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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years.

Singleton alive pregnancy.

History of spontaneous preterm birth (22 to 37 weeks of gestation).

Hemoglobin (Hb) > 10 g/dL.

Disqualifiers

Primigravida.

Multiple pregnancy.

Maternal age > 40 years.

Known history of allergy or hypersensitivity to aspirin.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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).

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Group-I: Aspirin GroupExperimental treatment 1 intervention
Group B: Group-II: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Recurrent Spontaneous Preterm Labor

Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.

Time frame
From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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