24) and births admitted to NICU (RR 1.00, 95% CI 0.84–1.18) were similar in treated and comparison mothers. Conclusion The 17OHPC-eligible population represented 3.4% of singleton live births. Less than one-third of eligible mothers initiated treatment. Among initiators, 50% were treatment adherent. We found no difference in the risk of recurrent preterm birth or admission to NICU between treatment and comparison groups. Key Points

Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

2021 ◽  
pp. 38-42
Author(s):  
Emily A. Oliver ◽  
Amanda Roman-Camargo
Keyword(s):  
Preterm Birth ◽  
Child Health ◽  
Human Development ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
Supplemental Oxygen ◽  
Spontaneous Preterm Birth ◽  
Increased Risk ◽  
Hydroxyprogesterone Caproate ◽  
History Of

Women with a history of spontaneous preterm birth have an increased risk of recurrent preterm birth. In this randomized placebo-controlled trial funded by the National Institute of Child Health and Human Development, patients between 16 and 20 weeks of gestation with a history of spontaneous preterm birth were administered intramuscular 17 alpha-hydroxyprogesterone caproate (17P) or placebo, weekly until 36 weeks of gestation. Treatment with 17P significantly reduced the rate of preterm birth (36.3% vs. 54.9%, p <0.001). Rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen were all significantly decreased in the 17P group. In women with a history of spontaneous preterm birth, weekly 17P decreases the rate of recurrent preterm birth.

scholarly journals Impact of Obesity on the Rate of Recurrent Spontaneous Preterm Birth in Women Treated with 17-alpha Hydroxyprogesterone Caproate

2018 ◽  
Vol 35 (09) ◽  
pp. 809-814 ◽  
Author(s):  
Lara Lemon ◽  
Allison Serra ◽  
Shringi Sharma ◽  
Raman Venkataramanan ◽  
Steve Caritis ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Pharmacokinetic Studies ◽  
Maternal Body Mass Index ◽  
Omega 3 ◽  
Spontaneous Preterm Birth ◽  
Obesity Class ◽  
Hydroxyprogesterone Caproate ◽  
The Impact

Objective We sought to determine if the rate of recurrent spontaneous preterm birth (PTB) in women treated with 17-α hydroxyprogesterone caproate (17-OHPC) is modified by maternal body mass index (BMI). Study Design We performed a secondary analysis of the Maternal-Fetal Medicine Units Network omega-3 fatty acid supplementation to prevent recurrent PTB randomized controlled trial. All women received 17-OHPC. Results A total of 708 women were included. Rates of spontaneous PTB did not vary significantly by BMI category. With stratification by obesity class and gestational age at delivery, the unadjusted risk for PTB using earlier gestational cutoffs (< 35, 32, and 28 weeks) demonstrated an association between preterm delivery and increasing severity of obesity. With adjustment for potential confounders, there was no statistically significant relationship between BMI and spontaneous PTB. Conclusion We demonstrated that the risk of PTB in women receiving 250 mg 17-OHPC is not dependent on maternal BMI after adjustment for confounding variables. Pharmacokinetic studies have demonstrated a wide variation in plasma concentration of 17-OHPC across the population with likely considerable overlap in plasma concentrations among the obese and nonobese population. Further studies are needed to evaluate the impact of BMI on efficacy of 17-OHPC prior to any dose adjustment in this population.

scholarly journals Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth

2020 ◽  
Author(s):  
Baha Sibai ◽  
George R. Saade ◽  
Anita F. Das ◽  
Jennifer Gudeman
Keyword(s):  
Preterm Birth ◽  
Gestational Diabetes ◽  
Neonatal Death ◽  
Safety Data ◽  
Spontaneous Preterm Birth ◽  
Relative Risks ◽  
Hydroxyprogesterone Caproate ◽  
History Of ◽  
Favorable Safety ◽  
Confirmatory Trial

Abstract 17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called “PROLONG”, which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25–1.78) for miscarriage, 1.83 (0.68–4.91) for stillbirth, and 0.86 (0.53–1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo.

scholarly journals The Effect of Prior Term Birth on Risk of Recurrent Spontaneous Preterm Birth

2017 ◽  
Vol 35 (04) ◽  
pp. 380-384 ◽  
Author(s):  
Amy Turitz ◽  
Michal Elovitz ◽  
Lisa Levine ◽  
Stephanie Purisch
Keyword(s):  
Preterm Birth ◽  
Retrospective Cohort ◽  
Statistical Difference ◽  
Primary Outcome ◽  
Second Trimester ◽  
Prevention Strategies ◽  
Spontaneous Preterm Birth ◽  
Term Birth ◽  
Hydroxyprogesterone Caproate ◽  
Term Births

Objective The objective of this study was to evaluate the effect of prior term birth on recurrent spontaneous preterm birth (sPTB) risk. Study Design Retrospective cohort study of 211 women with prior sPTB, comparing women with and without prior term births. The primary outcome was recurrent sPTB <37 weeks. Analyses stratified by gestational age of prior sPTB and adjusted for confounders using multivariable logistic regression. Results The overall sPTB rate was 33.7%, with no statistical difference between women with and without prior term births (28.9 vs. 37.7%, p = 0.2). Among women with prior second-trimester loss (16–236/7 weeks), those with a term birth had a decreased sPTB rate (15.4 vs. 43.2%, p = 0.02), which persisted after adjusting for age and 17-α hydroxyprogesterone caproate use. For women with prior sPTB ≥24 weeks, there was no difference in sPTB with and without prior term births (29.5 vs. 26.6%, p = 0.7). A term birth as the most recent delivery lowered, but did not eliminate, the sPTB risk (19.1 vs. 36.4%, p = 0.1). Conclusion Prior term birth lowers the risk of recurrent sPTB for women with prior second-trimester loss, but not for women with prior sPTB ≥24 weeks. Women with prior preterm and term births should be counseled accordingly and all sPTB prevention strategies should be recommended.

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