NCT03796416

Obesity Study to Assess Induction of Labor

Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

There are more and more pregnant women who are obese. It is very difficult for obese women to get into labor. That is why when women are obese, half are likely to need a Cesarean delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may be a combination of issues that cause obese women to need C-sections. We believe one of those reasons is that the womb of obese women respond differently to medications and devices compared to non-obese women. There are commonly two ways to help women get into labor. One way is a medication called misoprostol. The second way is a device called Foley balloon. In most studies, both ways are equally effective in helping women get into labor. However, these studies included everyone, and didn't focus on obese women. So far there are no studies in this area that focus only on obese women. Therefore we need to design this study to focus just on obese women and what is the best way to help them get into labor and avoid a C-section.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DRUG	Misoprostol	used at a rate of 25 mcg Q4hours for cervical ripening.

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-01-01
• Completion: 2025-07-01
• First posted: 2019-01-08
• Last updated: 2022-03-22