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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03748147
• Other study ID #: 2016-4435
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2018
• Source: University of Cincinnati
• Contact: Carri R Warshak, M.D.
• Phone: 513-558-8448
• Email: eaglercr[@]ucmail.uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• Misoprostol
prostaglandin e1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery	Successful induction defined as a vaginal delivery following labor induction.	Variable, but within 4 days
Secondary	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
Secondary	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
Secondary	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