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

Sponsor
Medicare Hospital (Pvt) Limited
Study ID
NCT07779057
Phase
PHASE4
Status
Recruiting
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Conditions

  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Aspirin — DRUG
    Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.
  • Aspirin — DRUG
    Aspirin 150 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
May 12, 2026
Status verified
Aug 2026
Primary completion
Nov 11, 2026
Completion
Nov 11, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Low-dose Aspirin
    Participants will be given low-dose aspirin
  • Experimental: High-dose Aspirin
    Participants will be given high-dose aspirin

Primary Outcome Measure

Incidence of Preeclampsia [ Time Frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation ]

Central Contacts

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