NCT04070573CompletedPhase 3
Low Doses of Aspirin in the Prevention of Preeclampsia
A Randomized Controlled Trial Comparing Low Doses Of Aspirin In The Prevention Of Preeclampsia (ASAPP)
Source: ClinicalTrials.gov · Last updated 13 Mar 2025
Brief summary (registry, in English)
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 preeclampsia in high-risk women to be recognized by the US Preventive Task Force and should be initiated early in the second trimester of pregnancy, before 16 weeks of gestation. However, currently there is no literature comparing various low-dose ASA formulations in the risk reduction of PE. In the United States, the currently available low-dose ASA is over the counter and is found in 81mg tablets. Therefore, when clinicians initiate therapy with low dose ASA, they may prescribe 1 or 2 tablets of 81mg aspirin per day depending on personal preference and cannot be assisted by evidence to guide their decision.This study aims to determine the incidence of preterm PE or PE with severe features in women taking either 81mg or 162mg in a randomized setting, from a single center. The investigators hypothesize that the information gained from this trial will permit a more accurate sample size calculation for a larger clinical trial powered to accept or reject our testing hypothesis. If our hypothesis is rejected and 162mg of daily ASA is not associated with a lower incidence of severe or preterm PE compared to 81mg, this may be due to lack of power to detect a smaller effect. The investigators would then evaluate the feasibility and results and determine whether a larger trial is reasonable.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (actual)
- First submitted
- 23 Aug 2019
- Start date
- 21 Oct 2019
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Weill Medical College of Cornell University
- NCT number
- NCT04070573
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 400
- From 21 Oct 2019 to the primary completion date, 4 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contraindication to ASA therapy (including but not limited to allergy and high bleeding risk)
Other
- Patient with known intention to terminate pregnancy
- Major fetal malformation seen on ultrasound
Who the study is looking for
- 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)
Criteria the registry did not label
- Patients are currently only being enrolled at the New York Presbyterian Weill Cornell Medicine and at the New York Presbyterian Queens campuses.
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York Presbyterian Queens Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York Presbyterian/Weill Cornell Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.