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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Hyperemesis Gravidarum

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 Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ufuk University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hyperemesis gravidarum; 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; 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?

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

Collaborators and Investigators

• Sponsor: Müge Keskin
• Investigators: Principal Investigator: Muge Keskin, Ufuk University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 12, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: hyperemesis gravidarum; gallbladder functions; cholecystokinin
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pregnancy Complications; Morning Sickness; Vomiting; Hyperemesis Gravidarum
• Other Study ID Numbers: 20190328

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No