drugset / Trial / NCT02888041

Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?

NCT02888041

Phase 3 Terminated 160 enrolled University Hospital, Limoges
RandomizedParallel-groupOpen-labelTreatment

Summary

According perinatal surveys, induction of labor is performed at more than 20% of pregnant women. According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®). The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries. Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses. Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.

Timeline

Start
2016-12
Primary completion
2022-04-23
Completion
2022-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 10 mg Other
Comparator Oxytocin Peptide 5 unknown