EUCTR2020-003410-12-GB进行中（未招募）1 期
Pregnancy ANtihypertensive Drugs: which Agent is best? - Giant PANDA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •TRIAL INCLUSION CRITERIA:
- •-Pregnancy 11+0 and 34+0 weeks’ gestation inclusive
- •-Diagnosis of pregnancy hypertension (chronic/gestational hypertension or pre-eclampsia)
- •-Clinician decision to initiate or continue use of antihypertensive drugs
- •-Aged 18 years or over
- •-Able to give informed consent
- •OBSERVATIONAL STUDY INCLUSION CRITERIA:
- •Women will be eligible to participant in the observational study at any gestational age up to and including 34+0 weeks. Women are able to take part in the observational study prior to 11+0 weeks gestation where use of any antihypertensive drugs prescribed in clinical care will be recorded but will not form part of the interventional trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •TRIAL EXCLUSION CRITERIA:
- •-Contraindication to either labetalol or nifedipine
- •-Already taking both labetalol and nifedipine, and not able to be randomised to a single drug
- •OBSERVATIONAL STUDY EXCLUSION CRITERIA:
- •Neither exclusion criterion for the trial are relevant for the observational study. Women contraindicated to either labetalol or nifedipine and/or women already taking both labetalol and nifedipine and not able to be randomised to a single drug, are eligible for the observational study.
研究者
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