drugset / Trial / NCT04413890

Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor

NCT04413890

Phase 2 Completed 268 enrolled University Hospital Center of Martinique
RandomizedParallel-groupOpen-labelTreatment

Summary

The study compares two rhythms of administration of prostaglandin vaginal gels for cervical priming before induction of labor in term patients. In our institution, prostaglandin gels are given for a maximum of three times, with induction by oxytocin and amniotomy the day after the last gel whatever Bishop score has been obtained. This management results in some patient spending four days in hospital before delivery. The aim of the study is to compare our classical management scheme with a reduced interval between to gels, of 12h instead of 24 h. The primary outcome will be the time elapsed between the first prostaglandin gel and delivery. Tolerance of both management patterns will also be evaluated through a satisfaction survey.

Timeline

Start
2019-12-17
Primary completion
2021-01-27
Completion
2021-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 0.5 mg Other
Subject Dinoprostone Other / unclassified 1 mg Other
Subject Dinoprostone Other / unclassified 2 mg Other

Indications