Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03950167
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2019-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006939', 'term': 'Hyperemesis Gravidarum'}], 'ancestors': [{'id': 'D048968', 'term': 'Morning Sickness'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mugekeskin1@hotmail.com', 'phone': '+905333522090', 'title': 'DR MÜGE KESKİN', 'organization': 'UFUK UNIVERSITY'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Lack of power analysis and inclusion of few patients after assessing eligibility for the study are the limitations.'}}, 'adverseEventsModule': {'timeFrame': '1 year 6 months', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': '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.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '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.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea and vomitting', 'notes': 'Nausea and vomiting after fatty meal (100 g milk chocolate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Cholecystokinin (CCK) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.'}, {'id': 'OG001', 'title': '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.'}], 'classes': [{'title': 'fasting CCK', 'categories': [{'measurements': [{'value': '53.13', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '54.55', 'spread': '25.32', 'groupId': 'OG001'}]}]}, {'title': 'postprandial CCK', 'categories': [{'measurements': [{'value': '73.61', 'spread': '30.29', 'groupId': 'OG000'}, {'value': '81.24', 'spread': '29.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.85', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.68', 'estimateComment': 'p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group', 'groupDescription': 'Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level', 'description': 'a gut hormone released, its level can be measured in blood as fasting level and postprandial', 'unitOfMeasure': 'picogram/mililiters (pg/ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gallbladder (GB) Wall Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.'}, {'id': 'OG001', 'title': '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.'}], 'classes': [{'title': 'fasting GB wall thickness', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'postprandial GB wall thickness', 'categories': [{'measurements': [{'value': '2.51', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.91', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.23', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'fasting and postprandial 45th minute', 'description': 'GB wall thickening measured with abdominal ultrasound at fasting and postprandial', 'unitOfMeasure': 'milimeters (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gallbladder (GB) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.'}, {'id': 'OG001', 'title': '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.'}], 'classes': [{'title': 'fasting GB volume', 'categories': [{'measurements': [{'value': '36.9', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '33.69', 'spread': '12.54', 'groupId': 'OG001'}]}]}, {'title': 'postprandial GB volume', 'categories': [{'measurements': [{'value': '17.29', 'spread': '8.14', 'groupId': 'OG000'}, {'value': '18.33', 'spread': '6.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.41', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.71', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'fasting and postprandial 45th minute', 'description': 'volume of GB measured with abdominal ultrasound at fasting and postprandial', 'unitOfMeasure': 'mililiter (ml)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Gallbladder (GB) Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '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.'}, {'id': 'OG001', 'title': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.06', 'spread': '19.45', 'groupId': 'OG000'}, {'value': '45.46', 'spread': '16.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.22', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.63', 'pValueComment': 'A p value of \\<0.05 was accepted as significant in all statistical analyses.', 'estimateComment': 'p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The fasting and postprandial 45th minute', 'description': 'GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage', 'unitOfMeasure': 'Percantage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '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.'}, {'id': 'FG001', 'title': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This is a prospective cohort study conducted in Ufuk University hospital, Ankara, Turkey (a tertiary center) between March 2019 and May 2020.', 'preAssignmentDetails': 'Excluded (n=275)\n\n* Not meeting inclusion criteria (n=163) Inclusion criteria were: gestation week between 6 and 14 weeks, singleton pregnancy with a live embryo, age range between 18 and 40 years, healthy women without any medical disorders, Women with any systemic disease, gallbladder disease or any psychological disorder that can cause vomiting, multiple gestation were excluded.\n* Declined to participate (n=112)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '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.'}, {'id': 'BG001', 'title': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.08', 'spread': '4.03', 'groupId': 'BG000'}, {'value': '30.91', 'spread': '4.20', 'groupId': 'BG001'}, {'value': '30.49', 'spread': '2.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'women aged between 18-40 were recruited', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'age', 'classes': [{'categories': [{'measurements': [{'value': '30.91', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '30.08', 'spread': '4.03', 'groupId': 'BG001'}, {'value': '30.49', 'spread': '4.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age, continuous', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.95', 'spread': '3.53', 'groupId': 'BG000'}, {'value': '24.55', 'spread': '4.72', 'groupId': 'BG001'}, {'value': '24.25', 'spread': '4.125', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'weight in kilograms divided by the square of height in meters', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'gravidity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': 'the number of times that a woman has been pregnant', 'unitOfMeasure': 'gravidity', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'groupId': 'BG000', 'lowerLimit': '6.14', 'upperLimit': '13'}, {'value': '8.92', 'groupId': 'BG001', 'lowerLimit': '6.28', 'upperLimit': '13.5'}, {'value': '8.995', 'groupId': 'BG002', 'lowerLimit': '6.21', 'upperLimit': '13.25'}]}]}], 'paramType': 'MEDIAN', 'description': 'description of how far along the pregnancy is. It is measured in weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}, {'title': 'parity', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'description': 'the number of times that a woman has given birth a fetus with a gestational age of 24 weeks or more', 'unitOfMeasure': 'parity', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'PREGNANT WOMEN DİAGNOSED WITH HYPEREMESİS GRAVIDARUM AND HEALTHY PREGNANT WOMEN'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-26', 'size': 105616, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-27T11:22', 'hasProtocol': True}, {'date': '2019-03-26', 'size': 111194, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-11-25T09:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2019-04-30', 'resultsFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2019-05-12', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-25', 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Cholecystokinin (CCK) Levels', 'timeFrame': 'Fasting (baseline) and postprandial (15 minutes after the test meal) CCK level', 'description': 'a gut hormone released, its level can be measured in blood as fasting level and postprandial'}, {'measure': 'Gallbladder (GB) Wall Thickness', 'timeFrame': 'fasting and postprandial 45th minute', 'description': 'GB wall thickening measured with abdominal ultrasound at fasting and postprandial'}, {'measure': 'Gallbladder (GB) Volume', 'timeFrame': 'fasting and postprandial 45th minute', 'description': 'volume of GB measured with abdominal ultrasound at fasting and postprandial'}, {'measure': 'Gallbladder (GB) Ejection Fraction', 'timeFrame': 'The fasting and postprandial 45th minute', 'description': 'GB ejection fraction measures how much bile gallbladder releases at one time, expressed as percentage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gallbladder functions', 'cholecystokinin', 'hyperemesis gravidarum'], 'conditions': ['Hyperemesis Gravidarum', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14 weeks of pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestation week between 6 and 14 weeks,\n* singleton pregnancy with a live embryo,\n* healthy women without any medical disorders,\n\nExclusion Criteria\n\n* any systemic disease,\n* gallbladder disease\n* any psychological disorder that can cause vomiting,\n* multiple gestation'}, 'identificationModule': {'nctId': 'NCT03950167', 'briefTitle': 'Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'Gallbladder Functions & Serum Cholecystokinin Levels in Pregnant Women Diagnosed With Hyperemesis Gravidarum', 'orgStudyIdInfo': {'id': '20190328'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.'}, {'label': '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.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ufuk University Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Muge Keskin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ufuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Müge Keskin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Müge Keskin', 'investigatorAffiliation': 'Ufuk University'}}}}