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

NCT07745595 | Not Yet Recruiting

• 1 other identifier: Exp143
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief 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

Preterm Labor; Premature Birth

Outcome Measures

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.

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

Study Arms (2)

Group-I: Aspirin Group

EXPERIMENTAL

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)

Drug: Low-dose Aspirin

Group-II: Placebo Group

PLACEBO COMPARATOR

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)

Other: Placebo

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).

Group-I: Aspirin Group

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).

Group-II: Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 years.
• Singleton alive pregnancy.
• History of spontaneous preterm birth (22 to 37 weeks of gestation).
• Hemoglobin (Hb) \> 10 g/dL.
• Absence of fetal anomalies on ultrasound examination.

You may not qualify if:

• Primigravida.
• Multiple pregnancy.
• Maternal age \> 40 years.
• Known history of allergy or hypersensitivity to aspirin.
• Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy.
• Presence of a cervical cerclage prior to study enrollment.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to the treatment modality allotted to them using identical treatment and placebo preparations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share