Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
NCT ID: NCT05461950
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
263 participants
OBSERVATIONAL
2022-10-03
2024-03-31
Brief Summary
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Detailed Description
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It has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. Since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. To date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. This may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility.
The objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Self-breathing infants
Vigorous infants with spontaneous onset of respiration within one minute after delivery by cesarean section, receiving extra-uterine placental transfusion and physiology-based cord clamping
Extrauterine placental transfusion and physiology-based umbilical cord clamping
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room, the umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infants is breathing regularly (within 10 minutes after delivery)
Infants with respiratory support
Infants with no or poor spontaneous onset of respiration after delivery by cesarean section, receiving extra-uterine placental transfusion, intact-cord stabilisation (any respiratory support) and physiology-based cord clamping after transfer to resuscitation table
Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room and necessary respiratory support is initiated (CPAP or PPV) by a neonatal team. The umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infant is breathing regularly with or without support (at maximum 10 minutes after delivery)
Historical control group
Infants delivered by cesarean section in a time period when delayed cord clamping after 1-3 minutes was default procedure. Less-than-vigorous infants needing respiratory support or full resuscitation had their umbilical cords cut early (within 30 seconds)
Delayed umbilical cord clamping
Umbilical cord is clamped and cut minimum 60 seconds after delivery to facilitate placental transfusion. Placenta is delivered after cord clamping. Infants needing respiratory support or other stabilisation are transferred to a warmer in the adjacent room where a neonatal team is waiting.
Interventions
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Extrauterine placental transfusion and physiology-based umbilical cord clamping
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room, the umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infants is breathing regularly (within 10 minutes after delivery)
Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room and necessary respiratory support is initiated (CPAP or PPV) by a neonatal team. The umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infant is breathing regularly with or without support (at maximum 10 minutes after delivery)
Delayed umbilical cord clamping
Umbilical cord is clamped and cut minimum 60 seconds after delivery to facilitate placental transfusion. Placenta is delivered after cord clamping. Infants needing respiratory support or other stabilisation are transferred to a warmer in the adjacent room where a neonatal team is waiting.
Eligibility Criteria
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Inclusion Criteria
* delivered by CS in regional anaesthesia
* immediate care may be planned with involved personnel prior to delivery
* informed maternal consent is obtained (parental consent on behalf of the unborn child).
Exclusion Criteria
* significant congenital malformations
* placenta complications with high risk of abnormal maternal blood loss
* severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
* participation in any other clinical study within the last month
* not sufficient time for preparations or collection of maternal/parental consent
* mother does not comprehend Norwegian or English
32 Weeks
42 Weeks
FEMALE
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Helse Møre og Romsdal HF
OTHER_GOV
Responsible Party
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Principal Investigators
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Beate H Eriksen, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology
Locations
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Møre and Romsdal Hospital Trust
Ålesund, Møre and Romsdal, Norway
Countries
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Other Identifiers
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399101
Identifier Type: -
Identifier Source: org_study_id
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