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Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour

NCT07745595 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-08-12

No results posted yet for this study

Summary

Preterm birth-defined as delivery before 37 weeks of gestation-is a leading cause of neonatal morbidity and mortality worldwide, particularly in resource-limited settings. Women with a history of spontaneous preterm birth face a significantly higher risk of experiencing premature labor in subsequent pregnancies. Impaired uteroplacental blood flow, inflammation, and abnormal clot formation are key contributing factors to spontaneous preterm delivery.

Low-dose aspirin is an affordable, widely available medication that exerts anti-inflammatory and antithrombotic effects by inhibiting platelet aggregation and prostaglandin synthesis. This study aims to evaluate whether low-dose aspirin (75 mg daily), initiated between 8 and 16 weeks of gestation, can effectively reduce the incidence of recurrent spontaneous preterm labor in pregnant women with a prior history of premature delivery compared to a placebo. Participants will be monitored throughout their pregnancy up to 36 weeks or delivery to evaluate gestational age at birth and labor outcomes.

Conditions

Interventions

DRUG

Low-dose Aspirin

Participants take low-dose aspirin 75 mg orally once daily starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery (whichever comes first), alongside routine clinical care (progesterone and cervical cerclage if indicated).

OTHER

Placebo

Participants take a daily matching oral placebo tablet starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery, alongside routine clinical care (per-rectal progesterone and cervical cerclage if indicated).

Sponsors & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-02-15
Completion
2027-08-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745595 on ClinicalTrials.gov