Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-20 @ 12:43 AM
Study NCT ID:
NCT03624335
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Umbilical Cord Clamping Time in the Newborn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000751', 'term': 'Anemia, Neonatal'}, {'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trials comparing early and late cord clamping'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'haemoglobin', 'timeFrame': '6hours', 'description': 'haemoglobin level'}, {'measure': 'haemoglobin', 'timeFrame': '28 days', 'description': 'haemoglobin level'}, {'measure': 'haematocrit', 'timeFrame': '6 hours', 'description': 'haematocrit level'}, {'measure': 'haematocrit', 'timeFrame': '28 days', 'description': 'haematocrit level'}], 'secondaryOutcomes': [{'measure': 'serum ferritin', 'timeFrame': '6hours', 'description': 'serum ferritin level'}, {'measure': 'serum ferritin', 'timeFrame': '28days', 'description': 'serum ferritin level'}, {'measure': 'bilirubin', 'timeFrame': '6hours', 'description': 'bilirubin level'}, {'measure': 'bilirubin', 'timeFrame': '28days', 'description': 'bilirubin level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Umbilical cord clamping', 'Anemia Neonatal', 'Iron metabolism disorders'], 'conditions': ['Anemia Neonatal', 'Polycythemia Secondary', 'Hyperbilirubinemia, Neonatal']}, 'referencesModule': {'references': [{'pmid': '36126369', 'type': 'DERIVED', 'citation': 'Orenga-Orenga BJ, Gregori-Roig P, Real-Fernandez A, Donat-Colomer F, Sanchez-Thevenet P. Umbilical cord clamping time and maternal satisfaction. Midwifery. 2022 Dec;115:103487. doi: 10.1016/j.midw.2022.103487. Epub 2022 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.', 'detailedDescription': 'It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design.\n\nPatients are recruited by simple random sampling to one of the two intervention groups:\n\nGroup 1-ECC: Early clamping of the umbilical cord (before the first minute of life).\n\nGroup 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '35 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.\n\nExclusion Criteria:\n\n* monochorionic multiples\n* incarcerated mothers\n* placenta previa\n* concern for abruptions\n* Rh sensitization\n* hydrops\n* congenital anomalies\n* the obstetrician declining to perform the intervention'}, 'identificationModule': {'nctId': 'NCT03624335', 'briefTitle': 'Influence of Umbilical Cord Clamping Time in the Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate', 'orgStudyIdInfo': {'id': 'CORD STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ECC', 'description': 'In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.\n\nBlood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping', 'interventionNames': ['Procedure: ECC', 'Procedure: Blood Test 6hours', 'Procedure: Blood Test 24hours', 'Procedure: Blood Test 48hours', 'Procedure: Blood Test 28days']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: DCC', 'description': 'In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping', 'interventionNames': ['Procedure: DCC', 'Procedure: Blood Test 6hours', 'Procedure: Blood Test 24hours', 'Procedure: Blood Test 48hours', 'Procedure: Blood Test 28days']}], 'interventions': [{'name': 'ECC', 'type': 'PROCEDURE', 'description': 'Early clamping of the umbilical cord', 'armGroupLabels': ['Group 1: ECC']}, {'name': 'DCC', 'type': 'PROCEDURE', 'description': 'Delayed clamping of the umbilical cord', 'armGroupLabels': ['Group 2: DCC']}, {'name': 'Blood Test 6hours', 'type': 'PROCEDURE', 'description': 'Blood Test 6hours', 'armGroupLabels': ['Group 1: ECC', 'Group 2: DCC']}, {'name': 'Blood Test 24hours', 'type': 'PROCEDURE', 'description': 'Blood Test 24hours', 'armGroupLabels': ['Group 1: ECC', 'Group 2: DCC']}, {'name': 'Blood Test 48hours', 'type': 'PROCEDURE', 'description': 'Blood Test 48hours', 'armGroupLabels': ['Group 1: ECC', 'Group 2: DCC']}, {'name': 'Blood Test 28days', 'type': 'PROCEDURE', 'description': 'Blood Test 28days', 'armGroupLabels': ['Group 1: ECC', 'Group 2: DCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12540', 'city': 'Villarreal', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital Universitario de La Plana', 'geoPoint': {'lat': 38.72572, 'lon': -7.21533}}], 'overallOfficials': [{'name': 'Vanesa Rodenas, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Protocol study \\& Data Analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pascual Gregori Roig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario de la Plana', 'class': 'OTHER'}, {'name': 'FUNDACIÓN DAVALOS FLETCHER', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Adjunct Pediatrician of University Hospital of La Plana (Spain)', 'investigatorFullName': 'Pascual Gregori Roig', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}