Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
INTACT
Feasibility-testing of Extra-uterine Placental Transfusion to Facilitate Intact-cord Stabilisation and Physiology-based Cord Clamping for Term and Preterm Infants Delivered by Acute or Planned Caesarean Section
1 other identifier
observational
263
1 country
1
Brief Summary
This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedJune 4, 2024
June 1, 2024
1.5 years
July 13, 2022
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intervention fidelity (cohort 1)
Extra-uterine placental transfusion + physiology-based cord clamping applied (for vigorous infants), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
First 10 minutes after delivery
Intervention fidelity (cohort 2)
Extra-uterine placental transfusion + intact-cord stabilisation + physiology-based cord clamping applied (for infants needing any respiratory support), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
First 10 minutes after delivery
Secondary Outcomes (14)
Dry-electrode ECG attached (cohort 1+2)
Within 10 seconds after birth
First cry or breathing effort (cohort 1+2)
Within 10 minutes after birth
Heart rate (cohort 1+2)
First 10 -15 minutes after birth
Umbilical cord blood samples (cohort 1+2)
Within 40-60 seconds after birth
Apgar score (cohort 1+2)
At 1 minute after birth
- +9 more secondary outcomes
Other Outcomes (8)
Post-cesarean infection (all cohorts)
Within14 days after surgery (cesarean section)
Abnormal blood loss (all cohorts)
45 minutes from incision time
Pre-operative maternal Hemoglobin
Within 48 hours before cesarean section
- +5 more other outcomes
Study Arms (3)
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
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
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)
Interventions
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)
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)
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
Women planning to give birth at Clinic Ålesund are candidates for enrolment in this clinical study. Pregnant women will be invited to participate when called for second trimester routine ultrasound scan. They will be asked for preliminary consent in the event of intrapartum or planned cesarean section and fullfilment of inclusion cirteria. Women having ultrasound scans done elsewhere, who are later referred to Clinic Ålesund, may be invited to participate after admission, but will not be approached for consent if delivery is imminent. Both parents (if applicable) must consent on behalf of their infant
You may qualify if:
- live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
- 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).
You may not qualify if:
- twins, triplets
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Møre and Romsdal Hospital Trust
Ålesund, Møre and Romsdal, 6026, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beate H Eriksen, MD/PhD
Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 18, 2022
Study Start
October 3, 2022
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
June 4, 2024
Record last verified: 2024-06