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Antiprogestin

Mifepristone + Misoprostol for Second Trimester Miscarriage (MIST Trial)

Phase 4
Recruiting
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
14 and 28 weeks' gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during admission
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is researching whether giving mifepristone and misoprostol together can reduce labor time in nonviable second trimester pregnancies, reducing risk of maternal complications.

Who is the study for?
This trial is for adults over 18 who are between 14 and 28 weeks pregnant with a single nonviable fetus, meaning the fetus has passed away or cannot survive due to its gestational age/weight or a fatal condition.
What is being tested?
The study is testing if taking Mifepristone and Misoprostol at the same time offers any benefits compared to just Misoprostol alone in inducing labor when dealing with a nonviable second trimester pregnancy.
What are the potential side effects?
Possible side effects of Mifepristone and Misoprostol may include cramping, bleeding, nausea, vomiting, diarrhea, headache, dizziness, fever or chills. The intensity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am between 14 and 28 weeks pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Delivery within 12 hours
Secondary study objectives
Delivery within 24 hours
Diagnosis of clinical chorioamnionitis
Failed induction of labor
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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: Simulatenous mifepristone and misoprostolExperimental Treatment2 Interventions
Participants will receive a dose of 200mg oral mifepristone at time of induction with misoprostol
Group II: Misoprostol aloneActive Control1 Intervention
Participants will have labor induced with misoprostol alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mifepristone
FDA approved
Misoprostol
FDA approved

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,988 Previous Clinical Trials
2,295,604 Total Patients Enrolled
5 Trials studying Aneurysm
171 Patients Enrolled for Aneurysm

Media Library

Mifepristone (Antiprogestin) Clinical Trial Eligibility Overview. Trial Name: NCT05322252 — Phase 4
Aneurysm Research Study Groups: Misoprostol alone, Simulatenous mifepristone and misoprostol
Aneurysm Clinical Trial 2023: Mifepristone Highlights & Side Effects. Trial Name: NCT05322252 — Phase 4
Mifepristone (Antiprogestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05322252 — Phase 4
~0 spots leftby Dec 2024
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