Using Warfarin in Pregnant Women with Antiphospholipid Syndrome After the First Trimester
Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
This study tests if switching from a common blood thinner to Warfarin after the first trimester can help pregnant women with antiphospholipid syndrome have better pregnancy outcomes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 38 Years |
| Sex | Female |
| Sponsor | Mansoura University Academic / other |
| Locations | 2 sites (Mansourah, Dakahlia and 1 other locations) |
| Trial ID | NCT02303171 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of switching from low molecular weight heparin (LMWH) to the oral anticoagulant Warfarin after the first trimester in pregnant women diagnosed with antiphospholipid syndrome (APS). Participants will be randomly assigned to receive either LMWH throughout their pregnancy or LMWH in the first trimester followed by Warfarin until delivery. The aim is to determine if this approach can improve pregnancy outcomes for women with APS who are at risk of recurrent miscarriage.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with antiphospholipid syndrome who meet specific weight criteria.
Not a fit: Patients with systemic lupus erythematosus or those with a history of thromboembolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation strategy for pregnant women with APS, potentially reducing the risk of miscarriage.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia * Early pregnancy body weight is 50-90 Kg Exclusion Criteria: * Women with systemic lupus erythematosus (SLE) * Women with active thromboembolic disorders * Women with history of previous thromboembolic disorders
Where this trial is running
Mansourah, Dakahlia and 1 other locations
- Obstetrics and Gynecology Department in Mansoura University Hospital — Mansourah, Dakahlia, Egypt (Recruiting)
- Private practice settings — Mansourah, Dakahlia, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed I Eid, Dr — Mansoura University
- Study coordinator: Mohamed I Eid, Dr
- Email: dr_moh_eid@yahoo.com
- Phone: +201225401274
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.