Trial reportBJOG : an international journal of obstetrics and gynaecology2013
Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double-blind multicentre trial.
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02329535 (Comparing a Double Dose of Vaginal Progesterone to no Treatment for the Prevention of Preterm Birth in Twins Pregnancy and Short Cervix), which is not on this map. Cited by 33 papers, 12 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.
Comparing a Double Dose of Vaginal Progesterone to no Treatment for the Prevention of Preterm Birth in Twins Pregnancy and Short Cervix
Who cites it
33 citing papers in PubMed, 12 syntheses or guidelines pooled it, 118 citations in OpenAlex.
- Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in twin gestations: a systematic review and meta-analysis.American journal of obstetrics and gynecology · 2023Pooled it
- Prevention of Preterm Birth by Cervical Pessary Combined with Vaginal Progesterone: a Systematic Review and Meta-analysis with Trial Sequential Analysis.Reproductive sciences (Thousand Oaks, Calif.) · 2023Pooled it
- Timing of Delivery for Twins With Growth Discordance and Growth Restriction: An Individual Participant Data Meta-analysis.Obstetrics and gynecology · 2022Pooled it
- Vaginal progesterone for the prevention of preterm birth and adverse perinatal outcomes in twin gestations with a short cervix: an updated individual patient data meta-analysis.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2022Pooled 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
- Vaginal progesterone decreases preterm birth and neonatal morbidity and mortality in women with a twin gestation and a short cervix: an updated meta-analysis of individual patient data.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 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
- Prenatal exposure to vaginal progesterone for the prevention of preterm birth is not associated with abnormal psychopathological and cognitive profiles in dichorionic twins at 6 to 9 years of age: a follow-up study of a randomized controlled trial.American journal of obstetrics and gynecology · 2025Trial
- Development of children born to women with twin pregnancies treated with cervical pessary or vaginal progesterone: Follow-up of a randomized controlled trial.Acta obstetricia et gynecologica Scandinavica · 2023Trial
- The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial.BMC pregnancy and childbirth · 2020Trial
- Spectrum of Cervical Insufficiency: Management Strategies from Asymptomatic Shortening to Emergent Membrane Prolapse.Journal of clinical medicine · 2025Review
- Prognostic value of cervical length for spontaneous preterm birth in asymptomatic women with twin pregnancy: meta-analysis of individual participant data.BMJ medicine · 2025Article
- 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
- 17-alpha hydroxyprogesterone caproate for the prevention of recurrent preterm birth among singleton pregnant women with a prior history of preterm birth: a systematic review and meta-analysis of six randomized controlled trials.Obstetrics & gynecology science · 2021Article
- Progesterone for the Prevention of Preterm Birth - an Update of Evidence-Based Indications.Geburtshilfe und Frauenheilkunde · 2019Article
Corrections and comments
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Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivePrevious trials have shown little benefit for preventing preterm birth in twin pregnancies using 90-200 mg of daily vaginal natural progesterone. Higher doses have not been tested. Our aim was to determine the efficacy and safety of two different daily doses of vaginal natural progesterone (200 and 400 mg), compared with placebo, for preventing preterm birth in unselected twin pregnancies.
designRandomised controlled double-blind multicentre trial (1:1:1).
settingThe study was carried out in five university centres from Valencia, Murcia and Alicante (Spain). POPULATION: Women with dichorionic diamniotic twin pregnancies.
methodsThe women self-inserted two vaginal pessaries daily, containing placebo (n = 96), 200 mg of natural progesterone (n = 97) or 400 mg of natural progesterone (n = 97), from 20 to 34 weeks of gestation or delivery. Randomisation was performed by an external centre. Data were analysed on an intention-to-treat basis.
main outcome measurePreterm birth rate.
resultsThe baseline characteristics for placebo and progesterone groups were similar. Comparison of the three groups and analysis of progesterone-treated versus untreated women showed similar pregnancy and neonatal outcomes. The proportion of preterm and very preterm births, low birthweight, perinatal mortality and neonatal morbidity showed no differences between the three groups. Similar results were also obtained when comparing the 200- versus 400-mg progesterone groups. No serious adverse effects were encountered.
conclusionsVaginal progesterone therapy was generally well tolerated, but failed to prevent preterm births in unselected dichorionic diamniotic twin pregnancies. The 400-mg progesterone dose offered no advantages over the 200-mg regimen.
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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.