Trial reportBJOG : an international journal of obstetrics and gynaecology2015
Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial.
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03202836 (Vaginal Progesterone Supplementation in the Management of Preterm Labor), which is not on this map. Cited by 14 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.
Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- Effectiveness of oral dydrogesterone compared to placebo in reducing the risk of preterm birth: a systematic review and meta-analysis.BMC pregnancy and childbirth · 2026Pooled it
- Progestogens for maintenance tocolysis in symptomatic women. A systematic review and meta-analysis.PloS one · 2023Pooled it
- Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized Controlled Trial.Maternal and child health journal · 2021Trial
- Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial.BMC pregnancy and childbirth · 2021Trial
- Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis.BMC pregnancy and childbirth · 2017Trial
- Effectiveness of a cervical pessary for women who did not deliver 48 h after threatened preterm labor (Assessment of perinatal outcome after specific treatment in early labor: Apostel VI trial).BMC pregnancy and childbirth · 2016Trial
- Preventing Preterm Birth: The Search for Tocolytic Synergism.Reproductive sciences (Thousand Oaks, Calif.) · 2025Review
- Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/025, September 2022) - Part 2 with Recommendations on the Tertiary Prevention of Preterm Birth and on the Management of Preterm Premature Rupture of Membranes.Geburtshilfe und Frauenheilkunde · 2023Article
- The role of vaginal progesterone in established pre-term labor: A randomized controlled trial.Journal of family medicine and primary care · 2022Article
- The role of neutrophil activation in determining the outcome of pregnancy and modulation by hormones and/or cytokines.Clinical and experimental immunology · 2019Review
- Prevention and Therapy of Preterm Birth. Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/025, February 2019) - Part 2 with Recommendations on the Tertiary Prevention of Preterm Birth and the Management of Preterm Premature Rupture of Membranes.Geburtshilfe und Frauenheilkunde · 2019Article
- Progesterone - Effective for Tocolysis and Maintenance Treatment After Arrested Preterm Labour?: Critical Analysis of the Evidence.Geburtshilfe und Frauenheilkunde · 2019Article
- Use of progesterone supplement therapy for prevention of preterm birth: review of literatures.Obstetrics & gynecology science · 2017Review
- Preterm Birth Prevention: Effects of Vaginal Progesterone Administration on Blood Flow Impedance in Uterine-Fetal Circulation by Doppler Sonography.Global journal of health science · 2015Article
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Authors and funding
35 authors at 15 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour.
designMulticentre, randomised, double-blind, placebo-controlled trial.
settingTwenty-nine centres in Switzerland and Argentina. POPULATION: A total of 385 women with preterm labour (24(0/7) to 33(6/7) weeks of gestation) treated with acute tocolysis.
methodsParticipants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis.
main outcome measuresPrimary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis.
resultsPreterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group.
conclusionThere is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour.
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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.