Obesity Study to Assess Induction of Labor

Induction of Labor Affected Fetus / Newborn Clinical Trial

— Obtainable  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03796416
• Other study ID #: HP-00077208
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: July 2025

Study information

• Verified date: March 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Morbidly obese patient (BMI=40kg/m2) at admission for induction of labor Speaks English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation <4cm and Bishop score 6 or less Contractions < 2 per 10 minutes

Exclusion Criteria:

• History of cesarean delivery Maternal contraindications to labor Fetal contraindications to labor Maternal age <18yo Fetal growth restriction with abnormal umbilical artery Doppler indexes Cervical dilation =4cm or Bishop score =7 Contractions =3 per 10 minutes Non-reassuring fetal status Latex allergy

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn
• Obesity

Intervention

Drug:
• Misoprostol
used at a rate of 25 mcg Q4hours for cervical ripening.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	achieving complete cervical dilation		24 hours