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Effective dose of aspirin for prevention of a type of hypertension in pregnancy

Efficacy of aspirin 75 mg vs 150 mg for prevention of preeclampsia in Indian population - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082725
Enrollment
2000
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: O099- Supervision of high risk pregnancy, unspecified

Interventions

Intervention1: Tablet Aspirin 150 mg : Women with risk of preeclampsia of 1: 150 or more will be randomized to receive aspirin orally in two different doses (75 mg and 150 mg) by using computer-genera

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All antenatal patients less than 14 weeks period of gestation attending antenatal out-patient department, PGIMER

Exclusion criteria

Exclusion criteria: Allergic to aspirin, Aspirin contraindicated for medical reasons, refusal of consent, significant malformation, presence of aneuploidy, low platelet count, patient on anticoagulation, patient already on aspirin

Design outcomes

Primary

MeasureTime frame
1. To study the efficacy and safety of 75 mg vs 150 mg aspirin for prevention of preeclampsia in Indian women 2. Incidence of preterm and term pre-eclampsia in both groups 3. Side effects related to aspirin 4. Perinatal morbidity and mortality 5. Possible hurdles for screening for pre-eclampsia Timepoint: 3 years

Secondary

MeasureTime frame
1. Most cost- effective combination of screening strategy in Indian scenario 2. Maternal outcomes in terms of mode & gestation at delivery, development of HELLP, eclampsia, acute kidney injury, postpartum eclampsia, antepartum (abruption) & postpartum hemorrhage 3. Gestation at delivery, mode of delivery 4. Perinatal outcome- Development of IUGR, stillbirth, fetal distress, APGAR score, duration of NICU stay, neonatal death, hemorrhagic disease of newborn, respiratory distress in newborn Timepoint: 3 years

Countries

India

Contacts

Public ContactSnigdha Kumari

Post Graduate Institute of Medical Education and Research

snigdha.obs@gmail.com9831376252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026