Induction of Labor Affected Fetus / Newborn
Conditions
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.
Interventions
DRUGMisoprostol
prostaglandin e1
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.
Intervention model description
Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal delivery | Variable, but within 4 days | Successful induction defined as a vaginal delivery following labor induction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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 |
Contacts
Primary ContactCarri R Warshak, M.D.
Backup ContactDavid McKinney, M.D.
Outcome results
None listed