Discontinuing aspirin early in high-risk pregnant women to prevent preeclampsia
Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial
This study is testing if stopping low-dose aspirin early in high-risk pregnant women can prevent preeclampsia just as well as continuing it longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06111079 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal timing for discontinuing low-dose aspirin in pregnant women at high risk for preeclampsia. It compares the effects of stopping aspirin at 28 weeks of gestation versus continuing until 36 weeks. Participants will be monitored for their mean arterial pressure and placental growth factor levels, and the incidence of preterm preeclampsia will be assessed. The goal is to determine if early discontinuation is as effective as the standard approach, potentially reducing risks and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 16 weeks of gestation with a normal NT scan and at least one high-risk factor or two moderate-risk factors.
Not a fit: Patients who started aspirin after 16 weeks of gestation or those with aspirin intolerance or allergy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the incidence of preterm preeclampsia and associated complications in high-risk pregnant women.
How similar studies have performed: While there is limited direct evidence on the timing of aspirin discontinuation, this study aims to fill a gap in existing guidelines, suggesting a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. At \<16 weeks of gestation, normal NT scan 2. At least 1 high risk factor or at least 2 moderate risk factors 3. Intend to receive prenatal examination and deliver in this institution 4. Signed a written informed consent for participation in the study Exclusion Criteria: 1. Aspirin initiated after 16 week 2. Intolerant or allergic to aspirin 3. Aspirin adherence was \<80% 4. Miscarriage or termination of pregnancy before randomization 5. drop out (do not return to the hospital for delivery). 6. Lost to follow-up
Where this trial is running
Guangzhou, Guangdong
- Fang He — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Fang He, M.D — The Third Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Fang He, M.D
- Email: hefangjnu@126.com
- Phone: +86 13724831279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.