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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •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%.
排除标准
- •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.
结局指标
主要结局
Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia.
时间窗: After 20 weeks of gestational age
次要结局
- 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)
研究者
Picklu Chaudhuri
Rampurhat Government Medical College