Misoprostol for Induction of Labor in Obese Women: Comparison Between 25 and 50 mcg Oral Administration
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Centro Hospitalar e Universitário de Coimbra, E.P.E.