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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
MIST 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.Check my eligibility
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.See study design
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.
MIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am between 14 and 28 weeks pregnant.
MIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delivery within 12 hours
Secondary outcome measures
Delivery within 24 hours
Diagnosis of clinical chorioamnionitis
Failed induction of labor
+3 moreOther outcome measures
Pregnancy related readmission within 30 days
MIST 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
1,937 Previous Clinical Trials
2,299,665 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am between 14 and 28 weeks pregnant.You are pregnant with only one baby.The baby in your womb is no longer alive or has a condition that makes survival impossible.
Research Study Groups:
This trial has the following groups:- Group 1: Misoprostol alone
- Group 2: Simulatenous mifepristone and misoprostol
Awards:
This trial has 5 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are contributing to this medical investigation?
"Indeed, the clinicaltrials.gov database indicates that this research is actively seeking participants; it was first posted on July 1st 2022 and most recently updated April 23rd 2023. The study requires 30 subjects to be recruited from a single site."
Answered by AI
Is registration for this trial currently open?
"Confirming the listing on clinicaltrials.gov, this research endeavor is in its recruitment phase since July 1st 2022 and was most recently updated on April 23rd 2023."
Answered by AI
Could you elucidate the risks associated with using mifepristone and misoprostol in combination?
"Our team at Power assigned a score of 3 to the concurrent use of mifepristone and misoprostol, due to its status as an approved Phase 4 medical treatment."
Answered by AI
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