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临床试验/EUCTR2017-003180-35-GB
EUCTR2017-003180-35-GB进行中(未招募)1 期

Feasibility study on the effects of postnatal enalapril on maternal cardiovascular function following preterm pre-eclampsia - PICk-UP

Manchester University NHS Foundation Trust0 个研究点目标入组 80 人开始时间: 2018年4月30日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
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 clinical trial of medicinal product

入排标准

入选标准

  • - Diagnosis of preterm pre-eclampsia (pPE) in this pregnancy requiring delivery <37 weeks gestation: new or worsening hypertension >20 weeks with proteinuria or other features suggestive of PE (abnormal haematological, biochemical parameters, fetal growth restriction and/or low PlGF)
  • Biochemical / haematological cut-offs:
  • - Platelet count <100 x109/L
  • - Alanine amino transferase > 50units/L
  • - Creatinine >90mmol/L
  • - Abdominal circumference (AC) / estimated fetal weight (EFW) <3rd centile
  • - Or 2 of the following:
  • - AC/EFW <10th centile
  • - AC/EFW crossing centiles by >2 quartiles
  • - Cerebroplacental ratio <5th centile
  • - Umbilical artery PI >95th centile
  • - At time of randomisation:
  • Postpartum, within 3 days of delivery
  • Aged 18 years or over
  • Able to provide informed consent
  • Serum creatinine <100 mmol/l
  • 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 80
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Inability to consent
  • Known cardiac disease
  • Contraindication to ACE inhibitors
  • Current ACE inhibitor / ARB use
  • Renal artery stenosis

研究者

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