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

Shalamar Hospital

Status: Not yet enrolling

Conditions: Preeclampsia (PE)

Treatments: Drug: Aspirin 150 mg; Drug: Aspirin 75 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07041385

IRB - 830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Group A

Experimental group

Description:

Group A: 75 mg aspirin nightly.

Treatment:

Drug: Aspirin 75 mg

Group B

Experimental group

Description:

Group B: 150 mg aspirin nightly.

Treatment:

Drug: Aspirin 150 mg