Trial reportHealth technology assessment (Winchester, England)2020
Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.
Trial report in Health technology assessment (Winchester, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.
- Obstetric and neonatal outcomes after natural versus artificial cycle frozen embryo transfer and the role of luteal phase support: a systematic review and meta-analysis.Human reproduction update · 2023Pooled 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
- Article
- Progesterone in recurrent pregnancy loss: from controversial efficacy to mechanism-based patient stratification.Frontiers in pharmacology · 2026Review
- Article
- PERİDER-TJOD joint review on threatened abortion and guideline for its treatment.Turkish journal of obstetrics and gynecology · 2025Article
- Untargeted metabolomics reveals key pathways in miscarriage: steroid, folate, fatty acid & glycosaminoglycan metabolism.npj women's health · 2025Article
- Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial.Reproduction & fertility · 2025Article
- A risk prediction model of spontaneous miscarriage in women with threatened miscarriage: a prospective cohort study.Frontiers in medicine · 2025Article
- Exploring Progesterone Deficiency in First-Trimester Miscarriage and the Impact of Hormone Therapy on Foetal Development: A Scoping Review.Children (Basel, Switzerland) · 2024Article
- Molecular Determinants of Uterine Receptivity: Comparison of Successful Implantation, Recurrent Miscarriage, and Recurrent Implantation Failure.International journal of molecular sciences · 2023Review
- Article
- Body composition phase angle: A potential predictor of vitamin D status in early pregnancy.Food science & nutrition · 2023Article
- Identifying discrepancies between clinical practice and evidence-based guideline in recurrent pregnancy loss care, a tool for clinical guideline implementation.BMC pregnancy and childbirth · 2023Article
- Prevention of Pregnancy Loss: Combining Progestogen Treatment and Psychological Support.Journal of clinical medicine · 2023Review
- Approach to ovarian torsion with corpus luteum re-moval in early pregnancy.Qatar medical journal · 2023Article
- Progesterone: The Key Factor of the Beginning of Life.International journal of molecular sciences · 2022Review
- Chromosomally normal miscarriage is associated with vaginal dysbiosis and local inflammation.BMC medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
42 authors at 20 institutions in 3 countries.
Funding
Abstract
backgroundProgesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage.
objectives(1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding.
designA multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding.
settingA total of 48 hospitals in the UK.
participantsWomen aged 16-39 years with early pregnancy bleeding.
interventionsWomen aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400 mg of progesterone or a matched placebo from presentation to 16 weeks of gestation.
main outcome measuresThe primary outcome was live birth at ≥ 34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective.
resultsA total of 4153 women from 48 hospitals in the UK received either progesterone (
conclusionsProgesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets.
trial registrationCurrent Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326.
fundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
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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.