← Back to Search

Prostaglandin E1 Analog

50 Micrograms Vaginal Misoprostol (Intervention) for Prolonged Labor (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 following delivery, through study completion which is estimated at 1 year.
Awards & highlights

MD30 RCT Trial Summary

This trial is testing whether a higher dose of the drug misoprostol may help reduce the time from induction to delivery in obese women.

Eligible Conditions
  • Prolonged Labor
  • Obesity
  • Pregnancy

MD30 RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed following delivery, through study completion which is estimated at 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed following delivery, through study completion which is estimated at 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interval time from labor induction initiation to delivery (vaginal or cesarean)
Secondary outcome measures
Composite Maternal Morbidity (ICU admission, Sepsis, Need for Transfusion, Death)
Composite Neonatal Morbidity (ICU admission, APGAR <=7 at 5 minutes, Sepsis, Acidemia identified upon cord collection (pH < 7.15, Base Deficit >12.0 mmol), Induced Hypothermia, Perinatal Death)
Indication for Cesarean Delivery (if applicable)
+21 more

MD30 RCT 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
350 Previous Clinical Trials
80,804 Total Patients Enrolled
Lorie Harper, MD, MSCIStudy DirectorDivision Chief, Maternal-Fetal Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment ongoing at the present time?

"The research team is actively recruiting participants for this trial, first posted on June 1st 2022 and most recently updated on the 2nd."

Answered by AI

To what extent could 50 Micrograms Vaginal Misoprostol (Intervention) be detrimental to individuals?

"Our assessment at Power yielded a score of 3 for the safety of 50 Micrograms Vaginal Misoprostol, as this interventional treatment has already been approved and is in its fourth phase."

Answered by AI

What is the aggregate population that has enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical examination is presently enrolling individuals who meet the criteria set forth by the team of researchers; it was initially posted on June 1st 2022 and its details were last updated on June 2nd 2022. The trial aims to recruit 180 participants from a single research facility."

Answered by AI
Recent research and studies
International Journal of AndrologyJournal
Fertility and Abortion Rates in the United States, 1960-2002
Hamilton, Brady E., and Stephanie J. Ventura. 2006. “Fertility and Abortion Rates in the United States, 1960-2002”. International Journal of Andrology. Wiley. doi:10.1111/j.1365-2605.2005.00638.x.
The Journal of Maternal-Fetal & Neonatal MedicineJournal
Contraction Frequency After Administration of Misoprostol in Obese Versus Nonobese Women
Stefely, Erin, and Carri R. Warshak. 2018. “Contraction Frequency After Administration of Misoprostol in Obese Versus Nonobese Women”. The Journal of Maternal-fetal & Neonatal Medicine. Informa UK Limited. doi:10.1080/14767058.2018.1465919.
Frontiers in PharmacologyJournal
Health Economic Modeling to Assess Short-term Costs of Maternal Overweight, Gestational Diabetes, and Related Macrosomia €“ a Pilot Evaluation
Lenoir-Wijnkoop, Irene, Eline M. van der Beek, Johan Garssen, Mark J. C. Nuijten, and Ricardo D. Uauy. 2015. “Health Economic Modeling to Assess Short-term Costs of Maternal Overweight, Gestational Diabetes, and Related Macrosomia €“ a Pilot Evaluation”. Frontiers in Pharmacology. Frontiers Media SA. doi:10.3389/fphar.2015.00103.
American Journal of Obstetrics and GynecologyJournal
Defining Failed Induction of Labor
Grobman, William A., Jennifer Bailit, Yinglei Lai, Uma M. Reddy, Ronald J. Wapner, Michael W. Varner, John M. Thorp Jr., et al.. 2018. “Defining Failed Induction of Labor”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2017.11.556.
~64 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top