Background Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or “17P”) to placebo has been published, and this trial was stopped early due to a large treatment benefit. Objective This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation. Study Design This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (clinicaltrials.gov: NCT 01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 160/7 to 206/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250 mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB < 35 weeks and a neonatal morbidity composite index. The composite included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB < 35 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%–11%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal/early infant death assuming a 4% fetal/early infant death rate. Analysis was performed according to the intention-to-treat principle. Results Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71–1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68–1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4–1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (n = 391; 23% of all patients), although the rate of PTB < 35 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk = 0.88 [95% CI: 0.55, 1.40]. Conclusion In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death.

No abstract

I.

BackgroundMobile health (mHealth) is growing rapidly, but more studies are needed on how to optimize programs, including optimal timing of messaging, dose of exposure, and value of interactive features. This study evaluates final outcomes of text4baby (a text message service for pregnant and postpartum women) from a randomized trial performed in a population of pregnant female soldiers and family members.ObjectiveThe study aims were to evaluate (1) treatment effects and (2) dose-response effects of text4baby on behavioral outcomes compared to control (no text4baby) condition.MethodsThe study was a randomized trial of text4baby at Madigan Army Medical Center. Female military health beneficiaries who met inclusion criteria were eligible for the study. Participants provided consent, completed a baseline questionnaire, and then were randomized to enroll in text4baby or not. They were followed up at 3 time points thereafter through delivery of their baby. Generalized estimating equation models were used to evaluate outcomes. We examined treatment effects and the effects of higher doses of text4baby messages on outcomes.ResultsWe report descriptive statistics including dosage of text messages delivered. The main finding was a significant effect of high exposure to text4baby on self-reported alcohol consumption postpartum (OR 0.212, 95% CI 0.046-0.973, P=.046), as measured by the question “Since you found out about your pregnancy, have you consumed alcoholic beverages?” The text4baby participants also reported lower quantities of alcohol consumed postpartum.ConclusionsStudies of text4baby have helped to build the mHealth evidence base. The effects of text4baby offer lessons for future scalable mHealth programs and suggest the need to study dose-response effects of these interventions.