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

NCT07779057 — Phase 4, Recruiting, 60 participants, Medicare Hospital (Pvt) Limited

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

Registry	NCT07779057
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	60 (Estimated)
Sponsor	Medicare Hospital (Pvt) Limited (Other)
Conditions	Preeclampsia
Interventions	Aspirin (Drug)
Dates	start 2026-05-12, primary completion 2026-11-11 (estimated), completion 2026-11-11 (estimated), first posted 2026-08-21, last updated 2026-08-21
Locations	1 site in Pakistan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Low-dose Aspirin	Active comparator	Drug: Aspirin	Participants will be given low-dose aspirin
High-dose Aspirin	Experimental	Drug: Aspirin	Participants will be given high-dose aspirin

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

+Outcome measures

Primary outcomes

Incidence of Preeclampsia [From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation]: Proportion of participants who develop preeclampsia after 20 weeks of pregnancy and before delivery. Preeclampsia will be diagnosed if the patient has proteins excreted in urine (24-hour urine protein >300 mg or urinary protein to creatinine ratio ≥ 0.3 or dipstick 2+) and persistent high blood pressure ≥ 140/90 mmHg for minimum of 4 hours or ≥160/110 mmHg),

Secondary outcomes

Stillbirth [From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation]: Proportion of pregnancies resulting in stillbirth. Stillbirth will be defined as delivery of baby with no signs of life.

Other outcomes

Neonatal Birth Weight [From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation]: Birth weight of the newborn measured in grams using a digital weighing scale within 3 hours of birth.

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* Gestational age 11-14 weeks
* High risk of preeclampsia

Exclusion Criteria:

* Active gastritis
* Abnormal coagulation profile (INR > 1.5)
* Renal disease
* Platelet count < 150,000/mm\^3
* Fetal malformations
* Vaginal bleeding

+Locations (1)

Facility	City	Country	Status
Medicare Hospital (Pvt) Ltd.	Multan, Punjab Province	Pakistan	Recruiting

+Investigators

Samee A Professor, FRCOG, Study chair, Medicare Hospital (Pvt) Ltd.