RecruitingEarly Phase 1NCT06199154

Induction of Labor in Morbidly Obese Patients

Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial


Sponsor

University of Maryland, Baltimore

Enrollment

162 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
  • Speaks English or Spanish
  • Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
  • Age 18 years old or older
  • Viable, single, cephalic fetus
  • Intent to proceed with cervical ripening - cervical exam: dilation < 5 cm
  • Contractions < 5 per 10 minutes

Exclusion Criteria12

  • History of cesarean delivery
  • Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
  • Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
  • Contraindications to labor (cardiac, neurosurgical, need for cesarean)
  • Age < 18yo
  • Fetal growth restriction with abnormal umbilical artery Doppler indices
  • Cervical dilation >5 cm
  • Contractions >5 per 10 minutes
  • Significant vaginal bleeding with concern for placental abruption
  • Non-reassuring fetal status or fetal heart rate decelerations
  • Fetal demise or major fetal anomaly
  • Inability to give consent

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Interventions

DRUGMisoprostol

Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.


Locations(1)

University of Maryland Medical Center

Baltimore, Maryland, United States

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NCT06199154


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