Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT03907605
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2019-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054304', 'term': 'Anti-Mullerian Hormone'}], 'ancestors': [{'id': 'D013735', 'term': 'Testicular Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-06', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-06', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1- Anti-Mullerian Hormone levels variation', 'timeFrame': '3 months', 'description': 'Anti-Mullerian Hormone levels before and 3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-Mullerian Hormone Deficiency', 'Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. There are many studies about AMH changes in ovarian surgery, but little is known for other surgeries. We seek to investigate the hormone variations before and after uterine artey ligation for postpartum hemorrage (PPH)', 'detailedDescription': 'All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who need artery ligation for PPH during C-section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18- 40 years\n* no systemic or endocrine diseases\n* patients who had uterine artery ligation due to PPH\n\nExclusion Criteria:\n\n* Pregnancy with IVF or oosit donation\n* Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.\n* Patients with BMI \\>40'}, 'identificationModule': {'nctId': 'NCT03907605', 'briefTitle': 'Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Comparison of Serum Anti-Mullerian Hormone Levels Following Uterine Artery Ligation for PPH.', 'orgStudyIdInfo': {'id': 'amhpph'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anti- mullerian hormone', 'type': 'OTHER', 'description': 'All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pinar Yalcin Bahat', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pınar Yalcin bahat', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}