Comparison of Pregnancy Outcomes in Primigravida Receiving Low-Dose Aspirin for the Prevention of Preeclampsia.
Low-Dose Aspirin: A Game-Changer in Preventing Pre-Eclampsia and Adverse Pregnancy Outcomes in Primigravida
1 other identifier
interventional
160
1 country
1
Brief Summary
Local data on the effectiveness of low-dose aspirin in high-risk primigravida are limited. The present study was planned to compare pregnancy outcomes between high-risk primigravida receiving low-dose aspirin (75 mg/day) from 12 weeks of gestation and those not receiving aspirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
1 active site
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 Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
CompletedFirst Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedOctober 1, 2026
September 1, 2026
11 months
September 25, 2026
September 25, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Preeclampsia
The frequency of patients developing preeclampsia as new-onset hypertension after 20 weeks of gestation was noted.
After 24 weeks of the enrollment
Placental abruption
The frequency of patients with placental abruption.
After 24 weeks of the enrollment
Preterm birth
The frequency of neonates born before 37 completed weeks was noted.
At birth, after 24 weeks of the enrollment
Low-birth-weight
The frequency of low-birth-weight neonates, defined as a birth weight\<2.5 kg, was noted.
At birth, after 24 weeks of the enrollment
Study Arms (2)
Aspirin-Group
EXPERIMENTALParticipants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care.
No-Aspirin-Group
EXPERIMENTALParticipants received standard antenatal care without aspirin.
Interventions
Participants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care.
Participants received standard antenatal care without aspirin.
Eligibility Criteria
You may qualify if:
- Primigravida women
- High-risk pregnancy
- Aged 18-40 years
- Singleton pregnancy
- Gestational age ≤12 weeks
You may not qualify if:
- Women with pre-existing chronic hypertension
- Renal disease
- Diabetes mellitus
- Autoimmune disease
- Bleeding disorders
- Hypersensitivity to aspirin
- History of peptic ulcer disease
- Those using aspirin or other antiplatelet drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shamsun Nisa, FCPS
Bahawal Victoria Hospital/Quaid-e-Azam Medical College Bahawalpur
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Consultant
Study Record Dates
First Submitted
September 25, 2026
First Posted
October 1, 2026
Study Start
August 1, 2025
Primary Completion
June 30, 2026
Study Completion
June 30, 2026
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Data can be shared on a reasonable request.