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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
prostaglandin e1
Vaginal delivery
Successful induction defined as a vaginal delivery following labor induction.
Time frame: Variable, but within 4 days
Completed cervical ripening
Bishop score of greater than 7 (Bishop score designated per protocol based upon cervical dilation, effacement, station, consistency and position).
Time frame: 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.
Time frame: 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
Time frame: 3 days
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