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Anti-metabolites

Misoprostol for Labor Induction in Obese Pregnant Women

Phase < 1

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Morbidly obese (BMI ≥ 40 kg/m2) at admission for induction of labor

Age 18 years old or older

Must not have

Contraindications to labor (cardiac, neurosurgical, need for cesarean)

Contraindication to prostaglandin administration (significant myomectomy, prior cesarean delivery)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of iol until delivery

Awards & highlights

Summary

This trial aims to compare two different doses of Misoprostol (25 mcg vs 50 mcg) to see which one is more effective in inducing labor in severely obese patients. The goal

Who is the study for?

This trial is for morbidly obese pregnant women with a BMI of 40 or higher. They must be between 34 and 42 weeks along, over 18 years old, carrying one baby in the head-down position, and have less than five contractions per ten minutes. Women who don't speak English or Spanish or have other health conditions that could interfere are not eligible.

What is being tested?

The study is testing two different doses of Misoprostol (25 mcg vs. 50 mcg) to see which is more effective at starting labor in morbidly obese women to potentially reduce the need for cesarean delivery by improving rates of vaginal birth.

What are the potential side effects?

Misoprostol may cause side effects like stomach pain, diarrhea, headache, nausea, vomiting, fever or chills. In rare cases it can lead to excessive uterine contractions which might affect the baby's heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am morbidly obese with a BMI of 40 or higher.

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I am 18 years old or older.

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I am pregnant with one baby in the head-down position.

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My pregnancy is between 34 and 42 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have health conditions that make natural childbirth risky.

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I cannot take prostaglandins due to a major surgery like a C-section.

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I cannot have a vaginal delivery due to specific health reasons.

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I am experiencing severe vaginal bleeding possibly due to placental issues.

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I am unable to understand and give consent for treatment.

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I am under 18 years old.

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My baby has shown signs of distress during pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of iol until delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of iol until delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of iol until delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Indication for cesarean delivery

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765

Blood transfusion

100%

80%

60%

40%

20%

Study treatment Arm

Oral Misoprostol-Mothers

Oxytocin-Mothers

Oral Misoprostol-Fetus/Neonate

Oxytocin-Fetus/Neonate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - 50 mcg vaginal misoprostolExperimental Treatment1 Intervention

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Group II: Control - 25 mcg vaginal misoprostolActive Control1 Intervention

Participants will receive 25 mcg vaginal misoprostol every 4 hours.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Misoprostol

2008

Completed Phase 4

~3340

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

705 Previous Clinical Trials

378,298 Total Patients Enrolled

~108 spots leftby May 2025

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