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

Sponsor
University of Health Sciences Lahore
Study ID
NCT07745595
Status
Not Yet Recruiting

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Conditions

  • Premature Birth
  • Preterm Labor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose Aspirin — DRUG
    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).
  • Placebo — OTHER
    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).

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Feb 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group-I: Aspirin Group
    Participants receive low-dose aspirin (75 mg once daily orally) starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (progesterone and cervical cerclage if indicated)
  • Placebo Comparator: Group-II: Placebo Group
    Participants receive a daily matching oral placebo starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (per-rectal progesterone and cervical cerclage if needed)

Primary Outcome Measure

Incidence of Recurrent Spontaneous Preterm Labor [ Time Frame: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation) ]

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