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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Muge Keskin | Ufuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ufuk University Hospital | Ankara | Turkey (Türkiye) |
Excluded (n=275)
This is a prospective cohort study conducted in Ufuk University hospital, Ankara, Turkey (a tertiary center) between March 2019 and May 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PREGNANT WOMEN DİAGNOSED WITH HYPEREMESİS GRAVIDARUM AND HEALTHY PREGNANT WOMEN
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Healthy Pregnant Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | women aged between 18-40 were recruited |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Cholecystokinin (CCK) Levels | a gut hormone released, its level can be measured in blood as fasting level and postprandial | Posted | Mean | Standard Deviation | picogram/mililiters (pg/ml) | Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level |
|
1 year 6 months
a fatty test meal (100 g milk chocolate) was given to all participants for the evaluation of postprandial cholecystokinin levels and gallbladder parameters including volume and gallbladder wall thickness. Nausea and vomiting are the possible adverse events that may have been observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomitting | Gastrointestinal disorders | Systematic Assessment | Nausea and vomiting after fatty meal (100 g milk chocolate) |
Lack of power analysis and inclusion of few patients after assessing eligibility for the study are the limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR MÜGE KESKİN | UFUK UNIVERSITY | +905333522090 | mugekeskin1@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2021 | Sep 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2019 | Nov 25, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006939 | Hyperemesis Gravidarum |
| ID | Term |
|---|---|
| D048968 | Morning Sickness |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Blood samples
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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| age | Age, continuous | Mean | Standard Deviation | years |
|
| body mass index (BMI) | weight in kilograms divided by the square of height in meters | Mean | Standard Deviation | kg/m² |
|
| gravidity | the number of times that a woman has been pregnant | Median | Inter-Quartile Range | gravidity |
|
| Gestational age | description of how far along the pregnancy is. It is measured in weeks | Median | Full Range | weeks |
|
| parity | the number of times that a woman has given birth a fetus with a gestational age of 24 weeks or more | Median | Inter-Quartile Range | parity |
|
|
|
|
| Primary | Gallbladder (GB) Wall Thickness | GB wall thickening measured with abdominal ultrasound at fasting and postprandial | Posted | Mean | Standard Deviation | milimeters (mm) | fasting and postprandial 45th minute |
|
|
|
|
| Primary | Gallbladder (GB) Volume | volume of GB measured with abdominal ultrasound at fasting and postprandial | Posted | Mean | Standard Deviation | mililiter (ml) | fasting and postprandial 45th minute |
|
|
|
|
| Primary | Gallbladder (GB) Ejection Fraction | GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage | Posted | Mean | Standard Deviation | Percantage (%) | The fasting and postprandial 45th minute |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
|
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| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| t-test, 2 sided |
| 0.05 |
A p value of <0.05 was accepted as significant in all statistical analyses. |
| Mean Difference (Final Values) |
| 0.23 |
| 2-Sided |
p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group |
| Other |
| t-test, 2 sided |
| 0.05 |
A p value of <0.05 was accepted as significant in all statistical analyses. |
| Mean Difference (Final Values) |
| 0.71 |
| 2-Sided |
p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group |
| Other |
| t-test, 2 sided |
| 0.05 |
A p value of <0.05 was accepted as significant in all statistical analyses. |
| Mean Difference (Final Values) |
| 0.63 |
| 2-Sided |
p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group |
| Other |