NCT06199154

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for early_phase_1

Timeline
5mo left

Started Jul 2024

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2024Oct 2026

First Submitted

Initial submission to the registry

December 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

December 4, 2023

Last Update Submit

July 2, 2025

Conditions

Morbid ObesityPregnancy

Keywords

induction of labormorbid obesitymisoprostol

Outcome Measures

Primary Outcomes (1)

  • Achievement of complete cervical dilation

    Start of IOL until complete dilation

Secondary Outcomes (16)

  • Time interval from start of induction of labor (IOL) to complete cervical dilation

    Start of IOL until complete dilation

  • Achievement of 6 cm cervical dilation/active labor

    Start of IOL until 6 cm 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

  • +11 more secondary outcomes

Study Arms (2)

Control - 25 mcg vaginal misoprostol

ACTIVE COMPARATOR

Participants will receive 25 mcg vaginal misoprostol every 4 hours.

Drug: Misoprostol

Intervention - 50 mcg vaginal misoprostol

EXPERIMENTAL

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Drug: Misoprostol

Interventions

MisoprostolDRUG

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

Control - 25 mcg vaginal misoprostolIntervention - 50 mcg vaginal misoprostol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (9)

  • 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.

    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.

    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.

    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.

    PMID: 30648804BACKGROUND

  • 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.

    PMID: 30089070BACKGROUND

  • 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.

    PMID: 27560557BACKGROUND

  • 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.

    PMID: 24116732BACKGROUND

  • 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.

    PMID: 19935035BACKGROUND

  • 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.

    PMID: 36311296BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Rosa Drummond, MD

CONTACT

4103285965rosa.drummond@umm.edu

Krista Mehlhaff, DO

CONTACT

4103285965KMehlhaff@som.umaryland.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

January 10, 2024

Study Start

July 15, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)