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

NCT05857059 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-10-24

No results posted yet for this study

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.

Conditions

  • Labor, Induced
  • Obesity
  • Pregnancy
  • Cesarean Section

Interventions

DRUG

Misoprostol 25 mcg

Misoprostol 50 mcg every 2 hours

DRUG

Misoprostol 50 mcg

Misoprostol 50 mcg every 2 hours

Sponsors & Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857059 on ClinicalTrials.gov