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

Completed

• Conditions: Hyperemesis Gravidarum; Pregnancy Related

• Registration Number: NCT03950167
• Lead Sponsor: Müge Keskin

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-03-26
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-12
• Study First Posted: 2019-05-15
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Results First Submitted: 2021-05-03
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Results First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 325

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Cholecystokinin (CCK) Levels	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	The fasting and postprandial 45th minute	GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage
Gallbladder (GB) Volume	fasting and postprandial 45th minute	volume of GB measured with abdominal ultrasound at fasting and postprandial
Gallbladder (GB) Wall Thickness	fasting and postprandial 45th minute	GB wall thickening measured with abdominal ultrasound at fasting and postprandial

Trial Locations

Locations (1)

Ufuk University Hospital; 🇹🇷 Ankara, Turkey