TerminatedPhase 4

Non-surgical Alternatives to Treatment of Failed Medical Abortion

Stopped: Funding mechanism compromised

United States16 participantsStarted 2016-06-01

Plain-language summary

The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.

Who can participate

Age range

18 Years

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: * Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) \<= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy * Agree to comply with study procedures * Able to consent to study participation Exclusion Criteria: * Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site * Are \< 18 years old in US and Canadian sites * Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac * Are unable to provide contact information for follow-up purposes

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

The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.

Timeframe: One week after taking first study medication

Trial details

NCT IDNCT02704481

SponsorGynuity Health Projects

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-16

View on ClinicalTrials.gov More Abortion Failure trials