RECRUITING

Induction of Labor in Morbidly Obese Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-15
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06199154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor
  2. * Speaks English or Spanish
  3. * Gestational age between 34 weeks and 0 days and 42 weeks and 6 days
  4. * Age 18 years old or older
  5. * Viable, single, cephalic fetus
  6. * Intent to proceed with cervical ripening - cervical exam: dilation \< 5 cm
  7. * Contractions \< 5 per 10 minutes
  1. * History of cesarean delivery
  2. * Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)
  3. * Contraindication to vaginal delivery (placenta previa, vasa previa, HIV with high viral load)
  4. * Contraindications to labor (cardiac, neurosurgical, need for cesarean)
  5. * Age \< 18yo
  6. * Fetal growth restriction with abnormal umbilical artery Doppler indices
  7. * Cervical dilation \>5 cm
  8. * Contractions \>5 per 10 minutes
  9. * Significant vaginal bleeding with concern for placental abruption
  10. * Non-reassuring fetal status or fetal heart rate decelerations
  11. * Fetal demise or major fetal anomaly
  12. * Inability to give consent

Contacts and Locations

Study Contact

Rosa Drummond, MD
CONTACT
4103285965
rosa.drummond@umm.edu
Krista Mehlhaff, DO
CONTACT
4103285965
KMehlhaff@som.umaryland.edu

Study Locations (Sites)

University of Maryland Medical Center
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15
Study Completion Date2025-10

Study Record Updates

Study Start Date2024-07-15
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • induction of labor
  • morbid obesity
  • misoprostol

Additional Relevant MeSH Terms

  • Morbid Obesity
  • Pregnancy