Comparing mifepristone and misoprostol to misoprostol alone for labor induction in nonviable second trimester pregnancies
Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial
This study is testing if using mifepristone along with misoprostol can help women with nonviable second trimester pregnancies deliver faster than using misoprostol alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05322252 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of administering mifepristone simultaneously with misoprostol for inducing labor in cases of nonviable second trimester pregnancies, compared to using misoprostol alone. The study aims to determine if this combined approach can reduce the total time from diagnosis to delivery, which is critical in minimizing maternal complications. Participants include women aged 18 and older, between 14 and 28 weeks of gestation, with a singleton nonviable fetus requiring labor induction. The trial is conducted at Barnes-Jewish Hospital in Saint Louis, Missouri.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older, between 14 and 28 weeks of gestation, with a singleton nonviable fetus requiring induction of labor.
Not a fit: Patients who plan to undergo surgical evacuation or have contraindications to mifepristone or vaginal delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time to delivery for women facing nonviable pregnancies, thereby decreasing the risk of maternal complications.
How similar studies have performed: Previous studies have shown mixed results regarding the timing of mifepristone administration, making this approach a novel investigation in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * 14 and 28 weeks' gestation * Singleton gestation * Nonviable fetus (i.e. fetal demise or previable gestational age/weight or lethal fetal anomaly) * Requires induction of labor * If fetal cardiac motion, abortion being performed for medical emergency per MO laws and consents completed Exclusion Criteria: * Contraindication to mifepristone * Plan for surgical evacuation of uterus * Contraindication to vaginal delivery * Plan to initiate induction with any medication or device except misoprostol * Declines participation
Where this trial is running
Saint Louis, Missouri
- Barnes-Jewish Hospital — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Katherine H Bligard, MD,MA
- Email: khsmith@wustl.edu
- Phone: 2259542160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.