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

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dc.contributor.authorLim, A.
dc.contributor.authorSchuit, E.
dc.contributor.authorBloemenkamp, K.
dc.contributor.authorBernardus, R.
dc.contributor.authorDuvekot, J.
dc.contributor.authorErwich, J.
dc.contributor.authorvan Eyck, J.
dc.contributor.authorGroenwold, R.
dc.contributor.authorHasaart, T.
dc.contributor.authorHummel, P.
dc.contributor.authorKars, M.
dc.contributor.authorKwee, A.
dc.contributor.authorvan Oirschot, C.
dc.contributor.authorvan Pampus, M.
dc.contributor.authorPapatsonis, D.
dc.contributor.authorPorath, M.
dc.contributor.authorSpaanderman, M.
dc.contributor.authorWillekes, C.
dc.contributor.authorWilpshaar, J.
dc.contributor.authorMol, B.
dc.contributor.authoret al.
dc.date.issued2011
dc.description.abstractOBJECTIVE: To estimate whether administration of 17[alpha]-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 17[alpha]-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 17[alpha]-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 17[alpha]-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P=.32). Treatment with 17[alpha]-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17[alpha]-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: 17[alpha]-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.isrctn.org, ISRCTN40512715. LEVEL OF EVIDENCE: I
dc.description.statementofresponsibilityArianne 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. Mol, and Hein W. Bruinse
dc.identifier.citationObstetrics and Gynecology, 2011; 118(3):513-520
dc.identifier.doi10.1097/AOG.0b013e31822ad6aa
dc.identifier.issn0029-7844
dc.identifier.issn1873-233X
dc.identifier.orcidMol, B. [0000-0001-6887-0262] [0000-0001-8337-550X]
dc.identifier.urihttp://hdl.handle.net/2440/88474
dc.language.isoen
dc.publisherLippincott Williams & Wilkins
dc.rights© 2011 by The American College of Obstetricians and Gynecologists.
dc.source.urihttps://doi.org/10.1097/aog.0b013e31822ad6aa
dc.subjectCervix Uteri
dc.subjectHumans
dc.subjectPremature Birth
dc.subjectHydroxyprogesterones
dc.subjectProgesterone Congeners
dc.subjectPregnancy Outcome
dc.subjectInjections, Intramuscular
dc.subjectDouble-Blind Method
dc.subjectGestational Age
dc.subjectPregnancy
dc.subjectPregnancy, Multiple
dc.subjectPregnancy Trimester, Second
dc.subjectAdult
dc.subjectFemale
dc.subjectIntention to Treat Analysis
dc.subject17 alpha-Hydroxyprogesterone Caproate
dc.title17-alpha-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: A randomized controlled trial
dc.typeJournal article
pubs.publication-statusPublished

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