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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03950167
Recruitment Status : Completed
First Posted : May 15, 2019
Results First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Müge Keskin, Ufuk University

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.

Condition or disease
Hyperemesis Gravidarum Pregnancy Related

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.

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Study Type : Observational
Actual Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum
Actual Study Start Date : March 26, 2019
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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.



Primary Outcome Measures :
  1. Blood Cholecystokinin (CCK) Levels [ Time Frame: 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

  2. Gallbladder (GB) Wall Thickness [ Time Frame: fasting and postprandial 45th minute ]
    GB wall thickening measured with abdominal ultrasound at fasting and postprandial

  3. Gallbladder (GB) Volume [ Time Frame: fasting and postprandial 45th minute ]
    volume of GB measured with abdominal ultrasound at fasting and postprandial

  4. Gallbladder (GB) Ejection Fraction [ Time Frame: The fasting and postprandial 45th minute ]
    GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950167


Locations
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Turkey
Ufuk University Hospital
Ankara, Turkey
Sponsors and Collaborators
Müge Keskin
Investigators
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Principal Investigator: Muge Keskin Ufuk University
  Study Documents (Full-Text)

Documents provided by Müge Keskin, Ufuk University:
Informed Consent Form  [PDF] March 26, 2019

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Responsible Party: Müge Keskin, Principal investigator, Ufuk University
ClinicalTrials.gov Identifier: NCT03950167    
Other Study ID Numbers: 20190328
First Posted: May 15, 2019    Key Record Dates
Results First Posted: November 30, 2021
Last Update Posted: November 30, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Müge Keskin, Ufuk University:
gallbladder functions
cholecystokinin
hyperemesis gravidarum
Additional relevant MeSH terms:
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Hyperemesis Gravidarum
Morning Sickness
Pregnancy Complications
Vomiting
Signs and Symptoms, Digestive