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NCT Number: NCT03950167

Gallbladder Functions & Serum Cholecystokinin Levels in 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.

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Key information

Conditions

Hyperemesis Gravidarum Female Urogenital Diseases and Pregnancy Complications Morning Sickness Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ufuk University Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Müge Keskin

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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