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

Not Applicable

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Misoprostol

• Registration Number: NCT03748147
• Lead Sponsor: University of Cincinnati

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-02-22
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study First Posted: 2018-11-20
• Last Update Posted: 2018-11-20
• Study Start: 2018-12-10
• Primary Completion: 2020-06-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Misoprostol	Misoprostol 50 mcg po every four hours
Control	Misoprostol	Standard of care, misoprostol 25 mcg po every four hours

Primary Outcome Measures

Name	Time	Method
Vaginal delivery	Variable, but within 4 days	Successful induction defined as a vaginal delivery following labor induction.

Secondary Outcome Measures

Name	Time	Method
Completed cervical ripening	2 days	Bishop score of greater than 7 (Bishop score designated per protocol based upon cervical dilation, effacement, station, consistency and position).
Rate of tachysystole, fetal nonreassuring status, uterine rupture	3 days	Rate of the following as categorical variables: tachysystole (any delay in study medication administration for greater than 5 contractions/10 minute window), non-reassuring fetal status (any evaluation of the fetal tracing that leads to delays in study drug administration secondary to concerns for the fetal status), NICU admission, uterine rupture
Specific time interval from start of induction to active labor	2 days	We will measure the interval (hours) between start of cervical ripening and active labor defined as reaching a cervical dilation of 6 cm.