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Comparison of a smaller and a higher dose of aspirin to stop occurrence of a hypertension-related harmful condition seen in pregnant women having some risk factors

Comparison of Efficacy and Safety of 150 mg versus 75mg of Aspirin in Preven-tion of Preeclampsia in Women at Risk: A Double-Blind Randomized Controlled Trial - Not Applicable

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097380
Enrollment
1518
Registered
2025-11-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: O098- Supervision of other high risk pregnancies

Interventions

Intervention1: 150 mg tablet of aspirin orally daily: Oral administration tablet aspirin 150 mg at bedtime from 12 weeks of gestation till 36 completed weeks (total duration of therapy 24 weeks) Contr

Sponsors

Rampurhat Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Previous history of preeclampsia 2.chronic hypertension, 3.chronic renal disease, 4. known SLE, 5.known Antiphospholipid syndrome, 6.Type 1 or Type 2 Diabetes, 7.pregnancy by ART and the presence of at least two of the factors associated with a moderate risk of developing preeclampsia like primigravida, age 35 years or more, age less than 19 years, pregnancy interval 10 years or more, multiple pregnancy, BMI 35 or more, 8.Known hypothyroid, 9.known PCOS, 10.anemia with Hb% less than 8 gm%

Exclusion criteria

Exclusion criteria: 1.Active peptic ulcer disease 2.Coagulation disorder 3.Thrombocytopenia 4.History of vaginal bleeding and fetus diagnosed with malformations or aneuploidy in transvaginal ultrasound 5.Known allergy to Aspirin.

Design outcomes

Primary

MeasureTime frame
Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia.Timepoint: After 20 weeks of gestational age

Secondary

MeasureTime frame
1.To study and compare the serious adverse maternal and fetal outcomes in the two treatment groups. Timepoint: After 20 weeks of gestational age;2.To study the nature of and to compare the frequency of drug related adverse events in the two treatment groups.Timepoint: After 20 weeks of gestational age

Countries

India

Contacts

Public ContactPicklu Chaudhuri

Rampurhat Government Medical College

picklu.chaudhuri@gmail.com9432277443

Outcome results

None listed

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