Induction of Labor in Morbidly Obese Patients

University of Maryland Baltimore (UMB)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Morbid Obesity; Pregnancy

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT06199154

HP-00108436

Details and patient eligibility

About

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.

Full description

The rate of IOL continues to increase, from about 10% in 1990 to 23% in 2018. Patients with BMI >40 are at increased risk for failed IOL and needing a CD. Studies show that morbidly obese patients require higher doses of pitocin and multiple agents to achieve vaginal delivery, but optimal dosing of misoprostol has not been studied as well. Increasing the rate of vaginal delivery in this population will help decrease risk of surgical morbidity.

The investigators plan to conduct a randomized controlled double blinded trial. Patients who are scheduled for induction of labor after 34 weeks gestation, have a BMI >40, and meet all study inclusion criteria will be approached by research personnel during their outpatient appointments. Participants will be randomized to either receive 25 mcg vaginal misoprostol every 4 hours or 50 mcg vaginal misoprostol every 4 hours.

Enrollment: 162 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups

Control - 25 mcg vaginal misoprostol

Active Comparator group

Description:

Participants will receive 25 mcg vaginal misoprostol every 4 hours.

Treatment:

Drug: Misoprostol

Intervention - 50 mcg vaginal misoprostol

Experimental group

Description:

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Treatment:

Drug: Misoprostol