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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: Completed Phase 2 study, sponsored by John O'Brien, MD.
NCT03893630 is a Phase 2 study that has completed, run by John O'Brien, MD. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Uterine artery doppler is used to assess impedance to flow in the uterine artery three times: 11-16 weeks gestation(baseline), 18-22 weeks gestation (event 2), 28-32 weeks gestation (event 3). Data reported as change between 11-16 weeks gestation (baseline) and either 18-22 weeks gestation (event 2) or 28-32 weeks gestation (event 3). difference in uterine artery pulsatility index (PI) is calculated as the difference in PI for each patient between each trimester visit. PI at each visit will be
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 |
What the finished NCT03893630 record still lists
NCT03893630 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).
The record links to 0 conditions, and to 3 interventions - of which Control is the first listed.
NCT03893630 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03893630's enrollment target sits among peer trials
208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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