Trial reportObstetrics and gynecology2011
17α-hydroxyprogesterone caproate for the prevention of adverse neonatal outcome in multiple pregnancies: a randomized controlled trial.
Trial report in Obstetrics and gynecology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 10 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 10 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- Timing of Delivery for Twins With Growth Discordance and Growth Restriction: An Individual Participant Data Meta-analysis.Obstetrics and gynecology · 2022Pooled it
- The use of progesterone during pregnancy to prevent preterm birth.Saudi medical journal · 2020Pooled it
- Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.The Cochrane database of systematic reviews · 2019Pooled it
- Correlation between neonatal outcomes of twins depends on the outcome: secondary analysis of twelve randomised controlled trials.BJOG : an international journal of obstetrics and gynaecology · 2018Pooled it
- Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.The Cochrane database of systematic reviews · 2017Pooled it
- Prospective risk of stillbirth and neonatal complications in twin pregnancies: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2016Pooled it
- 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016Pooled it
- Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2015Pooled it
- Prenatal administration of progesterone for preventing preterm birth in women considered to be at risk of preterm birth.The Cochrane database of systematic reviews · 2013Pooled it
- Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials.BMC pregnancy and childbirth · 2012Pooled it
- Prenatal 17-Alpha-Hydroxyprogesterone Caproate Exposure in Twins and Childhood Outcomes: 14-Year Follow-Up of a Randomised Trial.BJOG : an international journal of obstetrics and gynaecology · 2026Trial
- Article
- Progesterone, cerclage, pessary, or acetylsalicylic acid for prevention of preterm birth in singleton and multifetal pregnancies - A systematic review and meta-analyses.Frontiers in medicine · 2023Review
- Article
- Intramuscular progesterone in women with twins and a prior singleton spontaneous preterm birth.American journal of obstetrics & gynecology MFM · 2020Article
- SMFM Special Statement: State of the science on multifetal gestations: unique considerations and importance.American journal of obstetrics and gynecology · 2019Review
- Development and evaluating multimarker models for guiding treatment decisions.BMC medical informatics and decision making · 2018Article
- What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth.Seminars in perinatology · 2016Review
- Prevention of preterm delivery with 17-hydroxyprogesterone caproate: pharmacologic considerations.Seminars in perinatology · 2014Review
- Mechanical signaling in reproductive tissues: mechanisms and importance.Reproductive sciences (Thousand Oaks, Calif.) · 2014Review
Corrections and comments
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Authors and funding
21 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo estimate whether administration of 17α-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate.
methodsWe 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.
resultsWe 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).
conclusion17α-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies. CLINICAL
trial registrationISRCTN Register, www.isrctn.org, ISRCTN40512715.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.