Induction of Labor in Morbidly Obese Patients

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different doses of a medication called Misoprostol can help start labor in women who are morbidly obese (defined as having a body mass index, or BMI, of 40 or higher). The researchers want to find out if using a lower or higher dose of this medication can improve the chances of a vaginal delivery instead of needing a cesarean section, which is a surgical procedure to deliver the baby. This is important because reducing the need for surgery can lower health risks for both the mother and baby.

To participate in this trial, women must be at least 18 years old, speak English or Spanish, and be morbidly obese at the time they are admitted for labor induction. They should be between 34 and 42 weeks pregnant with a single baby in a head-down position, and their cervix should be less than 5 centimeters open. Participants can expect to receive either the lower or higher dose of Misoprostol and will be monitored throughout the process. It’s important to note that certain health conditions, previous surgeries, or complications with the pregnancy could make someone ineligible to participate.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
• • Speaks English or Spanish
• • Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
• • Age 18 years old or older
• • Viable, single, cephalic fetus
• • Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm
• • Contractions \< 5 per 10 minutes
• Exclusion Criteria:
• • History of cesarean delivery
• • Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
• • Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
• • Contraindications to labor (cardiac, neurosurgical, need for cesarean)
• • Age \< 18yo
• • Fetal growth restriction with abnormal umbilical artery Doppler indices
• • Cervical dilation \>5 cm
• • Contractions \>5 per 10 minutes
• • Significant vaginal bleeding with concern for placental abruption
• • Non-reassuring fetal status or fetal heart rate decelerations
• • Fetal demise or major fetal anomaly
• • Inability to give consent