Trial reportThe New England journal of medicine2003
Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.
Trial report in The New England journal of medicine, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 7 registered trials, which are not on this map. Cited by 396 papers, 16 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Multifetal Gestation (STTARS)
Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate
A Randomized Trial of Omega-3 Fatty Acid Supplementation to Prevent Preterm Birth in Pregnancies at High Risk
17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial
A Study of the Pharmacology of 17-Hydroxyprogesterone Caproate in Pregnancy
Preventing Preterm Birth With a Pessary
A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
Who cites it
396 citing papers in PubMed, 16 syntheses or guidelines pooled it, 1,558 citations in OpenAlex.
- Progestogen therapy in threatened miscarriage and unexplained recurrent pregnancy loss: Recommendations by the Thai interest group.The journal of obstetrics and gynaecology research · 2025Guideline
- The long-term effect of prenatal progesterone treatment on child development, behaviour and health: a systematic review.BJOG : an international journal of obstetrics and gynaecology · 2021Pooled it
- 17-Alpha-Hydroxyprogesterone vs. Placebo for Preventing of Recurrent Preterm Birth: A Systematic Review and Meta-Analysis of Randomized Trials.Frontiers in medicine · 2021Pooled it
- Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies.The Cochrane database of systematic reviews · 2020Pooled it
- Adjuvant 17-hydroxyprogesterone caproate in women withultrasound-indicated cerclage: a systematic review and meta-analysis.The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians · 2020Pooled it
- Cervical pessary to prevent preterm birth in asymptomatic high-risk women: a systematic review and meta-analysis.American journal of obstetrics and gynecology · 2020Pooled 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
- Oral progesterone for the prevention of recurrent preterm birth: systematic review and metaanalysis.American journal of obstetrics & gynecology MFM · 2019Pooled it
- 17α-Hydroxyprogesterone Caproate and the Risk of Glucose Intolerance in Pregnancy: A Systematic Review and Meta-analysis.Obstetrics and gynecology · 2019Pooled it
- Adjuvant 17-hydroxyprogesterone caproate in women with history-indicated cerclage: A systematic review and meta-analysis.Acta obstetricia et gynecologica Scandinavica · 2019Pooled it
- Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.The Cochrane database of systematic reviews · 2017Pooled it
- Pooled it
- Cervical stitch (cerclage) for preventing preterm birth in singleton pregnancy.The Cochrane database of systematic reviews · 2017Pooled it
- The Influence of Oral Dydrogesterone and Vaginal Progesterone on Threatened Abortion: A Systematic Review and Meta-Analysis.BioMed research international · 2017Pooled it
- 17-Hydroxyprogesterone caproate in triplet pregnancy: an individual patient data meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2016Pooled it
- A randomised feasibility tolerability study of aminophylline for the prevention of preterm labour.BMC pregnancy and childbirth · 2025Trial
- Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial.JAMA network open · 2024Trial
- Relationship between plasma concentration of 17-hydroxyprogesterone caproate and gestational age at preterm delivery.American journal of obstetrics & gynecology MFM · 2023Trial
- Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study): A multicentre, randomised, double-blinded, placebo-controlled trial.PLoS medicine · 2022Trial
336 more citing papers are in PubMed but not listed here.
Corrections and comments
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- Erratum issued
- Erratum issued
Authors and funding
23 authors at 18 institutions in 3 countries.
Funding
Abstract
backgroundWomen who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery.
methodsWe conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle.
resultsBase-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen.
conclusionsWeekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.
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What OpenQuestion holds
Registered trials
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.