Trial reportThe New England journal of medicine2015
A Randomized Trial of Progesterone in Women with Recurrent Miscarriages.
Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 16 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
77 citing papers in PubMed, 16 syntheses or guidelines pooled it, 299 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
- Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.The Cochrane database of systematic reviews · 2025Pooled it
- Research hotspots and trends in unexplained recurrent spontaneous abortion (URSA) from 2014 to 2024: a bibliometric analysis.Frontiers in medicine · 2025Pooled it
- Efficacy of therapeutic interventions for idiopathic recurrent pregnancy loss: a systematic review and network meta-analysis.Frontiers in medicine · 2025Pooled it
- Progestogens in women with threatened miscarriage or recurrent miscarriage: A meta-analysis.Acta obstetricia et gynecologica Scandinavica · 2024Pooled it
- Development and validation of prediction models for fetal growth restriction and birthweight: an individual participant data meta-analysis.Health technology assessment (Winchester, England) · 2024Pooled it
- A rapid improvement event: progesterone prescribing in prevention of miscarriage.BMJ open quality · 2024Pooled it
- The efficacy and safety of luteal phase support with progesterone following ovarian stimulation and intrauterine insemination: A systematic review and meta-analysis.Frontiers in endocrinology · 2022Pooled it
- Pregnancy-related complications and perinatal outcomes following progesterone supplementation before 20 weeks of pregnancy in spontaneously achieved singleton pregnancies: a systematic review and meta-analysis.Reproductive biology and endocrinology : RB&E · 2021Pooled it
- 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
- Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.The Cochrane database of systematic reviews · 2019Pooled it
- Prenatal administration of progestogens for preventing spontaneous preterm birth in women with a multiple pregnancy.The Cochrane database of systematic reviews · 2019Pooled it
- Care prior to and during subsequent pregnancies following stillbirth for improving outcomes.The Cochrane database of systematic reviews · 2018Pooled it
- Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.The Cochrane database of systematic reviews · 2018Pooled it
- Progestogen for treating threatened miscarriage.The Cochrane database of systematic reviews · 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
- Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.Health technology assessment (Winchester, England) · 2020Trial
- Progesterone Exposure in Pregnancy, Obstetric Stabilization, and Developmental Outcomes: A Focused Review of Direct and Indirect Pathways.Children (Basel, Switzerland) · 2026Review
- Progestogen supplementation to prevent miscarriage: Evidence and controversies.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Review
- Clinical, metabolomic, and proteomic profiles associated with reproductive outcomes in unexplained recurrent pregnancy loss.Frontiers in endocrinology · 2026Article
17 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
35 authors at 20 institutions in 5 countries.
Funding
Abstract
backgroundProgesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain.
methodsWe conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation.
resultsA total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, -4.0 to 9.0). There were no significant between-group differences in the rate of adverse events.
conclusionsProgesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181.).
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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.