NCT07779057

Brief Summary

The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is:

  • Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime.
  • Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime. Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery. The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth. The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
1mo left

Started May 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
May 2026Nov 2026

Study Start

First participant enrolled

May 12, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2026

Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 18, 2026

Last Update Submit

August 18, 2026

Conditions

Preeclampsia

Keywords

AspirinBirth weightPregnancyPreeclampsiaStillbirth

Outcome Measures

Primary Outcomes (1)

  • Incidence of Preeclampsia

    Proportion of participants who develop preeclampsia after 20 weeks of pregnancy and before delivery. Preeclampsia will be diagnosed if the patient has proteins excreted in urine (24-hour urine protein \>300 mg or urinary protein to creatinine ratio ≥ 0.3 or dipstick 2+) and persistent high blood pressure ≥ 140/90 mmHg for minimum of 4 hours or ≥160/110 mmHg),

    From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation

Secondary Outcomes (1)

  • Stillbirth

    From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation

Other Outcomes (1)

  • Neonatal Birth Weight

    From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation

Study Arms (2)

Low-dose Aspirin

ACTIVE COMPARATOR

Participants will be given low-dose aspirin

Drug: Aspirin

High-dose Aspirin

EXPERIMENTAL

Participants will be given high-dose aspirin

Drug: Aspirin

Interventions

AspirinDRUG

Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.

Low-dose Aspirin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age 11-14 weeks
  • High risk of preeclampsia

You may not qualify if:

  • Active gastritis
  • Abnormal coagulation profile (INR \> 1.5)
  • Renal disease
  • Platelet count \< 150,000/mm\^3
  • Fetal malformations
  • Vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicare Hospital (Pvt) Ltd.

Multan, Punjab Province, 60000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaBirth WeightStillbirth

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFetal DeathDeathPathologic Processes

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Samee A Professor, FRCOG

    Medicare Hospital (Pvt) Ltd.

    STUDY CHAIR

Central Study Contacts

Fiza A Principal Investigator, MBBS

CONTACT

+92 336 6005416fiza.arshad66@gmail.com

Samee A Professor, FRCOG

CONTACT

+92 300 8637070sameeakhtar54@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 21, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

November 11, 2026

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)