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To study dose of aspirin effective in prevention of hypertensive disorders of pregnancy

Pilot interventional study by different low doses of aspirin versus placebo for prevention of preeclampsia - A Double blind randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011155
Enrollment
150
Registered
2018-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O369- Maternal care for fetal problem, unspecified

Interventions

Intervention1: aspirin 75 mg: using aspirin 75 mg before 14 weeks pregnancy Control Intervention1: aspirin 150 mg: using aspirin 150 mg before 14 weeks Control Intervention2: placebo: inert sucrose

Sponsors

Intramural grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.History : chronic hypertension /past history of severe PE/ past history of Eclampsia/ past history of severe intrauterine growth retardation with normal fetal morphology 2. Mean arterial pressure of more than 90th centile 3.Uterine artery raised pulsatality index of more than 90th centile

Exclusion criteria

Exclusion criteria: Maternal history: 1. Known case of Antiphospholipid antibody syndrome ,Thrombophillia. 2.Maternal medical diseases: peptic ulcer disease, bleeding disorder, chronic kidney disease. Present pregnancy: 1. Maternal thrombocytopenia ( platelet count 2. History of bleeding per vaginum 3. Fetus diagnosed with malformations/ anomaly/ aneuploidy

Design outcomes

Primary

MeasureTime frame
To assess differences in outcome between prophylactic uses of low-dose 150 mg aspirin versus 75 mg aspirin versus placebo. Timepoint: 22 weeks

Secondary

MeasureTime frame
1. To document effect of different doses of aspirin on maternal (Incidence of early PE with delivery 34 weeks, placental abruption, eclampsia) and fetal (intrauterine growth retardation and stillbirth) outcomes 2. To assess the correlation of various predictors(inclusion criteria) of PE with fetomaternal outcomes. Timepoint: 1 year

Countries

India

Contacts

Public ContactNamrata Kumar

Doctor

dr.nmrata@gmail.com9415118848

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026