Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01393834
Status:
TERMINATED
Last Update Posted:
2013-02-22
First Post:
2011-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'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'}]}, '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'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'difficulty with enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2011-06-01', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Neonatal Event', 'timeFrame': 'up to 24 weeks after birth', 'description': 'composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home'}], 'secondaryOutcomes': [{'measure': 'Maternal estimated blood loss', 'timeFrame': 'up to 1 hour after delivery', 'description': 'Estimated blood loss at delivery'}, {'measure': 'Any grade intraventricular hemorrhage', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Severe intraventricular hemorrhage (grade 3 or 4)', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Periventricular leukomalacia', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Peak transcutaneous and/or serum bilirubin concentrations', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Phototherapy', 'timeFrame': 'up to 24 weeks after birth', 'description': 'Requirement and length of phototherapy'}, {'measure': 'Ionotropic support', 'timeFrame': 'up to 24 weeks after birth', 'description': 'Requirement and length of ionotropic support'}, {'measure': 'Neonatal intesive care unit (NICU) length of stay', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Sepsis', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Necrotizing enterocolitis', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Respiratory distress syndrome', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Number of blood transfusions while in the neonatal intensive care unit', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Ventilator time', 'timeFrame': 'up to 24 weeks after birth'}, {'measure': 'Apgar score <7 at 5 minutes', 'timeFrame': 'at 5 minutes after birth'}, {'measure': 'Umbilical cord pH < 7.0', 'timeFrame': 'up to 30 minutes after birth'}, {'measure': 'Blood pressure on admission to neonatal intensive care unit', 'timeFrame': 'at 30 minutes after birth'}, {'measure': 'Polycythemia', 'timeFrame': 'up to 24 hours of life'}, {'measure': 'Hematocrit on admission to neonatal intensive care unit', 'timeFrame': 'up to 4 hours after birth'}, {'measure': 'Neonatal death', 'timeFrame': 'up to 24 weeks of life'}, {'measure': 'Length of 3rd stage of labor', 'timeFrame': 'up to 1 hour after birth', 'description': 'Time period between delivery of the baby and delivery of the placenta'}, {'measure': 'Use of uterotonic agents', 'timeFrame': 'up to 1 hour after birth'}, {'measure': 'Maternal blood transfusion', 'timeFrame': 'up to 5 days after delivery'}, {'measure': 'Manual removal of placenta', 'timeFrame': 'up to 1 hour after birth'}, {'measure': 'Operating time for cesarean delivery', 'timeFrame': 'up to 3 hours after birth'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delayed cord clamping', 'Umbilical cord', 'Preterm', 'Cord milking'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation\n* Women ages 18 and older\n\nExclusion Criteria:\n\n* Planned vaginal breech delivery\n* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)\n* Fetal death in utero\n* Red cell isoimmunization\n* Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization\n* Placenta previa or other known abnormal placentation (e.g. placenta accreta)'}, 'identificationModule': {'nctId': 'NCT01393834', 'briefTitle': 'Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '2011-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delayed cord clamping', 'description': 'Delayed cord clamping for 30 seconds', 'interventionNames': ['Procedure: Delayed cord clamping']}, {'type': 'EXPERIMENTAL', 'label': 'Milking of the cord', 'description': 'Milking of the cord 4 times in 10 seconds', 'interventionNames': ['Procedure: Milking of the cord']}, {'type': 'NO_INTERVENTION', 'label': 'Immediate cord clamping', 'description': 'Immediate cord clamping after delivery'}], 'interventions': [{'name': 'Delayed cord clamping', 'type': 'PROCEDURE', 'description': 'Delay cord clamping for 30 seconds after birth', 'armGroupLabels': ['Delayed cord clamping']}, {'name': 'Milking of the cord', 'type': 'PROCEDURE', 'description': 'Milking of the cord 4 times in 10 seconds', 'armGroupLabels': ['Milking of the cord']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rita W Driggers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Hospital Center, Georgetown University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}