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Aspirin Role for Preventing Clinical Risks Related to High Risk Pregnancy

NCT07087067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-07-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Aspirin 75 mg

patients received aspirin 75 mg daily prior to 12 weeks gestation

Sponsors & Collaborators

  • Galala University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-05
Primary Completion
2025-02-12
Completion
2025-02-12

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087067 on ClinicalTrials.gov