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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07041385
Enrollment
340
Registered
2025-06-27
Start date
2025-11-01
Completion date
2027-06-30
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia (PE)

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.

Interventions

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. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly.

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. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly.

Sponsors

Shalamar Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pre - eclampsia9 monthsPE (Pre-eclampsia) Yes / No Early Onset - Pre-eclampsia (\<34 weeks) Yes / No Late Onset - Pre-eclampsia (\>34 weeks) Yes / No

Secondary

MeasureTime frameDescription
Delivery9 monthsPreterm - Pre-eclampsia Delivery (\<37 weeks) Yes / No Term Delivery - Pre-eclampsia (\>37 weeks) Yes / No

Countries

Pakistan

Contacts

Primary ContactDr. Hafiz Wajahat Naseem Naseem, M.B.B.S
wnaseem60@gmail.com+923237435943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026