Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03878602
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2019-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Umbilical Cord Clamping: What Are the Benefits
Sponsor:
Organization:
Raw JSON
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'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-15', 'size': 580844, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-15T10:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-22', 'studyFirstSubmitDate': '2019-03-14', 'resultsFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2019-03-15', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-22', 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Heart Rate After Delayed Umbilical Clamping', 'timeFrame': '5 minutes and 10 minutes after birth', 'description': 'It will be measured the change of heart rate (HR)'}, {'measure': 'Change of Saturation After Delayed Umbilical Clamping', 'timeFrame': '5 minutes and 10 minutes after birth', 'description': 'Saturation change (SpO2)'}, {'measure': 'Change of Temperature After Delayed Umbilical Clamping', 'timeFrame': '5 minutes after birth', 'description': 'Temperature change (T)'}], 'secondaryOutcomes': [{'measure': 'Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping', 'timeFrame': '120 minutes after birth', 'description': 'hemo gluco test (HGT)'}, {'measure': 'Misuration of the Hematocrit After Delayed Umbilical Clamping', 'timeFrame': '72 hours of life', 'description': 'hematocrit (Ht)'}, {'measure': 'Misuration of the Bilirubin After Delayed Umbilical Clamping', 'timeFrame': '72 hours of life', 'description': 'bilirubin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Newborn', 'Elective Caesaren Section', 'Cord Clamping'], 'conditions': ['Delayed Cord Clamping']}, 'referencesModule': {'references': [{'pmid': '30076109', 'type': 'RESULT', 'citation': 'Katheria A, Hosono S, El-Naggar W. A new wrinkle: Umbilical cord management (how, when, who). Semin Fetal Neonatal Med. 2018 Oct;23(5):321-326. doi: 10.1016/j.siny.2018.07.003. Epub 2018 Jul 20.'}, {'pmid': '23401615', 'type': 'RESULT', 'citation': 'Bhatt S, Alison BJ, Wallace EM, Crossley KJ, Gill AW, Kluckow M, te Pas AB, Morley CJ, Polglase GR, Hooper SB. Delaying cord clamping until ventilation onset improves cardiovascular function at birth in preterm lambs. J Physiol. 2013 Apr 15;591(8):2113-26. doi: 10.1113/jphysiol.2012.250084. Epub 2013 Feb 11.'}, {'pmid': '25689406', 'type': 'RESULT', 'citation': 'Polglase GR, Dawson JA, Kluckow M, Gill AW, Davis PG, Te Pas AB, Crossley KJ, McDougall A, Wallace EM, Hooper SB. Ventilation onset prior to umbilical cord clamping (physiological-based cord clamping) improves systemic and cerebral oxygenation in preterm lambs. PLoS One. 2015 Feb 17;10(2):e0117504. doi: 10.1371/journal.pone.0117504. eCollection 2015.'}, {'pmid': '30159064', 'type': 'RESULT', 'citation': 'Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.'}, {'pmid': '24843886', 'type': 'RESULT', 'citation': 'Ghavam S, Batra D, Mercer J, Kugelman A, Hosono S, Oh W, Rabe H, Kirpalani H. Effects of placental transfusion in extremely low birthweight infants: meta-analysis of long- and short-term outcomes. Transfusion. 2014 Apr;54(4):1192-8. doi: 10.1111/trf.12469.'}, {'pmid': '24901269', 'type': 'RESULT', 'citation': 'Backes CH, Rivera BK, Haque U, Bridge JA, Smith CV, Hutchon DJR, Mercer JS. Placental transfusion strategies in very preterm neonates: a systematic review and meta-analysis. Obstet Gynecol. 2014 Jul;124(1):47-56. doi: 10.1097/AOG.0000000000000324.'}, {'pmid': '25984654', 'type': 'RESULT', 'citation': 'Nevill E, Meyer MP. Effect of delayed cord clamping (DCC) on breathing and transition at birth in very preterm infants. Early Hum Dev. 2015 Jul;91(7):407-11. doi: 10.1016/j.earlhumdev.2015.04.013. Epub 2015 May 15.'}, {'type': 'RESULT', 'citation': 'Wafaa Taha Ibrahim Elgzar, Heba Abdel-Fatah Ibrahim, Hanan Heiba Elkhateeb."Effects of Deferred Versus Early Umbilical Cord Clamping on Maternal and Neonatal Outcomes" - American Journal of Nursing Research, 2017,5(4), 115-128'}, {'pmid': '22405491', 'type': 'RESULT', 'citation': 'Valero J, Desantes D, Perales-Puchalt A, Rubio J, Diago Almela VJ, Perales A. Effect of delayed umbilical cord clamping on blood gas analysis. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):21-3. doi: 10.1016/j.ejogrb.2012.01.020. Epub 2012 Mar 8.'}, {'pmid': '28114607', 'type': 'RESULT', 'citation': 'Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.'}, {'pmid': '24290868', 'type': 'RESULT', 'citation': 'Zhou YB, Li HT, Zhu LP, Liu JM. Impact of cesarean section on placental transfusion and iron-related hematological indices in term neonates: a systematic review and meta-analysis. Placenta. 2014 Jan;35(1):1-8. doi: 10.1016/j.placenta.2013.10.011. Epub 2013 Nov 20.'}, {'pmid': '23843134', 'type': 'RESULT', 'citation': 'McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.'}, {'pmid': '32448358', 'type': 'DERIVED', 'citation': 'De Bernardo G, Giordano M, De Santis R, Castelli P, Sordino D, Trevisanuto D, Buonocore G, Perrone S. A randomized controlled study of immediate versus delayed umbilical cord clamping in infants born by elective caesarean section. Ital J Pediatr. 2020 May 24;46(1):71. doi: 10.1186/s13052-020-00835-2.'