Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
- Conditions
- Cesarean SectionInfant Conditions
- Interventions
- Procedure: Extrauterine placental transfusion and physiology-based umbilical cord clampingProcedure: Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clampingProcedure: Delayed umbilical cord clamping
- Registration Number
- NCT05461950
- Lead Sponsor
- Helse Møre og Romsdal HF
- 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.
- Detailed Description
Standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. If the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 263
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Self-breathing infants Extrauterine placental transfusion and physiology-based umbilical cord clamping 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 Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping 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 Delayed umbilical cord clamping 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)
- Primary Outcome Measures
Name Time Method Intervention fidelity (cohort 2) First 10 minutes after delivery 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.
Intervention fidelity (cohort 1) First 10 minutes after delivery 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.
- Secondary Outcome Measures
Name Time Method Respiratory support (cohort 2) First 10-15 minutes after birth Type of respiratory support applied. Alternatives are: CPAP (Continuous Positive Airway Pressure) or PPV (Positive Pressure Ventilation) Registered on a special data collection sheet by the attending neonatal team or midwife
Apgar score At 5 minutes after birth (cohort 1+2) Composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Heart rate (cohort 1+2) First 10 -15 minutes after birth Infant's heart rate after birth measured by a dry-electrode ECG (NeoBeat). Registered on a special data collection sheet by a timekeeper or attending midwife. Data are transferred wirelessly from the NeoBeat device to the Liveborn App (installed on a designated tablet) for storage and further analysis.
Apgar score (cohort 1+2) At 10 minutes after birth Composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Residual placenta volume (cohort 1+2) Within 10-15 minutes after birth Drained and weighed residual blood volume from placenta and umbilical cord after cord clamping (measured in grams, converted to milliliters by a ratio of 1.05:1). Registered by the attending midwife or assistant nurse
Delivery of placenta (cohort 1+2) At 1 minute (+/- 10 seconds) after birth Time from birth to delivery of the placenta (measured in minutes ans seconds), registered on checklist by a time-keeper in the operating room
Dry-electrode ECG attached (cohort 1+2) Within 10 seconds after birth Time from birth to dry-electrode ECG (NeoBeat) is attached to the infant's chest or abdomen (measured in seconds). Registered on a checklist by a time-keeper in the operating room.
First cry or breathing effort (cohort 1+2) Within 10 minutes after birth Time from birth to infant's first cry or attempt of spontaneous breathing (measured in minutes and seconds). Assessed by attending midwife or pediatric registrar. Registered on a checklist by a time-keeper in the operating room.
Umbilical cord blood samples (cohort 1+2) Within 40-60 seconds after birth Time from birth to sampling for umbilical cord blood gas analysis (arterial and venous) completed (measured in seconds). Registered on a checklist by a time-keeper in the operating room.
Duration of respiratory support (cohort 2) First 10-15 minutes after birth Duration of respiratory support (CPAP or PPV), measured in minutes and seconds. Registered on a special data collection sheet by the attending neonatal team or midwife
Stabilisation (cohort 2) Within 10-20 minutes after birth Time from birth to stabilisation achieved (regular breathing, heartrate (HR) \>100, Saturation (SpO2) \>85%, inspired oxygen fraction (FiO2) \<40%. Measured in minutes and seconds. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Cord clamping time (cohort 1+2) Within 10 minutes after birth Time from birth to umbilical cord clamping (measured in minutes and seconds), registered on a special data collection sheet by the attending midwife
Skin-to-skin-contact (cohort 1+2) Within 2 hours after birth Time from birth to continuous skin-to-skin contact between infant and mother (or other parent), measured in minutes. Registered on a checklist by the attending midwife or neonatal nurse
Trial Locations
- Locations (1)
Møre and Romsdal Hospital Trust
🇳🇴Ålesund, Møre And Romsdal, Norway