Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199154
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-12-04
Brief Title:
Induction of Labor in Morbidly Obese Patients
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Induction of Labor in Morbidly Obese Patients Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized control trial is to compare different doses of Misoprostol 25 mcg vs 50 mcg in induction of labor IOL in morbidly obese patients with BMI 40 It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery CD If the rates of vaginal delivery in this population can improve then surgical morbidity can be reduced in these patients
Detailed Description:
The rate of IOL continues to increase from about 10 in 1990 to 23 in 2018 Patients with BMI 40 are at increased risk for failed IOL and needing a CD Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery but optimal dosing of misoprostol has not been studied as well Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity
The investigators plan to conduct a randomized controlled double blinded trial Patients who are scheduled for induction of labor after 34 weeks gestation have a BMI 40 and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours
The investigators plan to conduct a randomized controlled double blinded trial Patients who are scheduled for induction of labor after 34 weeks gestation have a BMI 40 and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None