Randomized Controlled Study to Compare Efficacy of Aspirin 75mg and 150mg In the Prevention of Preeclampsia In High Risk Pregnant Women

NCT07373756 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 599/2025
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preeclampsia in pregnancy is a dreaded complication which has both fetal and maternal adverse outcomes. Studies and WHO have advocated that this complication can be prevented by Aspirin. However which dose is more effective in preventing preeclampsia, whether 75mg or 150mg, will be known from this study.

Conditions

Pregnancy Induced Hypertension (PIH)

Keywords

hypertension, preeclampsia, aspirin

Outcome Measures

Primary Outcomes (1)

• Incidence of Preeclampsia

  Preeclampsia will be assessed during routine antenatal visits and at delivery by trained obstetric clinicians. Blood pressure will be measured using a calibrated sphygmomanometer with the participant in a seated position after adequate rest. Hypertension will be defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg recorded on two occasions at least 4 hours apart after 20 weeks of gestation. Proteinuria will be assessed using urine dipstick testing (≥1+) or 24-hour urine protein estimation (≥300 mg). In the absence of proteinuria, preeclampsia will be diagnosed based on hypertension with evidence of maternal end-organ dysfunction. The incidence of preeclampsia will be recorded after the the time of randomization until delivery .

  1 year (After the time of randomization till delivery)

Study Arms (2)

75mg Aspirin Arm

EXPERIMENTAL

Interventional

Drug: Aspirin

150mg Aspirin Arm

ACTIVE COMPARATOR

Interventional

Drug: Aspirin

Interventions

Aspirin DRUG

This interventional study is being doe in pregnant women after calculationg their Gestosis score and if Gestosis score of 3 or more, they will be randomised into aspirin 75mg and aspirin 150mg in the ratio 1:1. After their delivery, the result will be recorded as to whether preeclampsia had been prevented.

150mg Aspirin Arm; 75mg Aspirin Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All pregnant women with Gestosis score of 3 or more who consents for the study and aged 18 years and above.

You may not qualify if:

• Known hypersensitivity to aspirin, uncontrolled asthma with NSAID sensitivity
• Bleeding disorders, platelet dysfunction, thrombocytopenia, anticoagulant use, active peptic ulcer, history of GI bleed, severe hepatic/ renal disease

Sponsors & Collaborators

• Dr. Sunita Pun: lead

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 28, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01