ACTRN12618000690257撤回3 期
A Prospective PreecLampsia/Eclampsia Prevention Intervention (APPLE PIE): A randomised controlled trial determining the effect of esomeprazole on the incidence of preeclampsia in a cohort of nulliparous, high BMI women.
niversity of Melbourne (through its Department of Obstetrics and Gynaecology)0 个研究点目标入组 5,500 人开始时间: 2018年4月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Nulliparous
- •BMI of =>30 kg/m² at hospital booking visit
- •12 - 20 weeks of pregnancy at the time of recruitment
- •Singleton pregnancy
- •Age 18 and above
- •Able to comprehend study information
排除标准
- •Patient is unable or unwilling to give consent
- •Known/suspected major fetal malformation or infection
- •Any current use of a PPI
- •Contraindications to the use of esomeprazole
- •Pre-existing renal impairment
- •Pre-existing hepatic impairment
- •HIV, Hepatitis B, or Hepatitis C positive
研究者
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