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临床试验/EUCTR2015-005811-34-NL
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

发起方
VU Medical Center, Amsterdam

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