A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Ant… (NCT04624269) | Clinical Trial Compass
UnknownPhase 4
A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome
China384 participantsStarted 2020-12-01
Plain-language summary
The efficacy of low-dose aspirin combined with low-molecular-weight heparin treatment for improving antiphospholipid syndrome and maternal-fetal outcome of patients is recognized by various countries and recommended by the guidelines. However, there are still 20-30% of APS patients whose treatment fails. Therefore, the standard treatment effect is still not ideal, and other treatment options need to be explored. The purpose of this study is to conduct a randomized double-blind, parallel controlled study of patients with recurrent miscarriage and APS in addition to standard treatment, plus hydroxychloroquine sulfate (HCQ) or placebo, to observe the effects of HCQ on pregnancy outcome in patients with abortion and APS, to evaluate the effectiveness and safety of HCQ treatment.
Who can participate
Age range
18 Years – 45 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:
* Patients who want to conceive，with recurrent miscarriage and antiphospholipid syndrome (APS) .
* Agree to join the study and sign the informed consent of the study.
Exclusion Criteria:
* Women who are already pregnant.
* Allergies or adverse events to Hydroxychloroquine(HCQ),such as allergies to the active substance -aminoquinoline or allergies to HCQ or any other chemical components of placebo.
* Patients with any changes in the retina or visual field caused by treatment with 4-aminoquinoline compounds;
* HCQ is currently being used
* Weight \<45kg
* Psoriasis
* Uncontrolled epilepsy
* Anti-ENA antibody positive
* Renal replacement therapy
* Other serious active complications (human immunodeficiency virus, hepatitis B)
* Porphyria
* History of retinopathy
* History of galactose intolerance, history of lactase deficiency, or history of glucose-galactose malabsorption
* Participate in any other clinical trial drug research at the same time.
* Previous treatment failure with Hydroxychloroquin
* Others: such as poor compliance, or those who cannot be followed up on schedule due to certain factors.
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
1
Hydroxychloroquine can improve the pregnancy outcome of patients with recurrent miscarriage and antiphospholipid syndrome
Timeframe: 16 weeks
Trial details
NCT IDNCT04624269
SponsorShanghai First Maternity and Infant Hospital