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
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Rampurhat Government Medical College
- Enrollment
- 1,518
- Locations
- 1
- Primary Endpoint
- Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia.
Overview
Brief Summary
We intend to conduct a randomized controlled interventional study among individuals attending a peripherally located government-run tertiary care hospital, to see whether the use of a higher 150 mg dose of aspirin, compared with that of 75 mg aspirin, in women at risk of pre-eclampsia, has greater benefit in terms of certain maternal and perinatal outcomes. The present study primarily aims to compare differences in the efficacy and safety of prophylactic use of 150 mg aspirin in comparison to 75 mg aspirin in women with known risk factors for development of preeclampsia.A two-arm double-blind parallel group randomized control trial will be conducted in the Department of Obstetrics and Gynaecology, Rampurhat Govt Medical College, Birbhum. Pregnant women between 12 and 14 weeks of gestational age attending the antenatal clinic and meeting the inclusion criteria will be enrolled in the study after obtaining a written informed consent. The study will be carried out over a period of 1.5 years with a target sample size of 1518 . Exclusion criteria include active peptic ulcer disease, bleeding disorder, thrombocytopenia , history of vaginal bleeding and fetus diagnosed with malformations or aneuploidy during ultrasound screening, known allergy to aspirin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Previous history of preeclampsia 2.chronic hypertension, 3.chronic renal disease,
- •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
- •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.
Outcomes
Primary Outcomes
Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia.
Time Frame: After 20 weeks of gestational age
Secondary Outcomes
- 1.To study and compare the serious adverse maternal and fetal outcomes in the two treatment groups.
- 2.To study the nature of and to compare the frequency of drug related adverse events in the two treatment groups.(After 20 weeks of gestational age)
Investigators
Picklu Chaudhuri
Rampurhat Government Medical College