A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

Phase 3 Completed 114 enrolled Ferring Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration

Timeline

Start: 2017-04-03
Primary completion: 2018-08-30
Completion: 2018-08-30

Outcome

Met primary endpoint

paper PROPESS 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). PMID 33094550 ↗

Publications

Results Itoh H, Ishii K, Shigeta N, Itakura A, Hamada H, Nagamatsu T, Ishida T, Bungyoku Y, Falahati A, Tomisaka M, Kitamura M. 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. J Obstet Gynaecol Res. 2021 Jan;47(1):216-225. doi: 10.1111/jog.14472. Epub 2020 Oct 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dinoprostone	Other / unclassified	10 mg	Other