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RECRUITING
NCT07779057
PHASE4

Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia

Sponsor: Medicare Hospital (Pvt) Limited

View on ClinicalTrials.gov

Summary

The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is: 1. Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia? 2. Are there differences in stillbirth and newborn birth weight between the two aspirin doses? The study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups. * Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime. * Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime. Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery. The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth. The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.

Official title: High Versus Low Dose Aspirin Effects on Fetomaternal Outcomes in Women With High Risk of Preeclampsia

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05-12

Completion Date

2026-11-11

Last Updated

2026-08-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Aspirin

Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.

DRUG

Aspirin

Aspirin 150 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy

Locations (1)

Medicare Hospital (Pvt) Ltd.

Multan, Punjab Province, Pakistan