Comparing Two Medical Treatments for Early Pregnancy Failure. (NCT03212352) | Clinical Trial Compass
TerminatedPhase 4
Comparing Two Medical Treatments for Early Pregnancy Failure.
Stopped: Advised by DSMB based on interim-analysis, highly significant difference.
Netherlands342 participantsStarted 2018-06-27
Plain-language summary
This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.
It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.
Who can participate
Age range
16 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:
Early pregnancy failure, 6-14 weeks postmenstrual with
* a crown-rump length ≥ 6mm and no cardiac activity OR
* a crown-rump length \<6mm and no fetal growth at least one week later OR
* a gestational sac with absent embryonic pole for at least one week.
* At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age
* Intra-uterine pregnancy
* Women aged above 16 years
* Hemodynamic stable patient
* No signs of infection
* No signs of incomplete abortion
* No contraindications for mifepristone or misoprostol
Exclusion Criteria:
* Patient does not meet inclusion criteria, discovered after randomization
* Inability to give informed consent
* Known clotting disorder or use of anticoagulants
* Known risk factors for, or presence of, a cardiovascular disease
* Language barrier
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.