Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage. (NCT03358940) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.
210 participantsStarted 2016-03-29
Plain-language summary
Non-medical used of misoprostol for abortion is a growing concern in Guadeloupe. Such situation is reasonable for countries in which abortion is not easy to obtain or prohibited. However regarding the risk of complications, it is less understandable in region like Guadeloupe where legal abortion with medical assistance is accessible for all and free.
The aim of the study is to investigate on the amount of misoprostol taken by women in Guadeloupe, by doing an analytical measurement. The aim is to evaluate batter this practice in Guadeloupe, when the main objective of the study is to detect the presence or the absence of misoprostol in the urine sample of the woman coming at hospital for threatened miscarriage or miscarriage complications. Moreover, these abortions can be more important than spontaneous miscarriage.
Who can participate
Age range
12 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:
* inclusion criteria:
* All patients who come at the maternity emergency unit for miscarriage or threatened miscarriage by 24 weeks of amenorrhea or patient receiving misoprostol for voluntary abortion.
* Age ≥ 12 years old
* Patient insured under the French social security system
Exclusion Criteria:
* Refusal to participate in the study
* Age \< 12 years old
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.
1This study was about detecting misoprostol in urine samples from people with a threatened miscarriage — can you explain what that means for how the drug was being used, and whether that's relevant to my situation?
2Since this trial is listed as 'Phase NA' and focused on detection rather than treatment outcomes, does that mean it wasn't testing whether misoprostol works, but rather how it's being used outside of medical supervision — and what should I know about the safety risks of unsupervised misoprostol use?
3Now that this study is completed, have the findings changed how your practice approaches monitoring or counseling patients with a threatened miscarriage who may have already taken something before coming in?
4If misoprostol use was detected in patients who hadn't been prescribed it, what does that tell us about how people are managing miscarriage symptoms on their own, and is there anything I should be aware of if I'm considering or already using any medications not prescribed by you?
5What are the standard, medically supervised options available to me right now for a threatened miscarriage, and how do they compare in terms of safety to using something like misoprostol without a prescription?
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
1
Detection of misoprostol in urine sample
Timeframe: Enrollment visit
Trial details
NCT IDNCT03358940
SponsorCentre Hospitalier Universitaire de la Guadeloupe