Misoprostol Dosing in BMI Greater Than 30

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas at Austin
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

1. Singleton gestation

2. Age 18 years or older

3. Gestational age >= 36 weeks

4. BMI >= 30 kg/m2 at time of labor induction

5. Cephalic presentation (including successful external cephalic version)

6. Cervical dilation <= 3cm

7. Intent to proceed with cervical ripening

Exclusion Criteria:

1. Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)

2. Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.)

3. Multiple gestations

4. Gestational age < 36 weeks

5. Non-reassuring fetal heart tracing

6. Evidence of clinical chorioamnionitis

7. Significant vaginal bleeding with concern for abruption

8. Prior cesarean delivery or uterine surgery

9. Major fetal anomaly or demise

10. Cervix >3cm

11. No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)

12. Uterine tachysystole (defined as >= 5 contractions within a 10m period)

13. Fetal Growth Restriction (EFW <= 5% or elevated/absent/reversed Umbilical Artery dopplers)

14. Inability to give consent (inability to read/write in English or Spanish)