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

Cesarean Section Clinical Trial

— INTACT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461950
• Other study ID #: 399101
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 32 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Infant Conditions

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Norway	Møre and Romsdal Hospital Trust	Ålesund	Møre And Romsdal

Sponsors (2)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-cesarean infection (all cohorts)	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	Within14 days after surgery (cesarean section)
Other	Abnormal blood loss (all cohorts)	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	45 minutes from incision time
Other	Pre-operative maternal Hemoglobin	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	Within 48 hours before cesarean section
Other	Post-operative maternal Hemoglobin	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	Within 24 hours after cesarean section
Other	Low Apgar score (all cohorts)	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	At 5 minutes after birth
Other	Infant hypothermia (all cohorts)	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	Within 2 hours after birth
Other	Admittance to Neonatal Intensive Care Unit (NICU) (all cohorts)	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	Within 24 hours after birth
Other	Days in NICU (all cohorts)	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	Maximum 2 months
Primary	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
Primary	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	Dry-electrode ECG attached (cohort 1+2)	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.	Within 10 seconds after birth
Secondary	First cry or breathing effort (cohort 1+2)	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.	Within 10 minutes after birth
Secondary	Heart rate (cohort 1+2)	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.	First 10 -15 minutes after birth
Secondary	Umbilical cord blood samples (cohort 1+2)	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.	Within 40-60 seconds after birth
Secondary	Apgar score (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 by the attending midwife or pediatric registrar, registered on a special data collection sheet by a timekeeper in the operating room	At 1 minute after birth
Secondary	Delivery of placenta (cohort 1+2)	Time from birth to delivery of the placenta (measured in minutes ans seconds), registered on checklist by a time-keeper in the operating room	At 1 minute (+/- 10 seconds) after birth
Secondary	Respiratory support (cohort 2)	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	First 10-15 minutes after birth
Secondary	Duration of respiratory support (cohort 2)	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	First 10-15 minutes after birth
Secondary	Apgar score	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	At 5 minutes after birth (cohort 1+2)
Secondary	Stabilisation (cohort 2)	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	Within 10-20 minutes after birth
Secondary	Cord clamping time (cohort 1+2)	Time from birth to umbilical cord clamping (measured in minutes and seconds), registered on a special data collection sheet by the attending midwife	Within 10 minutes after birth
Secondary	Apgar score (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	At 10 minutes after birth
Secondary	Skin-to-skin-contact (cohort 1+2)	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	Within 2 hours after birth
Secondary	Residual placenta volume (cohort 1+2)	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	Within 10-15 minutes after birth