Status:
COMPLETED
Low Doses of Aspirin in the Prevention of Preeclampsia
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Preeclampsia
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
Preeclampsia (PE) is a morbid and potentially lethal complication of pregnancy and is more common in women with specific risk factors. Aspirin (ASA) is currently the only prophylactic therapy for pree...
Detailed Description
Preeclampsia (PE) is a serious and potentially fatal complication of pregnancy. It is a placental disease characterized by an elevated blood pressure in the 3rd trimester with multisystem involvement ...
Eligibility Criteria
Inclusion
- Patients are currently only being enrolled at the New York Presbyterian Weill Cornell Medicine and at the New York Presbyterian Queens campuses.
- Pregnant patients, ≥18 years old, at less than 16 weeks' gestation (as documented by ultrasound) with at least one of the following risk factors for developing PE:
- PE in a prior pregnancy
- Chronic hypertension (prior to pregnancy or before 20 weeks' gestation)
- Type 1 or 2 diabetes
- Renal disease (proteinuria ≥300mg/day or estimated GFR\<90mL/min/1.73 m2)
- Multifetal gestation
- Autoimmune disease (e.g. systemic lupus erythematous, antiphospholipid syndrome)
Exclusion
- Patient with known intention to terminate pregnancy
- Major fetal malformation seen on ultrasound
- Contraindication to ASA therapy (including but not limited to allergy and high bleeding risk)
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04070573
Start Date
October 21 2019
End Date
January 23 2025
Last Update
March 13 2025
Active Locations (2)
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1
New York Presbyterian - Weill Cornell
New York, New York, United States, 10065
2
New York Presbyterian Queens
New York, New York, United States, 11355