Induction of Labor in Morbidly Obese Patients

NCT ID: NCT06199154

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2026-10-31

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.

Conditions

Morbid Obesity; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control - 25 mcg vaginal misoprostol

Participants will receive 25 mcg vaginal misoprostol every 4 hours.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

Intervention - 50 mcg vaginal misoprostol

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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

Interventions

Misoprostol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosa Drummond, MD

Role: CONTACT

rosa.drummond@umm.edu

4103285965

Krista Mehlhaff, DO

Role: CONTACT

KMehlhaff@som.umaryland.edu

4103285965

Facility Contacts

Rosa Drummond, MD

Role: primary

rosa.drummond@umm.edu

410-328-6436

References

Hoyert, Donna L. "Maternal Mortality Rates in the United States, 2021." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 16 Mar. 2023, www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm.

Reference Type: BACKGROUND

MarchofDimes. "Total Cesarean Deliveries by Maternal Race/Ethnicity: United States, 2019-2021 Average." March of Dimes | PeriStats, www.marchofdimes.org/peristats/data?reg=99&top=8&stop=356&lev=1&slev=1&obj=1. Accessed 14 Nov. 2023.

Reference Type: BACKGROUND

"Adult Obesity Facts." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 17 May 2022, www.cdc.gov/obesity/data/adult.html.

Reference Type: BACKGROUND

Ellis JA, Brown CM, Barger B, Carlson NS. Influence of Maternal Obesity on Labor Induction: A Systematic Review and Meta-Analysis. J Midwifery Womens Health. 2019 Jan;64(1):55-67. doi: 10.1111/jmwh.12935. Epub 2019 Jan 16.

Reference Type: BACKGROUND

PMID: 30648804 (View on PubMed)

Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

Reference Type: BACKGROUND

PMID: 30089070 (View on PubMed)

Beckwith L, Magner K, Kritzer S, Warshak CR. Prostaglandin versus mechanical dilation and the effect of maternal obesity on failure to achieve active labor: a cohort study. J Matern Fetal Neonatal Med. 2017 Jul;30(13):1621-1626. doi: 10.1080/14767058.2016.1220523. Epub 2016 Aug 25.

Reference Type: BACKGROUND

PMID: 27560557 (View on PubMed)

O'Dwyer V, O'Kelly S, Monaghan B, Rowan A, Farah N, Turner MJ. Maternal obesity and induction of labor. Acta Obstet Gynecol Scand. 2013 Dec;92(12):1414-8. doi: 10.1111/aogs.12263.

Reference Type: BACKGROUND

PMID: 24116732 (View on PubMed)

Pevzner L, Powers BL, Rayburn WF, Rumney P, Wing DA. Effects of maternal obesity on duration and outcomes of prostaglandin cervical ripening and labor induction. Obstet Gynecol. 2009 Dec;114(6):1315-1321. doi: 10.1097/AOG.0b013e3181bfb39f.

Reference Type: BACKGROUND

PMID: 19935035 (View on PubMed)

Drummond R, Patel M, Myers M, Ritter A, Hurvitz JA, Goetzinger KR, Crimmins SD. Class III obesity is an independent risk factor for unsuccessful induction of labor. AJOG Glob Rep. 2022 Sep 23;2(4):100109. doi: 10.1016/j.xagr.2022.100109. eCollection 2022 Nov.

Reference Type: BACKGROUND

PMID: 36311296 (View on PubMed)

Other Identifiers

HP-00108436

Identifier Type: -

Identifier Source: org_study_id