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

NCT07041385 | Not Yet Recruiting

• 1 other identifier: IRB - 830
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia (PE)

Outcome Measures

Primary Outcomes (1)

• Pre - eclampsia

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

  9 months

Secondary Outcomes (1)

• Delivery

  9 months

Study Arms (2)

Group A

EXPERIMENTAL

Group A: 75 mg aspirin nightly.

Drug: Aspirin 75 mg

Group B

EXPERIMENTAL

Group B: 150 mg aspirin nightly.

Drug: Aspirin 150 mg

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: All Pregnant Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shalamar Hospital: lead

Study Sites (1)

Shalamar Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

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

CONTACT

+923237435943; wnaseem60@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident in Gynae and OBS. Department

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)