Comparing the Efficacy of 75mg Versus 150mg Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women

Not Applicable

Not yet recruiting

• Conditions: Preeclampsia (PE)
• Interventions: Drug: Aspirin 75 mg; Drug: Aspirin 150 mg

• Registration Number: NCT07041385
• Lead Sponsor: Shalamar Hospital

Brief Summary

This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Existing literature suggests that the 150 mg aspirin dose may exhibit superior efficacy, yet inconclusive evidence exists in our local setting.

Detailed Description

Pre-eclampsia is a major factor in both maternal and fetal morbidity and mortality. The most widely investigated preeclampsia prevention medication is low dose Aspirin. However, guidelines differ considerably regarding the prophylactic dose of Aspirin for preeclampsia. Pre-eclampsia (PE) affects 5-7% of all pregnancies and along with eclampsia is the major contributor to maternal morbidity and 10-15% of maternal mortality and also perinatal mortality. Low dose aspirin administration can reduce vasoconstriction and decreases thrombosis of the vessels related to placenta, thereby increases blood flow and protects against to pregnancy related complication like preeclampsia, IUGR or FGR. One of the major therapeutic interventions to prevent preeclampsia is the use of Aspirin (a COX-II inhibitor with anti-inflammatory and anti-thrombotic properties). Initiating low-dose aspirin (LDA) therapy in early pregnancy from 12 weeks can prevent the onset of pre-eclampsia or delay it. The antiplatelet and vasodilatory effect of aspirin induced by the inhibition of cyclooxygenase-1 (COX-1) and reduced production of thromboxane, a potent vasoconstrictor and platelet aggregator, enhances placental blood circulation. Moreover, potential anti-inflammatory properties can improve endothelial dysfunction and oxidative stress, which are the central pieces of preeclampsia mechanisms.

The dose of aspirin used in most hospital settings is low dose, which has its benefits outweigh the risks and side effects of the drug. Many studies evaluated low doses of Aspirin 60-80mg showing a 10%-50% reduction in the incidence of preeclampsia, while a few studies also evaluated the efficacy of a 150mg dose. To our knowledge, this is among very few studies to investigate the effectiveness of relatively higher doses of aspirin in the Pakistani population.

Study Timeline

• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-27
• Status Verified: 2025-09
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-08
• Study Start: 2025-11-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

1. Screen positive women
2. Age 18 - 30 y
3. Gestational Age 11 - 13+6 weeks
4. Singleton Pregnancy
5. Estimated risk for preterm PE of > 1 in 100 (Reference - Fetal Medicine Foundation)

Exclusion Criteria

1. Screen negative women
2. Age > 30 y
3. Gestational Age > 14 weeks
4. Multiple Gestation
5. Estimated risk for preterm PE of < 1 in 100 (Reference - Fetal Medicine Foundation)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Aspirin 75 mg	Group A: 75 mg aspirin nightly.
Group B	Aspirin 150 mg	Group B: 150 mg aspirin nightly.

Primary Outcome Measures

Name	Time	Method
Pre - eclampsia	9 months	PE (Pre-eclampsia) Yes / No Early Onset - Pre-eclampsia (\<34 weeks) Yes / No Late Onset - Pre-eclampsia (\>34 weeks) Yes / No

Secondary Outcome Measures

Name	Time	Method
Delivery	9 months	Preterm - Pre-eclampsia Delivery (\<37 weeks) Yes / No Term Delivery - Pre-eclampsia (\>37 weeks) Yes / No

Trial Locations

Locations (1)

Shalamar Hospital; 🇵🇰 Lahore, Punjab Province, Pakistan