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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard of care, misoprostol 25 mcg po every four hours | Drug: Misoprostol<br>* prostaglandin e1<br>* Other names: cytotec;|
| Experimental: Intervention<br>Misoprostol 50 mcg po every four hours | Drug: Misoprostol<br>* prostaglandin e1<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal delivery | Successful induction defined as a vaginal delivery following labor induction. | Variable, but within 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completed cervical ripening | Bishop score of greater than 7 (Bishop score designated per protocol based upon cervical dilation, effacement, station, consistency and position). | 2 days | 
| Specific time interval from start of induction to active labor | We will measure the interval (hours) between start of cervical ripening and active labor defined as reaching a cervical dilation of 6 cm. | 2 days | 
| Rate of tachysystole, fetal nonreassuring status, uterine rupture | 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 | 3 days |