CompletedPhase 4

Misoprostol Dosing in BMI Greater Than 30

United States180 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean)

Timeframe: From baseline to the time of delivery (baseline is initiation of labor induction), up to 3 days

Trial details

NCT IDNCT05262738

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-14

Results submitted2024-05-16

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