drugset / Trial / NCT05857059

Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration

NCT05857059

RandomizedParallel-groupSingle-blindTreatment

Summary

In recent decades, obesity has become a prevalent issue in Portugal, with 38.6% and 13.8% of the population being overweight or obese, respectively. Obese pregnant women have a higher rate of obstetric complications, including hypertensive complications, gestational diabetes and fetal macrosomia, leading to increased induction of labor (IOL) and cesarean section (CS) rates. To determine the effect of increasing oral misoprostol dose on CS rate in obese pregnant women undergoing IOL, a randomized controlled trial with a sample size of 114 cases in each group was calculated to detect a 15% difference in CS rate. The primary objective is to determine the effect of increasing oral misoprostol dose, with secondary goals being to compare successful IOL rates and their relationship with oral misoprostol dose, as well as to evaluate tolerability and side effects in relation to different doses of oral misoprostol.

Timeline

Start
2019-10-15
Primary completion
2024-05-31
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Misoprostol Other / unclassified 25 ug Oral
Subject Misoprostol Other / unclassified 50 ug Oral