Hyperemesis GravidarumNCT03950167
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
An observational study of Hyperemesis Gravidarum and Pregnancy Related, run by Müge Keskin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperemesis Gravidarum, Pregnancy Related
- How many people
- 325 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2019to 15 May 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy
Who may be able to join
- gestation week between 6 and 14 weeks,
- singleton pregnancy with a live embryo,
- healthy women without any medical disorders,
Who cannot join
- any systemic disease,
- gallbladder disease
- any psychological disorder that can cause vomiting,
- multiple gestation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant 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.
Read the 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.
- Conditions
- Hyperemesis Gravidarum, Pregnancy Related
- Keywords
- gallbladder functions, cholecystokinin, hyperemesis gravidarum
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Cholecystokinin (CCK) Levels
a gut hormone released, its level can be measured in blood as fasting level and postprandial
Measured: 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
Measured: fasting and postprandial 45th minute
Gallbladder (GB) Volume
volume of GB measured with abdominal ultrasound at fasting and postprandial
Measured: fasting and postprandial 45th minute
Gallbladder (GB) Ejection Fraction
GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage
Measured: The fasting and postprandial 45th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start26 Mar 2019
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Müge Keskin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Müge Keskin, Ufuk University
- Investigators
- Muge Keskin, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950167
- Sponsor's protocol ID
- 20190328
- Status last verified
- Nov 2021
- First submitted
- 30 Apr 2019
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT03950167
- Acronym / sponsor ID
- 20190328
- Conditions
- Hyperemesis Gravidarum, Pregnancy Related
- Keywords
- gallbladder functions, cholecystokinin, hyperemesis gravidarum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Müge KeskinUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy
Key inclusion criteria (3 listed)
- gestation week between 6 and 14 weeks,
- singleton pregnancy with a live embryo,
- healthy women without any medical disorders,
Key exclusion criteria (4 listed)
- any systemic disease,
- gallbladder disease
- any psychological disorder that can cause vomiting,
- multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Gallbladder (GB) Wall Thickness
Time frame: fasting and postprandial 45th minute
GB wall thickening measured with abdominal ultrasound at fasting and postprandial
Gallbladder (GB) Volume
Time frame: fasting and postprandial 45th minute
volume of GB measured with abdominal ultrasound at fasting and postprandial
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Hyperemesis Gravidarum Risk Reduction With Metformin
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muge Keskin principal investigator
Ufuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperemesis Gravidarum and Pregnancy Related, run by Müge Keskin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Cholecystokinin (CCK) Levels (time frame: Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.