NCT05262738

Misoprostol Dosing in BMI Greater Than 30

Misoprostol Dosing in BMI Greater Than 30: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

Detailed description

As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several research studies in the past designed to look at the fastest and safest method for labor induction, however very few studies have been done in women with a Body Mass Index (BMI) greater than or equal to 30 kg/m2. Women with a BMI greater than or equal to 30 kg/m2, also classified as Obesity, are known to have longer labor induction times and experience more "failed" labor inductions requiring cesarean delivery (C-Sections). Obese women are also at a higher risk of developing complications during labor and postpartum such as excessive vaginal bleeding and infections. Due to limited information, the American College of Obstetricians and Gynecologists (ACOG) currently recommends a standard dosing of 25 or 50 micrograms of vaginal misoprostol for labor induction in all women. However, there are studies which specifically compared the 25 microgram and 50 microgram misoprostol doses and found that women have significantly shorter time to deliveries without any harmful effects to mother or baby. The investigators will conduct a randomized controlled trial to determine if 50 micrograms of vaginal misoprostol, when compared to the standard 25 micrograms, reduces the time from the start of labor induction to delivery in obese women. Women who are admitted to Labor \& Delivery for the purposes of labor induction will be randomized to undergo either 25 micrograms or 50 micrograms of vaginal misoprostol for cervical ripening. Women and their infants will be followed until the time of their discharge.

Conditions

• Pregnancy Related
• Obesity
• Labor Onset and Length Abnormalities

Interventions

Type	Name	Description
DRUG	50 Micrograms Vaginal Misoprostol (Intervention)	Subjects will undergo cervical ripening with 50 micrograms of vaginal misoprostol every 4 hours.
DRUG	25 Micrograms Vaginal Misoprostol (Control)	Subjects will undergo cervical ripening with 25 micrograms of vaginal misoprostol every 4 hours.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-07-14
• Completion: 2023-07-17
• First posted: 2022-03-02
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study