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

N/ANot Yet RecruitingNCT07745595

University of Health Sciences Lahore162 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

162

Conditions

Preterm Labor Premature Birth

Low-dose AspirinDRUG

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).

PlaceboOTHER

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).

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 18 years. 2. Singleton alive pregnancy. 3. History of spontaneous preterm birth (22 to 37 weeks of gestation). 4. Hemoglobin (Hb) \> 10 g/dL. 5. Absence of fetal anomalies on ultrasound examination. Exclusion Criteria: 1. Primigravida. 2. Multiple pregnancy. 3. Maternal age \> 40 years. 4. Known history of allergy or hypersensitivity to aspirin. 5. Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy. 6. Presence of a cervical cerclage prior to study enrollment.

Outcomes

Primary Outcomes

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)