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

Comparison of Low Dose Aspirin vs Placebo in the Prevention of Recurrent Spontaneous Preterm Labou

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07745595

Enrollment

162

Registered

2026-08-04

Start date

2026-08-20

Completion date

2027-08-15

Last updated

2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, Preterm Labor

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.

Interventions

DRUGLow-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).

OTHERPlacebo

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants are blinded to the treatment modality allotted to them using identical treatment and placebo preparations.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Recurrent Spontaneous Preterm Labor	From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)	Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026