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

NCT07779057 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-21

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Medicare Hospital (Pvt) Limited

    lead OTHER

Principal Investigators

  • Samee A Professor, FRCOG · Medicare Hospital (Pvt) Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2026-11-11
Completion
2026-11-11

Countries

  • Pakistan

Study Locations

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Entities

Drugs
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 NCT07779057 on ClinicalTrials.gov