跳至主要内容
临床试验/EUCTR2018-002285-39-DK
EUCTR2018-002285-39-DK进行中(未招募)1 期

Validating the Effect of Ondansetron and Mirtazapine In Treating Hyperemesis Gravidarum. A Double-blind Randomized Placebo-Controlled Multicentre Trial. - VOMIT

Department of Gynaecology and Obstetrics Nordsjællands Hospital0 个研究点目标入组 180 人开始时间: 2018年9月25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
180

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

  • Pregnant with gestational age between 5+0 and 19+6
  • Nausea and vomiting without other obvious reason
  • PUQE-24 score =13 OR
  • PUQE-24 score =7 AND
  • 1.weight loss >5% of pre-pregnancy weight OR
  • 2.hospitalisation due to nausea and vomiting of pregnancy
  • Normal singleton pregnancy
  • 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 180
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Mola-, multiple- or non-vital pregnancy
  • Congenital long QT-syndrome
  • Ongoing treatment with antidepressant medication
  • Not able to take medicine orally
  • Not able to understand spoken and written Danish

研究者

发起方
Department of Gynaecology and Obstetrics Nordsjællands Hospital

相似试验