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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950167
• Other study ID #: 20190328
• Status: Completed
• Start date: March 26, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: November 2021
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Pregnancy Related

Locations

Country	Name	City	State
Turkey	Ufuk University Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Müge Keskin

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Cholecystokinin (CCK) Levels	a gut hormone released, its level can be measured in blood as fasting level and postprandial	Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level
Primary	Gallbladder (GB) Wall Thickness	GB wall thickening measured with abdominal ultrasound at fasting and postprandial	fasting and postprandial 45th minute
Primary	Gallbladder (GB) Volume	volume of GB measured with abdominal ultrasound at fasting and postprandial	fasting and postprandial 45th minute
Primary	Gallbladder (GB) Ejection Fraction	GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage	The fasting and postprandial 45th minute