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

NCT03950167 | Completed Results DMC

• 1 other identifier: 20190328
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Pregnancy Related

Keywords

gallbladder functions; cholecystokinin; hyperemesis gravidarum

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• gestation week between 6 and 14 weeks,
• singleton pregnancy with a live embryo,
• healthy women without any medical disorders,

You may not qualify if:

• any systemic disease,
• gallbladder disease
• any psychological disorder that can cause vomiting,
• multiple gestation

Sponsors & Collaborators

• Müge Keskin: lead

Study Sites (1)

Ufuk University Hospital

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Lack of power analysis and inclusion of few patients after assessing eligibility for the study are the limitations.

Results Point of Contact

• Title: DR MÜGE KESKİN
• Organization: UFUK UNIVERSITY

mugekeskin1@hotmail.com

+905333522090

Study Officials

• Muge Keskin

  Ufuk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 15, 2019
• Study Start: March 26, 2019
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Locations

TU (1)