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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hyperemesis Gravidarum, Pregnancy Related

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperemesis gravidarum<br>pregnant women before 14 weeks of pregnancy diagnosed with hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal. | |
| Healthy pregnant women<br>Healthy pregnant women before 14 weeks of pregnancy without hyperemesis gravidarum will be assessed in terms of gallbladder functions and serum cholecystokinin levels after a fatty meal. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Gallbladder (GB) Wall Thickness | GB wall thickening measured with abdominal ultrasound at fasting and postprandial | fasting and postprandial 45th minute | 
| Gallbladder (GB) Volume | volume of GB measured with abdominal ultrasound at fasting and postprandial | fasting and postprandial 45th minute | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallbladder functions, cholecystokinin, hyperemesis gravidarum