NCT07087067

Aspirin Role for Preventing Clinical Risks Related to High Risk Pregnancy

Completed NA Last updated 25 July 2025

What this trial tests

NA trial testing Aspirin 75 mg in Preeclampsia in 87 participants. Completed in 12 February 2025.

Timeline

5 February 2023

Primary endpoint
12 February 2025

12 February 2025

Quick facts

Lead sponsor	Galala University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	87
Start date	5 February 2023
Primary completion	12 February 2025
Estimated completion	12 February 2025
Sites	1 location across Egypt

Drugs / interventions tested

• Aspirin 75 mg

Conditions studied

• Preeclampsia — all drugs for Preeclampsia →
• Pregnancy — all drugs for Pregnancy →

Sponsor

Galala University

Who can join

Eligibility, female only, with Preeclampsia or Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early initiation of low-dose aspirin for the prevention of pre-eclampsia in high-risk pregnancies.
   Alsulami FT, Hamed EM. · · 2026 · PMID 41530193 · DOI 10.1038/s41598-025-28078-3