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

M

Müge Keskin

Status

Completed

Conditions

Pregnancy Related
Hyperemesis Gravidarum

Study type

Observational

Funder types

Other

Identifiers

NCT03950167
20190328

Details and patient eligibility

About

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.

Full 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.

Enrollment

325 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

325 participants in 2 patient groups

Hyperemesis gravidarum
Description:
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
Description:
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.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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