Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-23 @ 4:52 AM
Study NCT ID:
NCT01987869
Status:
UNKNOWN
Last Update Posted:
2013-11-19
First Post:
2013-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-11-13', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ıs there any assosiation between other serum parameters includes estrogen,progesterone and serum beta hcg', 'timeFrame': '6-14week pregnancy'}], 'primaryOutcomes': [{'measure': 'serum serotonin levels in hiperemezis gravidarum', 'timeFrame': '6-14week pregnancy'}], 'secondaryOutcomes': [{'measure': 'ıs there any assosiation between serotonin levels and severity of symptoms in pregnant women with hiperemezis', 'timeFrame': '6-14week pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hiperemesis gravidarum,vomiting,serotonin levels,ketonuria'], 'conditions': ['Nausea', 'Vomiting', 'Markedly Reduced Food Intake', 'Severe Dehydration']}, 'descriptionModule': {'briefSummary': 'Serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.', 'detailedDescription': 'The occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. Although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. Many theories have been advocated, but to date none of these have been convincing.\n\nIt has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. This has provided a rationale for the treatment of these symptoms with specific serotonin antagonists.\n\nThe aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women between six and fourteen weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-14 week pregnant women\n* nausea\n* protracted vomiting\n* inability to tolerate food intake accompanied by obvious dehydration\n* severe enough to justify hospitalisation\n* at least 2+ ketonuria on dipstick urinanalysis.\n\nExclusion Criteria:\n\n* with metabolic disorders such as diabet, thyroid'}, 'identificationModule': {'nctId': 'NCT01987869', 'briefTitle': 'Hiperemezis and Serotonin Elevated Serum Serotonin Levels in Hyperemesis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Relationship Between Elevated Serum Serotonin Levels in Symptomatic Patients With Hyperemezis', 'orgStudyIdInfo': {'id': '2013-88'}}, 'contactsLocationsModule': {'locations': [{'zip': '34140', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'hediye dagdeviren, md', 'role': 'CONTACT', 'email': 'hediyedagdeviren@gmail.com', 'phone': '5079872463'}, {'name': 'huseyin cengiz, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bakirkoy Dr Sadi Konuk Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'hediye dağdeviren, md', 'role': 'CONTACT', 'email': 'hediyedagdeviren@gmail.com', 'phone': '5079872463'}], 'overallOfficials': [{'name': 'hüseyin cengiz, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Bakırkoy Dr. Sadi Konuk Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}