IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy (NCT03152058)
Certolizumab to Prevent Pregnancy Complications in High-Risk Patients With APS or SLE - (IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy)
🩺 Plain-English Summary (8th-Grade Level)
This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
Who can join: Review the eligibility criteria below.
Location: Hospital for Special Surgery — New York, New York
Age range: 18 Years to 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Hospital for Special Surgery — New York, New York
- University of Utah — Salt Lake City, Utah
- TRIO Advancing Reproductive Care — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (801) 585-7617
Email: Rose.Peckham@hsc.utah.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in High Risk Pregnancy
- Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies — Montreal, Quebec
- Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise — Madison, Wisconsin
- Remote Fetal Monitoring in High Risk Pregnancies — Boston, Massachusetts
Explore by condition: All High Risk Pregnancy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.