}]}, 'descriptionModule': {'briefSummary': 'Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. Umbilical cord can be clamped within 30s or at least 1 min after birth. A lot of studies have shown that delayed umbilical cord clamping is associated with greater haemoglobin concentration, better iron storage between 3-6 months of life and lower incidence for transfusion and neonatal hypotension compared to immediate umbilical cord clumping. Newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Despite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section.', 'detailedDescription': 'Umbilical cord cutting determines the separation of the newborn from mother. Umbilical cord clumping consists in the binding of the umbilical cord by nipper to interrupt blood flow from placenta to foetus. In the spontaneous labor there are two modalities to obtain umbilical cord clamping: the first modality is immediate umbilical cord clamping within 30s from birth. The second modality is delayed umbilical cord clamping at least 1 min after birth. After 1 min, cerebral blood flow is reduced again because of lower cardiac output.\n\nA lot of studies have shown that delayed umbilical cord clamping is better than the early umbilical clamping because delayed umbilical cord clamping is associated with a great haemoglobin concentration in the newborns and best iron storage between 3-6 months of life and less incidence for transfusion and neonatal hypotension. Experimental studies, executed on animals and humans, analysed cardiocirculatory changes in the foetus immediately after birth and the importance of the delayed clamping for the hemodynamic stabilization, particularly in the lowest gestational age.\n\nIn a recent randomized study conducted in Nepal on 540 newborns, birth by eutocic delivery with 39.2 weeks of gestational age, showed that delayed umbilical cord clamping after 3 min of life is correlated with a better haemoglobin level and less incidence of anaemia at 8 months of life. Zhou et al. conducted a meta-analysis that included hematologic parameters obtained by umbilical cord, placenta and newborns blood.\n\nAssociation of Italian Hospital Gynecologists Obstetricians (AOGOI) declared contraindicated conditions to execute a delayed umbilical cord clamping:\n\nHypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of fetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest. Monochorionic twins, Fetal Hydrops, Umbilical cord damaged, Isoimmunization Rh.\n\nResearchers concluded that newborns subjected to Caesarean Section showed greater value of haemoglobin and lower value of red blood cells compared to newborns birth by vaginal delivery. Haematocrit difference was greater between newborns birth by elective Caesarean Section compared to those birth by Caesarean Section in labor. Nowadays, researchers found no side effects of delayed umbilical cord clamping except a slight increase of phototherapy needs.\n\nDespite evidence of beneficial effects for delayed umbilical cord clamping after eutocic delivery, this practice is not yet taken into consideration after elective Caesarean Section. The aim of the study protocol is to investigate the effects of the clamping after 1 min from birth by elective Caesarean Section on heart rate, saturation, body temperature, bilirubin, haematocrit and glycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Birth Body Weight = appropriate for gestational age\n* Delivery mode= Elective Caesarean Section\n* Mothers' BMI = 19-24,9\n* Mothers'age ≤ 37 years\n\nExclusion Criteria:\n\n* Admission in NICU;\n* Neonatal Resuscitation\n* Hypoxic-ischemic events: detachment of placenta, prolapse of the funiculus, uterine rupture, shoulder dystocia, premature rupture of foetal membranes, placenta previa, maternal collapse, embolism amniotic, maternal cardiac arrest\n* Pathologies ;\n* Smoking mothers;\n* Assumption of drugs during pregnancy\n* Mother toxicomaniac"}, 'identificationModule': {'nctId': 'NCT03878602', 'briefTitle': 'Umbilical Cord Clamping: What Are the Benefits', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Poliambulanza Istituto Ospedaliero'}, 'officialTitle': 'Delayed Umbilical Cord Clamping in Elective Caesarean Section: What Are the Benefits', 'orgStudyIdInfo': {'id': '3176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Newborns will be subjected to umbilical cord immediate clamping', 'interventionNames': ['Procedure: Immediate umbilical cord clamping']}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Newborns will be subjected to umbilical cord delayed clamping', 'interventionNames': ['Procedure: Delayed umbilical cord clamping']}], 'interventions': [{'name': 'Delayed umbilical cord clamping', 'type': 'PROCEDURE', 'description': 'Umbilical cord will be clamped after 1 min after the birth of the newborn', 'armGroupLabels': ['Study Group']}, {'name': 'Immediate umbilical cord clamping', 'type': 'PROCEDURE', 'description': 'Umbilical cord will be clamped immediately after the birth of the newborn', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25124', 'city': 'Brescia', 'country': 'Italy', 'facility': "Department of mother and child's Health Poliambulanza Foundation", 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Giuseppe De Bernardo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poliambulanza Foundation'}, {'name': 'Maurizio Giordano, B.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Naples Federico II, School of Medicine'}, {'name': 'Laura Linetti, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poliambulanza Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Poliambulanza Istituto Ospedaliero', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe De Bernando', 'investigatorAffiliation': 'Fondazione Poliambulanza Istituto Ospedaliero'}}}}