EUCTR2015-005811-34-NL进行中（未招募）1 期
Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial) - PLATINA
VU Medical Center, Amsterdam0 个研究点目标入组 472 人开始时间: 2018年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 472
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
- •In order to be eligible to participate in this study, a subject must meet the following criteria:
- •-Pregnant women
- •->18 years of age
- •-pregnant women with severe pregnancy induced hypertension (PIH) or severe pre-eclampsia (PE) at any gestational age. Preeclampsia is defined as hypertension with proteinuria = 0.3 g/24 hrs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 472
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Maternal age at eligibility <18 years
- •- Fetal abnormalities
- •- Multiple pregnancy in current pregnancy
- •- Clinically relevant pulmonary edema, defined as pulmonary failure or distress requiring oxygen supplementation (more than 10 liters) and/or pulse oximetry of <94%.
研究者
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