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Prostaglandin E1 Analog
Misoprostol Dosing in BMI Greater Than 30 (MD30 RCT Trial)
Phase 4
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed postpartum day one following delivery, up to 5 days post-delivery.
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if a higher dose of a labor-inducing medication can speed up delivery in obese women. Obese women often face longer and more complicated labors. The medication helps prepare the cervix for labor, potentially making delivery faster.
Eligible Conditions
- Prolonged Labor
- Obesity
- Pregnancy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed postpartum day one following delivery, up to 5 days post-delivery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed postpartum day one following delivery, up to 5 days post-delivery.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants Exhibiting Uterine Tachysystole
Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations
Patient Satisfaction (Labor Pain Scale, Question 1)
+9 moreSide effects data
From 2023 Phase 4 trial • 180 Patients • NCT0526273819%
postpartum hemorrhage
5%
Neonatal ICU Admission
3%
pRBC transfusion
2%
clinical endometritis
1%
Maternal ICU admission
1%
sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
25 Micrograms Vaginal Misoprostol (Control)
50 Micrograms Vaginal Misoprostol (Intervention)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 50 Micrograms Vaginal Misoprostol (Intervention)Experimental Treatment1 Intervention
Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
Group II: 25 Micrograms Vaginal Misoprostol (Control)Active Control1 Intervention
Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
50 Micrograms Vaginal Misoprostol (Intervention)
2022
Completed Phase 4
~180
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
377 Previous Clinical Trials
86,395 Total Patients Enrolled
Lorie Harper, MD, MSCIStudy DirectorDivision Chief, Maternal-Fetal Medicine