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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard of care, misoprostol 25 mcg po every four hours |
|
| Intervention | Experimental | Misoprostol 50 mcg po every four hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | prostaglandin e1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal delivery | Successful induction defined as a vaginal delivery following labor induction. | Variable, but within 4 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy, Study of labor induction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carri R Warshak, M.D. | Contact | 513-558-8448 | eaglercr@ucmail.uc.edu | |
| David McKinney, M.D. | Contact | 513-558-8448 | mckinndi@ucmail.uc.edu |
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Would consider upon request.
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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Parallel design randomized trial. Two study groups: control (25 mcg) intervention (50 mcg)
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Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.
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 |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |