NCT07087067Completed
Aspirin Role for Preventing Clinical Risks Related to High Risk Pregnancy
Early Initiation of Low-Dose Aspirin for the Prevention of Preeclampsia in High-Risk Pregnancies.
Source: ClinicalTrials.gov · Last updated 25 Jul 2025
Brief summary (registry, in English)
Preeclampsia and its related consequences significantly contribute to maternal and neonatal morbidity and mortality, particularly in high-risk pregnancies. Low-dose aspirin has shown promise in reducing these risks, particularly when initiated early in gestation. This study evaluated the effectiveness of 75 mg aspirin, started before 12 weeks of gestation, in reducing adverse pregnancy outcomes among high-risk pregnant women. A randomized controlled trial was undertaken with high-risk pregnant women. Pregnant women were randomized in a 1:1 ratio to receive 75 mg of aspirin or a control daily from enrollment (\<12 weeks of gestation) until 36 weeks of delivery. High-risk status was defined by established clinical criteria. The incidence of preeclampsia was the primary outcome. The researchers considered preterm birth, fetal growth restriction (FGR), perinatal mortality, neonatal intensive care unit (NICU) admission, gestational hypertension, neonatal morbidity, and postpartum hemorrhage as secondary outcomes. The outcomes were compared using Fisher's exact test, chi-square, and two-sample z-tests. Initiation of 75 mg of low-dose aspirin early in high-risk pregnancies significantly reduced preeclampsia and several adverse neonatal outcomes without increasing maternal risk. These findings support the early start of low-dose aspirin as a safe and effective strategy for preeclampsia prevention in high-risk women.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 9 Jun 2025
- Start date
- 5 Feb 2023
- Primary completion date
- 12 Feb 2025
- Lead sponsor
- Galala University
- NCT number
- NCT07087067
What you commit to
- Study type: Interventional
- Participants enrolled: 87
- From 5 Feb 2023 to the primary completion date, 12 Feb 2025
- 1 site 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.
Prior treatment
- Current or prior use of aspirin or other antiplatelet/anticoagulant therapy during the current pregnancy.
Other illness
- Known hypersensitivity to aspirin.
- Peptic ulcer history, gastrointestinal bleeding, or coagulopathy.
Lab values
- A platelet count of less than 100,000/μL or the presence of known bleeding disorders is a concern.
Other
- Severe hepatic or renal dysfunction (CKD stage IV or above).
- Known major fetal anomaly or chromosomal abnormality.
- Engaging in a different clinical trial could potentially impact the results.
Who the study is looking for
- Pregnant women were considered according to the subsequent criteria:
- Age ≥18 years.
- These criteria applied to both singleton and multifetal pregnant women.
- The gestational age was less than 12 weeks at the time of randomization, confirmed by a first-trimester ultrasound.
- Each participant must possess at least one of the major risk factors mentioned above.
- Being willing and able to give informed consent and follow trial processes. Exclusion Criteria
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eman Hamed Coordinator of this site? Confirm its status | Suez | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.