Viewing Study NCT03796416



Ignite Creation Date: 2024-05-06 @ 12:35 PM
Last Modification Date: 2024-10-26 @ 1:01 PM
Study NCT ID: NCT03796416
Status: WITHDRAWN
Last Update Posted: 2022-03-22
First Post: 2019-01-04

Brief Title: Obesity Study to Assess Induction of Labor
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Obesity Study to Assess Induction of Labor With Balloon and Cytotec a Randomized Control Trial
Status: WITHDRAWN
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: in error
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Obtainable
Brief 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 deliveryC-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 didnt 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None