University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Location status: Recruiting
NCT Number: NCT06199154
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Early Phase 1
Baltimore, Maryland, 21201, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive with 25 mcg or 50 mcg vaginal misoprostol every 4 hours.
Time frame: Start of IOL until complete dilation
Time frame: Start of IOL until complete dilation
Time frame: Start of IOL until 6 cm dilation
Time frame: Start of IOL until 6 cm dilation
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Maternal or Fetal
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until delivery
Time frame: Start of IOL until discharge, assessed up to 4 days
Time frame: Start of IOL until postpartum day 4
Time frame: Start of IOL until discharge or day of life 30
Contact information is provided by the study sponsor or research team.
Krista Mehlhaff, DO
CONTACT
Rosa Drummond, MD
CONTACT
University of Maryland, Baltimore
Other
Induction of Labor in Morbidly Obese Patients: Comparison of 50 mcg and 25 mcg Misoprostol - A Randomized Control Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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