568: Risk factors for spontaneous preterm birth in African-American and Caucasian women receiving 17α-hydroxyprogesterone caproate

2012 ◽  
Vol 206 (1) ◽  
pp. S258-S259 ◽  
Author(s):  
Julia Timofeev ◽  
Jasbir Singh ◽  
Niki Istwan ◽  
Debbie Rhea ◽  
Rita Driggers
2013 ◽  
Vol 31 (01) ◽  
pp. 055-060 ◽  
Author(s):  
Jasbir Singh ◽  
Niki Istwan ◽  
Debbie Rhea ◽  
Rita Driggers ◽  
Julia Timofeev

2021 ◽  
Vol 81 (01) ◽  
pp. 61-69
Author(s):  
Ruben-J. Kuon ◽  
Richard Berger ◽  
Werner Rath

Abstract Background Prior spontaneous preterm birth is a strong risk factor for the recurrence of spontaneous preterm birth in a subsequent pregnancy and has been evaluated in prevention studies using progesterone (natural progesterone administered orally or vaginally, and 17-hydroxyprogesterone caproate [17-OHPC]) as a selection criterion. Based on the findings of a randomized, placebo-controlled study, 17-OHPC was approved for use in 2011 by the Food and Drug Administration in the USA for the prevention of recurrent preterm birth. The approval was granted with qualification that a subsequent confirmatory study would need to be carried out, the results of which have just been published (PROLONG trial). Method A systematic literature search for the period from 1970 to April 2020 using the search terms “preterm birth” and “17-OHPC” or “progesterone” was carried out. Only randomized, placebo-controlled studies of women with singleton pregnancies who received 17-OHPC to prevent recurrent preterm birth were included in the subsequent meta-analysis. The relative risk and associated 95% confidence intervals were calculated. The heterogeneity between studies was evaluated with I2 statistics. Results In addition to the original study used for the approval and the PROLONG trial, only one other study was found which met the inclusion criteria (total number of patients: 2221). With considerable heterogeneity between the studies, particularly with respect to the risk factors for preterm birth, the comparison between 17-OHPC and placebo showed no significant reduction in preterm birth rates before 37, 35 and 32 weeks of gestation and no significant differences with regard to the prevalence of miscarriage before 20 weeks of gestation or fetal deaths (antepartum or intrapartum) after 20 weeks of gestation and neonatal morbidity. Conclusion Based on the currently available data, 17-OHPC cannot be recommended for the prevention of recurrent preterm birth. Further randomized, placebo-controlled studies with clearly defined, comparable risk factors are required to identify the group of pregnant women which could benefit from the use of 17-OHPC to prevent preterm birth.


2021 ◽  
Vol 49 (8) ◽  
pp. 030006052110346
Author(s):  
Techane Sisay Tuji ◽  
Addisu Dabi Wake ◽  
Gezahegn Badeg Adere ◽  
Aselefu Beka Wedajo ◽  
Batu Dekeba Obole ◽  
...  

Objective To assess the prevalence of spontaneous preterm births and to identify the associated risk factors. Methods This single-centre cross-sectional study enrolled women that experienced a preterm birth as registered on the neonatal log-book between 30 December 2019 and 30 December 2020. A pre-tested structured checklist was used to collect data (sociodemographic characteristics; obstetric-related factors; medical history; and pregnancy-related factors). Bivariate logistic regression analyses were applied to identify factors associated with spontaneous preterm birth. A multivariate model identified significant independent risk factors. Results A total of 310 patients participated in the study. The prevalence of spontaneous preterm birth in this population was 67.1% (208 of 310; 95% confidence interval [CI] 61.5, 71.9). Patients without a partner (adjusted odds ratio [AOR] = 1.470, 95% CI 1.23, 4.42), patients residing in a rural area (AOR = 2.51, 95% CI 1.123, 5.513) and those with a history of PIH during their current pregnancy (AOR = 0.104, 95% CI 0.053, 0.014) were significantly more likely to have a spontaneous preterm birth. Conclusion The prevalence of spontaneous preterm birth in in this study was high. Healthcare providers and all stakeholders should focus on screening pregnant women at the risk of spontaneous preterm birth.


2013 ◽  
Vol 21 (2) ◽  
pp. 244-250 ◽  
Author(s):  
Chandrasekhar Thota ◽  
Ramkumar Menon ◽  
Stephen J. Fortunato ◽  
Lina Brou ◽  
Jae-Eun Lee ◽  
...  

Author(s):  
Xi Wang ◽  
Stephanie M. Garcia ◽  
Katherine S. Kellom ◽  
Rupsa C. Boelig ◽  
Meredith Matone

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


Author(s):  
Blair J. Wylie ◽  
Andrew L. Beam ◽  
Joe B. Hakim ◽  
Amy Zhou ◽  
Sonia Hernandez-Diaz ◽  
...  

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


Author(s):  
Emily A. Oliver ◽  
Amanda Roman-Camargo

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.


2018 ◽  
Vol 35 (09) ◽  
pp. 809-814 ◽  
Author(s):  
Lara Lemon ◽  
Allison Serra ◽  
Shringi Sharma ◽  
Raman Venkataramanan ◽  
Steve Caritis ◽  
...  

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.


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