Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol

University of Cincinnati

Status: Unknown

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03748147

2016-4435

Details and patient eligibility

About

This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.

Full description

We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.

Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Labor induction, BMI of 30 or greater, English speaking

Exclusion criteria

• Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard of care, misoprostol 25 mcg po every four hours

Treatment:

Drug: Misoprostol

Intervention

Experimental group

Description:

Misoprostol 50 mcg po every four hours

Treatment:

Drug: Misoprostol