NCT07852585

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

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 25, 2026

Last Update Submit

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

EXPERIMENTAL

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.

Drug: Low-dose aspirinOther: No-Aspirin

No-Aspirin-Group

EXPERIMENTAL

Participants received standard antenatal care without aspirin.

Other: No-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.

Aspirin-Group

Participants received standard antenatal care without aspirin.

Aspirin-GroupNo-Aspirin-Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

AspirinN-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Shamsun Nisa, FCPS

    Bahawal Victoria Hospital/Quaid-e-Azam Medical College Bahawalpur

    PRINCIPAL INVESTIGATOR

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.

Locations