drugset / Trial / NCT05430711

Dinoprostone Induction vs. Expectant Management After PROM at Term

NCT05430711

Phase 4 Unknown 70 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupOpen-labelTreatment

Summary

Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined. The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.

Timeline

Start
2022-06
Primary completion
2023-06
Completion
2023-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 10 mg Other