Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05637151
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535932', 'term': 'Intrahepatic Cholestasis of Pregnancy'}, {'id': 'D007567', 'term': 'Jaundice, Neonatal'}], 'ancestors': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2022-11-28', 'studyFirstSubmitQcDate': '2022-11-28', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the neonatal bilirubin values', 'timeFrame': '2-4 days after birth', 'description': 'the neonatal bilirubin values'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrahepatic cholestasis during pregnancy', 'neonatal bilirubin', 'bilirubin', 'ICP', 'neonatal jaundice'], 'conditions': ['Intrahepatic Cholestasis of Pregnancy']}, 'descriptionModule': {'briefSummary': 'Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.\n\nMethod:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The pregnant woman is born at a gestational age of 37-40 weeks;\n2. The pregnant woman has a single child;\n3. Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).\n\nExclusion Criteria:\n\n1. Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;\n2. Insufficiency of vital organ function or complicated tumor;\n3. Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.'}, 'identificationModule': {'nctId': 'NCT05637151', 'briefTitle': 'Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2022-07-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ICC in pregnant women with ICP', 'description': 'Immediate cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy', 'interventionNames': ['Other: clamp time of umbilical']}, {'type': 'EXPERIMENTAL', 'label': 'DCC in pregnant women with ICP', 'description': 'Delayed cord clamping group in pregnant women with intrahepatic cholestasis of pregnancy', 'interventionNames': ['Other: clamp time of umbilical']}, {'type': 'OTHER', 'label': 'ICC in normal pregnant women', 'description': 'Immediate cord clamping group in normal pregnant women', 'interventionNames': ['Other: clamp time of umbilical']}, {'type': 'EXPERIMENTAL', 'label': 'DCC in normal pregnant women', 'description': 'Delayed cord clamping group in normal pregnant women', 'interventionNames': ['Other: clamp time of umbilical']}], 'interventions': [{'name': 'clamp time of umbilical', 'type': 'OTHER', 'description': 'The umbilical cord was clamped immediately or late for more than 30s', 'armGroupLabels': ['DCC in normal pregnant women', 'DCC in pregnant women with ICP', 'ICC in normal pregnant women', 'ICC in pregnant women with ICP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ying hua', 'role': 'CONTACT', 'email': 'wzfeyhy1015@126.com', 'phone': '+8613676403165'}], 'facility': 'department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Ying Hua', 'role': 'CONTACT', 'email': 'wzfeyhy1015@126.com', 'phone': '+8613676403165', 'phoneExt': '+8613676403165'}], 'overallOfficials': [{'name': 'Ying Hua', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}