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NCT03893630 · ClinicalTrials.gov registry record · Phase 2
Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia
A Phase 2 study, sponsored by John O'Brien, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 208
- Enrollment target
NCT03893630 is a Phase 2 study that has completed, run by John O'Brien, MD. The registered enrollment target is 208 participants.
The verdict
NCT03893630, a Phase 2 study, has completed, sponsored by John O'Brien, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 208 participants
- Enrollment target
Study Summary
Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia. Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.
Interventions
- OTHER Control
- DRUG Acetylsalicylic Acid 81 mg
- DRUG Acetylsalicylic Acid 162 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2019-04-25 |
| Est. Completion | 2022-09-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893630
The ClinicalTrials.gov registry entry for NCT03893630 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John O'Brien, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT03893630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03893630 about?
NCT03893630 is a clinical study titled "Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia". Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies...
What is the current status of trial NCT03893630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2019-04-25. Estimated completion is 2022-09-28.
What interventions are being tested in trial NCT03893630?
The interventions under investigation include: Control (OTHER), Acetylsalicylic Acid 81 mg (DRUG), Acetylsalicylic Acid 162 mg (DRUG).
Who is sponsoring clinical trial NCT03893630?
This trial is sponsored by John O'Brien, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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