Status:
COMPLETED
Misoprostol Dosing in BMI Greater Than 30
Lead Sponsor:
University of Texas at Austin
Conditions:
Pregnancy Related
Obesity
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
As of 2019, almost 1 in 4 women in the United States had their labor induced with almost 9 in 10 women requiring different methods to prepare their cervix for induction. There have been several resear...
Eligibility Criteria
Inclusion
- Singleton gestation
- Age 18 years or older
- Gestational age \>= 36 weeks
- BMI \>= 30 kg/m2 at time of labor induction
- Cephalic presentation (including successful external cephalic version)
- Cervical dilation \<= 3cm
- Intent to proceed with cervical ripening
Exclusion
- Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)
- Contraindication to prostaglandin administration (significant allergy, prior cesarean delivery, etc.)
- Multiple gestations
- Gestational age \< 36 weeks
- Non-reassuring fetal heart tracing
- Evidence of clinical chorioamnionitis
- Significant vaginal bleeding with concern for abruption
- Prior cesarean delivery or uterine surgery
- Major fetal anomaly or demise
- Cervix \>3cm
- No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)
- Uterine tachysystole (defined as \>= 5 contractions within a 10m period)
- Fetal Growth Restriction (EFW \<= 5% or elevated/absent/reversed Umbilical Artery dopplers)
- Inability to give consent (inability to read/write in English or Spanish)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05262738
Start Date
June 1 2022
End Date
July 17 2023
Last Update
July 3 2024
Active Locations (1)
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1
University of Texas at Austin Dell Medical School, Department of Women's Health
Austin, Texas, United States, 78705