Induction of Labor in Morbidly Obese Patients
- Registration Number
- NCT06199154
- Lead Sponsor
- University of Maryland, Baltimore
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 162
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention - 50 mcg vaginal misoprostol Misoprostol Participants will receive 50 mcg vaginal misoprostol every 4 hours. Control - 25 mcg vaginal misoprostol Misoprostol Participants will receive 25 mcg vaginal misoprostol every 4 hours.
- Primary Outcome Measures
Name Time Method Achievement of complete cervical dilation Start of IOL until complete dilation
- Secondary Outcome Measures
Name Time Method Number of patients with tachysystole Start of IOL until delivery Achievement of 6 cm cervical dilation/active labor Start of IOL until 6 cm dilation Incidence of cesarean deliveries Start of IOL until delivery Cervical exam at time of cesarean delivery Start of IOL until delivery Number of patients with chorioamnionitis Start of IOL until delivery Number of patients with postpartum hemorrhage Start of IOL until discharge, assessed up to 4 days Time interval from start of induction of labor (IOL) to complete cervical dilation Start of IOL until complete dilation Time interval from start of IOL to 6 cm cervical dilation/active labor Start of IOL until 6 cm dilation Time interval from start of IOL to vaginal delivery Start of IOL until delivery Time interval from start of IOL to delivery Start of IOL until delivery Incidence of vaginal deliveries Start of IOL until delivery Number of patients requiring terbutaline Start of IOL until delivery Indication for cesarean delivery Start of IOL until delivery Maternal or Fetal
Number of patients with tachysystole with non reassuring fetal heart rate (NRFHT) Start of IOL until delivery Composite neonatal morbidity (NICU admission, Apgar score =<7 at 5 minutes, sepsis, cord gas arterial pH <7.10 and/or base deficit < -12, active cooling protocol, death) Start of IOL until discharge or day of life 30 Composite maternal morbidity (need for transfusion, sepsis, ICU admission, death) Start of IOL until postpartum day 4
Trial Locations
- Locations (1)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States