ISRCTN45790835已完成不适用
A pilot study to evaluate glyceryl trinitrate (GTN) as a novel therapeutic for the prevention and treatment of pre-eclampsia
Queen's University (Canada)0 个研究点目标入组 80 人开始时间: 2007年12月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
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
- •Women of childbearing years (approximately 18 - 42 years).
- •Prevention arm:
- •All women with a past obstetrical history of one or more cases of severe early onset pre-eclampsia or later onset severe pre-eclampsia associated with haemolysis, elevated liver enzymes, low blood levels of platelets (HELLP) syndrome.
- •Treatment arm:
- •All women that have been diagnosed with pre-eclampsia that are being followed clinically and that provide informed consent. For a diagnosis of pre-eclampsia a patient must meet all three criteria:
- •1. Systolic blood pressure greater than 140 mmHg or an increase of 30 mmHg from the participant?s baseline (with that increase present at two measurements taken 6 hours apart)
- •2. Diastolic blood pressure greater than 90 mmHg or an increase of 15 mmHg from the participant?s baseline (with that increase present at two measurements taken 6 hours apart)
- •3. Proteinuria greater than 0.3 g in 24 hour urine or 2+ on dipstick
排除标准
- •Potential women excluded are those:
- •1. That have a contraindication to use of isosorbide mononitrate (ISMN)
- •2. That have either a maternal or foetal indication for delivery
- •3. That have a diagnosis of severe pre-eclampsia (diastolic blood pressure greater than 100 mmHg; proteinuria greater than 1 g/d), eclampsia, or HELLP syndrome at time of recruitment
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