Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol
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|ClinicalTrials.gov Identifier: NCT03748147|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Induction of Labor Affected Fetus / Newborn||Drug: Misoprostol||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.|
|Official Title:||Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol|
|Estimated Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||March 1, 2021|
Active Comparator: Control
Standard of care, misoprostol 25 mcg po every four hours
Other Name: cytotec
Misoprostol 50 mcg po every four hours
Other Name: cytotec
- Vaginal delivery [ Time Frame: Variable, but within 4 days ]Successful induction defined as a vaginal delivery following labor induction.
- Completed cervical ripening [ Time Frame: 2 days ]Bishop score of greater than 7 (Bishop score designated per protocol based upon cervical dilation, effacement, station, consistency and position).
- Specific time interval from start of induction to active labor [ Time Frame: 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.
- Rate of tachysystole, fetal nonreassuring status, uterine rupture [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748147
|Contact: Carri R Warshak, M.D.||firstname.lastname@example.org|
|Contact: David McKinney, M.D.||email@example.com|