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Completed

NCT Number: NCT05461950

Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections

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.

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Key information

Conditions

Cesarean Section Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetofetal Transfusion Hematologic Diseases Hemic and Lymphatic Diseases Infant Conditions Infant, Newborn, Diseases

Age range

32 week–42 week

Sex eligibility

Female

Study type

Observational

Primary location

Møre and Romsdal Hospital Trust

Ålesund, Møre and Romsdal, 6026, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Extrauterine placental transfusion and physiology-based umbilical cord clamping

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Intervention fidelity (cohort 1)

    Time frame: 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.

  2. Intervention fidelity (cohort 2)

    Time frame: 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.

Secondary outcomes

  1. Dry-electrode ECG attached (cohort 1+2)

    Time frame: 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.

  2. First cry or breathing effort (cohort 1+2)

    Time frame: 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.

  3. Heart rate (cohort 1+2)

    Time frame: 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.

  4. Umbilical cord blood samples (cohort 1+2)

    Time frame: 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.

  5. Apgar score (cohort 1+2)

    Time frame: At 1 minute 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 by the attending midwife or pediatric registrar, registered on a special data collection sheet by a timekeeper in the operating room

  6. Delivery of placenta (cohort 1+2)

    Time frame: 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

  7. Respiratory support (cohort 2)

    Time frame: 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

  8. Duration of respiratory support (cohort 2)

    Time frame: 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

  9. Apgar score

    Time frame: 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

  10. Stabilisation (cohort 2)

    Time frame: 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

  11. Cord clamping time (cohort 1+2)

    Time frame: 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

  12. Apgar score (cohort 1+2)

    Time frame: 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

  13. Skin-to-skin-contact (cohort 1+2)

    Time frame: 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

  14. Residual placenta volume (cohort 1+2)

    Time frame: 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

Other outcomes

  1. Post-cesarean infection (all cohorts)

    Time frame: Within14 days after surgery (cesarean section)

    Prevalence of maternal post-operative wound infection needing antibiotic therapy. Registered in a dedicated paper form in the patient's record by the attending obstetrician

  2. Abnormal blood loss (all cohorts)

    Time frame: 45 minutes from incision time

    Prevalence of abnormal maternal blood-loss during surgery and wound closure (more than 1000 ml). Estimated by staff by visual inspection and count of blood-soaked compresses. Registered in the patient's record by the attending obstetrician

  3. Pre-operative maternal Hemoglobin

    Time frame: Within 48 hours before cesarean section

    Maternal Hemoglobin value from a venous blood sample taken before cesarean section, measured in grams per 100 ml. Registered on a checklist and in the patient's record by the midwife

  4. Post-operative maternal Hemoglobin

    Time frame: Within 24 hours after cesarean section

    Maternal Hemoglobin value from a venous blood sample taken after cesarean section, measured in grams per 100 ml. Registered on a checklist and in the patient's record by the midwife

  5. Low Apgar score (all cohorts)

    Time frame: At 5 minutes after birth

    Prevalence of infant Apgar score less than 7 (mild asphyxia), composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (subscale range from 0-2). Assessed and registered on a special data collection sheet and in the patient's record by the attending midwife or neonatal team

  6. Infant hypothermia (all cohorts)

    Time frame: Within 2 hours after birth

    Prevalence of infant rectal temperature less than 36.5 degrees celsius, measured by a thermometer and registered on a special data collection form and in the patient's record by the attending midwife or neonatal team

  7. Admittance to Neonatal Intensive Care Unit (NICU) (all cohorts)

    Time frame: Within 24 hours after birth

    Indication for infant's admittance to neonatal intensive care unit after birth. Assessed by the attending pediatric registrar or neonatologist. Registered in a special data collection sheet and in the patient's record

  8. Days in NICU (all cohorts)

    Time frame: Maximum 2 months

    Infant's length of stay i neonatal intensive care unit, measured in days. Registered on a checklist and in the patient's record by the neonatal team

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Acronym: INTACT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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