Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07041385

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shalamar Hospital

Lahore, Punjab Province, 54000, Pakistan

Location contact

Dr. Hafiz Wajahat Naseem Naseem, M.B.B.S

CONTACT

[email protected]

+923237435943

Dr. Hafiz Wajahat Naseem Naseem, M.B.B.S

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Aspirin 75 mg

Drug

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.

Aspirin 150 mg

Drug

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.

Primary outcomes

  1. Pre - eclampsia

    Time frame: 9 months

    PE (Pre-eclampsia) Yes / No Early Onset - Pre-eclampsia (<34 weeks) Yes / No Late Onset - Pre-eclampsia (>34 weeks) Yes / No

Secondary outcomes

  1. Delivery

    Time frame: 9 months

    Preterm - Pre-eclampsia Delivery (<37 weeks) Yes / No Term Delivery - Pre-eclampsia (>37 weeks) Yes / No

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Hafiz Wajahat Naseem Naseem, M.B.B.S

CONTACT

[email protected]

+923237435943

Sponsors and collaborators

Lead sponsor

Shalamar Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.