Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT06405867
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Importance of Delayed Cord Clamping
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D011086', 'term': 'Polycythemia'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087526', 'term': 'Umbilical Cord Clamping'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This was a single-center, with block randomisation \\[1:1\\], open-label, parallel group study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron deficiency anemia', 'timeFrame': '4 months', 'description': 'In terms of iron deficiency anemia, hb \\< 11 g/dl and transferrin saturation \\< 15% criteria were taken as basis'}, {'measure': 'Polycythemia and indirect hyperbilirubinemia', 'timeFrame': '4 months', 'description': 'Polycythemia was defined by venous hematocrit above 65%. Hyperbilirubinemia was defined as the nomogram being above the phototherapy threshold value.'}], 'secondaryOutcomes': [{'measure': 'Postpartum hemorrhage', 'timeFrame': '7 days', 'description': 'Postpartum bleeding greater than 500 ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delayed cord clamping', 'hypothermia', 'polycythemia', 'iron deficiency anemia'], 'conditions': ['Newborn; Vitality', 'Iron Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '29794839', 'type': 'RESULT', 'citation': 'Fenton C, McNinch NL, Bieda A, Dowling D, Damato E. Clinical Outcomes in Preterm Infants Following Institution of a Delayed Umbilical Cord Clamping Practice Change. Adv Neonatal Care. 2018 Jun;18(3):223-231. doi: 10.1097/ANC.0000000000000492.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.2147/IJWH.S385800', 'label': "The Short and Long Term Consequences of Delayed Cord Clamping on Late Pre-Term Infants. International journal of women's health"}]}, 'descriptionModule': {'briefSummary': 'After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn.\n\nIncreased bleeding control, which is reported as a maternal complication, has not been found in studies. Approximately 28ml/kg additional blood volume is transferred to the baby with placental transfusion. The hemodynamics of the newborn are positively affected as the blood volume increases the right ventricular volume and the pulmonary pressure begins to decrease with the first breath. In addition, due to this additional blood volume, stem cells and erythrocytes pass through more. There are studies showing that it reduces iron deficiency that occurs in infants at the 4th month. In our study, we aimed to examine the effect of allowing placental transfusion until cord pulsation stopped and the effect of delayed cord clamping on iron deficiency at the 4th month in babies.', 'detailedDescription': "Healthy term newborns who will be born in our gynecology clinic; type of birth, week of gestation, birth weight, cord clamping time, cord blood gas, APGAR score, complete blood count, maternal complete blood count, maternal complications, baby's first body temperature, postnatal day 3 hematocrit and bilirubin level, diet, phototherapy treatment application Measurements will be determined and evaluated in terms of the baby's condition, monthly routine baby follow-up (anthropometric measurements and physical examination), and routine 4th month iron deficiency screening. These measurements and applications will be made by the baby nurse, pediatric assistant and pediatrician who will be present during the birth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The healthy babies of healthy mothers (no pre-eclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) term (gestational age ≥ 37 weeks) and no additional abnormality were included in the study.\n\nExclusion Criteria:\n\n* . Babies who needed resuscitation were excluded from the study'}, 'identificationModule': {'nctId': 'NCT06405867', 'briefTitle': 'The Importance of Delayed Cord Clamping', 'organization': {'class': 'OTHER', 'fullName': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}, 'officialTitle': 'The Importance of Delayed Cord Clamping: do we Know', 'orgStudyIdInfo': {'id': 'SYNEO-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early cord clamping (< 30 sec)', 'description': "Regardless of the type of delivery, a stopwatch was started to determine the clamping time by visualizing the baby's shoulder. No intervention was made to the health personnel who gave birth in the ECC group. Routinely, one clamp was clamped close to the baby's umbilicus and the other on the mother's side, with a distance of approximately 5 cm from the first clamp and cut between the two clamps. Cord clamping time was noted on the case report form", 'interventionNames': ['Procedure: delayed cord clamping (> 60 sec)']}], 'interventions': [{'name': 'delayed cord clamping (> 60 sec)', 'type': 'PROCEDURE', 'otherNames': ['cord clamping time'], 'description': "In the DCC group, cord pulse was checked without allowing clamping. Waited until the cord pulse stopped. It was wrapped in a sterile and warm cloth and dried. The cord was clamped when the pulse stopped. The cord clamping time was noted on the case report form. In DCC, the baby was placed on the mother's legs in cesarean section (C/S) births and on the mother's mons pubis region in normal vaginal births. The baby was administered a routine delivery room neonatal resuscitation program (NRP) by the pediatrician. After cord clamping, the baby was handed over to the pediatric team.", 'armGroupLabels': ['Early cord clamping (< 30 sec)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34730', 'city': 'Istanbul', 'state': 'N/A (n/a)', 'country': 'Turkey (Türkiye)', 'facility': 'Goztepe Prof Dr. Suleyman Yalcın City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Fahri Ovalı, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'İstanbul medeniyet faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goztepe Prof Dr Suleyman Yalcın City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pediatric clinic chief assistant, MD', 'investigatorFullName': 'Sibel Sevuk Ozumut', 'investigatorAffiliation': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}}}}