A Trial of 17 Alpha-Hydroxyprogesterone Caproate to Prevent Prematurity in Twins
- 2 August 2007
- journal article
- research article
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 357 (5), 454-461
- https://doi.org/10.1056/nejmoa070641
Abstract
In singleton gestations, 17 alpha-hydroxyprogesterone caproate (17P) has been shown to reduce the rate of recurrent preterm birth. This study was undertaken to evaluate whether 17P would reduce the rate of preterm birth in twin gestations. We performed a randomized, double-blind, placebo-controlled trial in 14 centers. Healthy women with twin gestations were assigned to weekly intramuscular injections of 250 mg of 17P or matching placebo, starting at 16 to 20 weeks of gestation and ending at 35 weeks. The primary study outcome was delivery or fetal death before 35 weeks of gestation. Six hundred sixty-one women were randomly assigned to treatment. Baseline demographic data were similar in the two study groups. Six women were lost to follow-up; data from 655 were analyzed (325 in the 17P group and 330 in the placebo group). Delivery or fetal death before 35 weeks occurred in 41.5% of pregnancies in the 17P group and 37.3% of those in the placebo group (relative risk, 1.1; 95% confidence interval [CI], 0.9 to 1.3). The rate of the prespecified composite outcome of serious adverse fetal or neonatal events was 20.2% in the 17P group and 18.0% in the placebo group (relative risk, 1.1; 95% CI, 0.9 to 1.5). Side effects of the injections were frequent in both groups, occurring in 65.9% and 64.4% of subjects, respectively (P=0.69), but were generally mild and limited to the injection site. Treatment with 17 alpha-hydroxyprogesterone caproate did not reduce the rate of preterm birth in women with twin gestations. (ClinicalTrials.gov number, NCT00099164.)This publication has 11 references indexed in Scilit:
- Progesterone and the Risk of Preterm Birth among Women with a Short CervixNew England Journal of Medicine, 2007
- 17α-hydroxyprogesterone caproate for the prevention of preterm birth among women at increased risk: A systematic review and meta-analysis of randomized controlled trialsAmerican Journal of Obstetrics and Gynecology, 2006
- Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United StatesObstetrics & Gynecology, 2005
- Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone CaproateNew England Journal of Medicine, 2003
- Metronidazole to Prevent Preterm Delivery in Pregnant Women with Asymptomatic Bacterial VaginosisNew England Journal of Medicine, 2000
- Low-Dose Aspirin to Prevent Preeclampsia in Women at High RiskNew England Journal of Medicine, 1998
- The preterm prediction study: Risk factors in twin gestationsAmerican Journal of Obstetrics and Gynecology, 1996
- Survival analysis in natural history studies of diseaseStatistics in Medicine, 1989
- Properties of the urn randomization in clinical trialsControlled Clinical Trials, 1988
- Discrete Sequential Boundaries for Clinical TrialsBiometrika, 1983