跳至主要内容
临床试验/NCT03950167
NCT03950167已完成不适用

Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum

Müge Keskin1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2019年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
325
试验地点
1
主要终点
Blood Cholecystokinin (CCK) Levels

研究概览

简要总结

This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. Two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.

详细描述

Previously gallbladder functions have been observed in human with gallbladder disease. However it has never been evaluated whether there is any difference in gallbladder functions between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum. Moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions has never been assessed. There is also few data comparing serum cholecystokinin levels between healthy pregnant women and those diagnosed with hyperemesis gravidarum. The investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate) and compare two groups. In this study the investigators would like to evaluate gallbladder functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare these with healthy subjects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • gestation week between 6 and 14 weeks,
  • singleton pregnancy with a live embryo,
  • healthy women without any medical disorders,
  • Exclusion Criteria
  • any systemic disease,
  • gallbladder disease
  • any psychological disorder that can cause vomiting,
  • multiple gestation

排除标准

  • 未提供

结局指标

主要结局

Blood Cholecystokinin (CCK) Levels

时间窗: Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level

a gut hormone released, its level can be measured in blood as fasting level and postprandial

Gallbladder (GB) Ejection Fraction

时间窗: The fasting and postprandial 45th minute

GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage

Gallbladder (GB) Volume

时间窗: fasting and postprandial 45th minute

volume of GB measured with abdominal ultrasound at fasting and postprandial

Gallbladder (GB) Wall Thickness

时间窗: fasting and postprandial 45th minute

GB wall thickening measured with abdominal ultrasound at fasting and postprandial

次要结局

未报告次要终点

研究者

发起方
Müge Keskin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Müge Keskin

Principal investigator

Ufuk University

研究点 (1)

Loading locations...

相似试验