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

Launched by CENTRO HOSPITALAR E UNIVERSITÁRIO DE COIMBRA, E.P.E. · May 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different doses of a medication called misoprostol on inducing labor in obese pregnant women. Specifically, researchers want to compare the outcomes of giving either 25 micrograms (mcg) or 50 mcg of oral misoprostol to see which dose is more effective in reducing the need for cesarean sections during labor. The trial is taking place in Portugal, where a significant number of women are affected by obesity, and it aims to improve labor induction practices for this group.

To participate in the trial, women must have a body mass index (BMI) of 30 or higher, be pregnant with a single baby that is positioned head-down, and have a medical reason for needing labor induction. They also need to have a specific score indicating that their cervix is not yet ready for labor. Women who are underweight, have multiple pregnancies, or have certain medical conditions will not be eligible. Participants can expect to receive either the lower or higher dose of misoprostol and will be monitored for how well the induction works and any side effects they may experience. This study could help improve outcomes for obese women during labor and delivery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • BMI ≥ 30 kg/m2 recorded based on maternal weight at preconception or in the first trimester
• • Singleton live gestation with vertex presentation
• • Pregnancies followed in our institution with sonographic confirmation of gestational age in the first trimester
• • Obstetrical indication for labor induction
• • Bishop score of \<5 at the time of induction of labor
• Exclusion Criteria:
• • Underweight and normal weight women (BMI \<30 kg/m2)
• • Known hypersensitivity to prostaglandins
• • Preterm gestations (\< 37 weeks)
• • Multiple gestation
• • Women who cannot give their informed consent
• • Contraindications for vaginal delivery
• • Previous c-section or uterine scar due to previous gynecological surgery
• • Maternal or fetal pathology (for example: fetal indications: non-reassuring fetal status - intra-uterine growth restriction with abnormal umbilical doppler, abnormal fetal cardiac rhythm; stillbirth; or maternal/pregnancy related indications such as placenta previa)