Trial reportThe journal of obstetrics and gynaecology research2021
Efficacy and safety of controlled-release dinoprostone vaginal delivery system (PROPESS) in Japanese pregnant women requiring cervical ripening: Results from a multicenter, randomized, double-blind, placebo-controlled phase III study.
Trial report in The journal of obstetrics and gynaecology research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03067727 (A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term), which is not on this map. Cited by 16 papers.
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 Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (41 Weeks of Gestation) Requiring Cervical Ripening
Who cites it
16 citing papers in PubMed, 28 citations in OpenAlex.
- The Bishop Index and Birth Outcomes in Nulliparous Women Undergoing Labor Induction: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- Delivery Outcomes in the First 3 Years Following the Clinical Introduction of the Dinoprostone Vaginal Insert in Japan.The journal of obstetrics and gynaecology research · 2026Article
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- Article
- Ultrasound-guided insertion of controlled-release dinoprostone vaginal delivery system (PROPESS).Journal of medical ultrasonics (2001) · 2025Article
- Timing of Prostin E2 Administration After Poor Response to Propess: Impact on Induction-to-Birth Interval and Maternal/Neonatal Outcomes.Medicina (Kaunas, Lithuania) · 2025Article
- Article
- Safety of the use of dinoprostone gel and vaginal insert for induction of labor: A multicenter retrospective cohort study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Observational
- Effect of vaginal pH on the efficacy of the dinoprostone vaginal insert for cervical ripening in patients with an unfavorable bishop score.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025Observational
- Clozapine treatment of a Japanese patient during pregnancy: Effect on fetal heart rate.Neuropsychopharmacology reports · 2024Article
- Efficacy of controlled-release dinoprostone vaginal insert for elective induction of labor before due date.The journal of obstetrics and gynaecology research · 2024Article
- The effect of slow-release vaginal dinoprostone on maternal and fetal oxidative stress in term pregnancies complicated by oligohydramnios: Prospective cohort study.Journal of the Chinese Medical Association : JCMA · 2024Article
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- Article
- Comparison of the Dinoprostone Vaginal Insert and Dinoprostone Tablet for the Induction of Labor in Primipara: A Retrospective Cohort Study.Journal of clinical medicine · 2022Article
- The Successful Use of Nitroglycerin for Uterine Hyperstimulation with Fetal Heart Rate Abnormality Caused by a Controlled-Release Dinoprostone Vaginal Delivery System (PROPESS): A Case Report.Medicina (Kaunas, Lithuania) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 8 institutions in 1 country.
Funding
Abstract
aimTo evaluate the efficacy and safety of dinoprostone vaginal insert (PROPESS) in pregnant post-term Japanese women requiring cervical ripening.
methodsThis randomized, double-blind, placebo-controlled study included 114 pregnant Japanese women at term (41 weeks of gestation) requiring cervical ripening (baseline Bishop score (BS) ≤ 4). The primary end-point was the proportion of subjects with successful cervical ripening defined as BS ≥ 7 or vaginal delivery in 12 h. The secondary end-points were changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs.
resultsPROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002). The median time from administration to vaginal delivery was significantly shorter in the PROPESS group than in the placebo group (26.18 h vs 33.02 h; OR 2.51; 95% CI [1.60-3.92]; P < 0.0001). In the PROPESS group, the dosage of uterotonic drugs, such as oxytocin, decreased, and the number of patients who used these drugs also decreased.
conclusionPROPESS administration for a maximum of 12 h was an effective and well-tolerated treatment for pregnant Japanese women post-term requiring cervical ripening.
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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.