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

Trends in Spontaneous and Medically Indicated Preterm Birth in Twins versus Singletons: A California Cohort 2007 to 2011

2021 ◽  
Author(s):  
Amen Ness ◽  
Jonathan A. Mayo ◽  
Yasser Y. El-Sayed ◽  
Maurice L. Druzin ◽  
David K. Stevenson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Preterm Birth ◽  
Population Based ◽  
Birth Certificates ◽  
Premature Rupture Of Membranes ◽  
Premature Rupture ◽  
Live Births ◽  
Preterm Premature Rupture ◽  
Key Points ◽  
Hospital Discharge Records

Objective The study aimed to describe preterm birth (PTB) rates, subtypes, and risk factors in twins compared with singletons to better understand reasons for the decline in PTB rate between 2007 and 2011. Study Design This was a retrospective population-based analysis using the California linked birth certificates and maternal-infant hospital discharge records from 2007 to 2011. The main outcomes were overall, spontaneous (following spontaneous labor or preterm premature rupture of membranes), and medically indicated PTB at various gestational age categories: <37, <32, and 34 to 36 weeks in twins and singletons. Results Among the 2,290,973 singletons and 28,937 twin live births pairs included, overall PTB <37 weeks decreased by 8.46% (6.77–6.20%) in singletons and 7.17% (55.31–51.35%) in twins during the study period. In singletons, this was primarily due to a 24.91% decrease in medically indicated PTB with almost no change in spontaneous PTB, whereas in twins indicated PTB declined 7.02% and spontaneous PTB by 7.39%. Conclusion Recent declines in PTB in singletons appear to be largely due to declines in indicated PTB, whereas both spontaneous and indicated PTB declined in twins. Key Points

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

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 Burden of early-term birth on adverse infant outcomes: a population-based cohort study in Brazil

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017789 ◽  
Author(s):  
Maria do Carmo Leal ◽  
Ana Paula Esteves-Pereira ◽  
Marcos Nakamura-Pereira ◽  
Rosa Maria Soares Madeira Domingues ◽  
Marcos Augusto Bastos Dias ◽  
...  
Keyword(s):  
Cohort Study ◽  
Neonatal Death ◽  
Neonatal Intensive Care ◽  
Oxygen Therapy ◽  
Population Based ◽  
Medical Conditions ◽  
Infant Outcomes ◽  
Early Term ◽  
Live Births ◽  
National Rate

ObjectivesTo estimate the national rate of early-term live births in Brazil and to evaluate the effect of birth at 37 and 38 weeks’ gestation, as compared with 39 and 40 weeks’ gestation on infant outcomes according to precursors of birth and the existence of maternal/fetal medical conditions.DesignNational perinatal population-based cohort study.Setting266 maternity services located in the five Brazilian macroregions.Participants18 652 singleton live newborns from 37 0/7 to 40 6/7 weeks of gestation.Main outcome measuresResuscitation in delivery room, oxygen therapy, transient tachypnoea, admission to neonatal intensive care unit (NICU), hypoglycaemia, use of antibiotics, phototherapy, phototherapy after hospital discharge, neonatal death and breastfeeding.ResultsEarly terms accounted for 35% (95% CI 33.4% to 36.7%) of all live births. Among provider-initiated births in women without medical conditions, infants of 37 and 38 weeks’ gestation had higher odds of oxygen therapy (adjusted OR (AOR) 2.93, 95% CI 1.72 to 4.98 and AOR 1.92 95% CI 1.18 to 3.13), along with admission to NICU (AOR 2.01, 95% CI 1.18 to 3.41 and AOR 1.56, 95% CI 1.02 to 2.60), neonatal death (AOR 14.40, 95% CI 1.94 to 106.69 and AOR 13.76,95% CI 2.84 to 66.75), hypoglycaemia in the first 48 hours of life (AOR 7.86, 95% CI 1.95 to 31.71 and AOR 5.76, 95% CI 1.63 to 20.32), transient tachypnoea (AOR 2.98, 95% CI 1.57 to 5.65 and AOR 2.12, 95% CI 1.00 to 4.48) and the need for phototherapy within the first 72 hours of life (AOR 3.59, 95% CI 1.95 to 6.60 and AOR 2.29, 95% CI 1.49 to 3.53), yet lower odds of breastfeeding up to 1 hour after birth (AOR 0.67, 95% CI 0.53 to 0.86 and AOR 0.87, 95% CI 0.76 to 0.99) and exclusive breastfeeding during hospital stay (AOR 0.68, 95% CI 0.51 to 0.89 and AOR 0.84, 95% CI 0.71 to 0.99).ConclusionBirth at 37 and 38 weeks’ gestation increased the risk of most adverse infant outcomes analysed, especially among provider-initiated births and should be avoided before 39 weeks’ gestation in healthy pregnancies.

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