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

NCT ID: NCT03950167

Last Updated: 2021-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-26

Study Completion Date

2020-05-15

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.

Conditions

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Hyperemesis Gravidarum Pregnancy Related

Keywords

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gallbladder functions cholecystokinin hyperemesis gravidarum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Müge Keskin

OTHER

Sponsor Role lead

Responsible Party

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Müge Keskin

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muge Keskin

Role: PRINCIPAL_INVESTIGATOR

Ufuk University

Locations

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Ufuk University Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20190328

Identifier Type: -

Identifier Source: org_study_id