17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: A randomized controlled trial

Arianne C. Lim*, Ewoud Schuit, Kitty Bloemenkamp, Rob E. Bernardus, Johannes J. Duvekot, Jan Jaap H.M. Erwich, Jim Van Eyck, Rolf H.H. Groenwold, Tom H.M. Hasaart, Piet Hummel, Michael M. Kars, Anneke Kwee, Charlotte M. Van Oirschot, Mariëlle G. Van Pampus, Dimitri Papatsonis, Martina M. Porath, Marc E. Spaanderman, Christine Willekes, Janine Wilpshaar, Ben W.J. MolHein W. Bruinse

*Corresponding author for this work

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Abstract

Objective: To estimate whether administration of 17α- hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate. Methods: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17α-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation. Results: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17α-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17α-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P=.32). Treatment with 17α-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17α- hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28). Conclusion: 17α-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies.

Original languageEnglish
Pages (from-to)513-520
Number of pages8
JournalObstetrics and Gynecology
Volume118
Issue number3
DOIs
Publication statusPublished - Sep 2011

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    Lim, A. C., Schuit, E., Bloemenkamp, K., Bernardus, R. E., Duvekot, J. J., Erwich, J. J. H. M., Van Eyck, J., Groenwold, R. H. H., Hasaart, T. H. M., Hummel, P., Kars, M. M., Kwee, A., Van Oirschot, C. M., Van Pampus, M. G., Papatsonis, D., Porath, M. M., Spaanderman, M. E., Willekes, C., Wilpshaar, J., ... Bruinse, H. W. (2011). 17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: A randomized controlled trial. Obstetrics and Gynecology, 118(3), 513-520. https://doi.org/10.1097/AOG.0b013e31822ad6aa