ISRCTN81414657已完成3 期
ow-dose aspirin in the prevention of preeclampsia: a randomised control study
Beacon Pharmaceuticals Ltd0 个研究点目标入组 200 人开始时间: 2022年5月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 26/05/2022:
- •1. Maternal age =18 years
- •2. Live foetus at gestational age 12–19 weeks
- •3. Any one of the following criteria:
- •3.1. BMI =30 kg/m2
- •3.2. Pregnancy interval >10 years
- •3.3. Multiple pregnancy
- •3.4. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization
- •3.5. Pregnant women with medical disorders, e.g. chronic hypertension, hyperglycaemia in pregnancy, autoimmune disease (e.g. antiphospholipid syndrome [APS], systemic lupus erythematosus [SLE])
- •3.6. Previous history of gestational hypertension, pre-eclampsia or eclampsia
- •3.7. Previous history of intrauterine growth restriction (IUGR), intrauterine death or stillbirth
- •3.8. Family history (mother and/or sister) of hypertension, gestational hypertension or pre-eclampsia
- •Previous inclusion criteria:
- •1. Nulliparous
- •2. Maternal age =16 years and =35 years
- •3. BMI =30 kg/m²
- •4. Live foetus at gestational age 12 weeks – 19 weeks
- •5. Pregnancy interval >10 years
- •6. Multiple pregnancy
- •7. Pregnancy assisted by ovulation-inducing drugs/in vitro fertilization
- •8. Pregnant women with medical disorders: chronic HTN, hyperglycaemia in pregnancy, thyroid disorder, autoimmune disease - antiphospholipid syndrome (APS), systemic lupus erythematosus (SLE)
- •9. Previous history of gestational HTN, preeclampsia (PE), eclampsia
- •10. Previous history of intrauterine growth restriction (IUGR), IUD, stillbirth
- •11. Family history of HTN, gestational HTN, PE (mother and/or sister)
排除标准
- •Current exclusion criteria as of 26/05/2022:
- •1. Allergic to aspirin
- •2. Peptic ulcer disease
- •3. Mental disease
- •4. Treatment with antifolate drugs (antiepileptics, methotrexate)
- •5. Patient will not give consent to participate
- •Previous exclusion criteria:
- •1. Allergic to aspirin
- •2. Peptic ulcer disease
- •3. Pregnant women who are at risk of developing PE but who have renal failure, hepatic failure, cardiac failure and hematological disorder
- •4. Mental disease
- •5. Treatment with antifolate drugs (antiepileptics, methotrexate)
- •6. Patient will not give consent to participate
研究者
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