Using hydroxychloroquine to improve pregnancy outcomes in women with antiphospholipid syndrome
Evaluation of the Benefit of Adjuvant Treatment With Hydroxychloroquine to the Usual Medical Management for Obtaining an Uncomplicated Term Pregnancy in Primary Obstetric Antiphospholipid Syndrome
This study is testing if adding hydroxychloroquine to standard treatment can help pregnant women with antiphospholipid syndrome have healthier pregnancies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04275778 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of hydroxychloroquine combined with standard treatment (aspirin and low-molecular-weight heparin) in pregnant women diagnosed with antiphospholipid syndrome (APS). Patients will be randomly assigned to receive either the hydroxychloroquine treatment or a placebo, starting before the 14th week of gestation. Throughout the pregnancy, participants will be monitored monthly for clinical outcomes and biological markers. The goal is to assess whether hydroxychloroquine can reduce complications associated with APS during pregnancy.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old who are currently pregnant and have a history of complications related to antiphospholipid syndrome.
Not a fit: Patients with early isolated miscarriages, contraindications to hydroxychloroquine, or associated systemic lupus may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pregnancy outcomes for women with antiphospholipid syndrome.
How similar studies have performed: While there have been studies on APS treatments, the specific combination of hydroxychloroquine with standard care in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Spontaneous consecutive pregnancy ongoing before the 14th week of gestation -- SAPL obstetrics (modified Sapporo criteria = Sydney criteria) with fetal death ≥10 weeks of gestation without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity \<34SA with placental insufficiency (with or without thrombotic SAPL) * Signed informed consent Exclusion Criteria: * Other SAPL subgroups: early isolated miscarriages \<10 weeks * Contraindication to hydroxychloroquine: * retinopathy, * hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose * Associated systemic lupus, associated Sjogren syndrome * Treatment with hydroxychloroquine in progress * Patient under guardianship or curatorship * Patient deprived of liberty * Lack of Social Insurance
Where this trial is running
Paris
- Hopital Saint Antoine — Paris, France (Recruiting)
Study contacts
- Principal investigator: Arsène MEKINIAN, MD — Internal Medecine_Hospital Saint Antoine
- Study coordinator: Olivier FAIN, MD-PhD
- Email: olivier.fain@aphp.fr
- Phone: 01 49 28 21 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.