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NCT04070573 · ClinicalTrials.gov registry record · Phase 3
Low Doses of Aspirin in the Prevention of Preeclampsia
A Phase 3 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
NCT04070573 is a Phase 3 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 400 participants.
The verdict
NCT04070573, a Phase 3 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG acetylsalicylic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2025-01-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04070573
The ClinicalTrials.gov registry entry for NCT04070573 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which acetylsalicylic acid is the first listed.
NCT04070573 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04070573 about?
NCT04070573 is a clinical study titled "Low Doses of Aspirin in the Prevention of Preeclampsia". 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...
What is the current status of trial NCT04070573?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2019-10-21. Estimated completion is 2025-01-23.
What interventions are being tested in trial NCT04070573?
The interventions under investigation include: acetylsalicylic acid (DRUG).
Who is sponsoring clinical trial NCT04070573?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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