CompletedNot Applicable

Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

United States1,001 participantsStarted 2011-08

Plain-language summary

The purpose of this study is to determine the efficacy and acceptability of a regimen of 200 mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women of reproductive age * Gestational age less than or equal to 70 days LMP * Willing and capable of accepting and participating * Eligible for medical abortion according to the clinic's evaluation * Willing to undergo a surgical intervention to complete the abortion if necessary * Willing to provide an address and/or telephone number for follow up * Have easy, straightforward access to a telephone and emergency transport Exclusion Criteria: * Gestational age is greater than 70 days LMP * Suspicion or diagnosis of ectopic pregnancy or undiagnosed adnexal mass * Use of IUD (note: the woman will be eligible when she removes the IUD) * Chronic renal failure * Current long term treatment with corticosteroids * Allergy to mifepristone, misoprostol, or other prostaglandin * Coagulopathies or current treatment with anti-coagulants * Hereditary porphyrias

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy

Timeframe: One week after enrollment

Trial details

NCT IDNCT01966874

SponsorGynuity Health Projects

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-05

View on ClinicalTrials.gov More Medical; Abortion, Fetus trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.