Clinical trial NCT05461950: Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Infant Conditions
Keywords: infant stabilisation
intact umbilical cord
umbilical cord clamping
placental transfusion
cesarean section
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: Norwegian University of Science and Technology
First posted: 2022-07-18
Enrollment: 263
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention fidelity (cohort 1)
timeFrame: First 10 minutes after delivery
measure: Intervention fidelity (cohort 2)
timeFrame: First 10 minutes after delivery
Secondary outcomes:
measure: Dry-electrode ECG attached (cohort 1+2)
timeFrame: Within 10 seconds after birth
measure: First cry or breathing effort (cohort 1+2)
timeFrame: Within 10 minutes after birth
measure: Heart rate (cohort 1+2)
timeFrame: First 10 -15 minutes after birth
measure: Umbilical cord blood samples (cohort 1+2)
timeFrame: Within 40-60 seconds after birth
measure: Apgar score (cohort 1+2)
timeFrame: At 1 minute after birth
measure: Delivery of placenta (cohort 1+2)
timeFrame: At 1 minute (+/- 10 seconds) after birth
measure: Respiratory support (cohort 2)
timeFrame: First 10-15 minutes after birth
measure: Duration of respiratory support (cohort 2)
timeFrame: First 10-15 minutes after birth
measure: Apgar score
timeFrame: At 5 minutes after birth (cohort 1+2)
measure: Stabilisation (cohort 2)
timeFrame: Within 10-20 minutes after birth
measure: Cord clamping time (cohort 1+2)
timeFrame: Within 10 minutes after birth
measure: Apgar score (cohort 1+2)
timeFrame: At 10 minutes after birth
measure: Skin-to-skin-contact (cohort 1+2)
timeFrame: Within 2 hours after birth
measure: Residual placenta volume (cohort 1+2)
timeFrame: Within 10-15 minutes after birth
Other outcomes:
measure: Post-cesarean infection (all cohorts)
timeFrame: Within14 days after surgery (cesarean section)
measure: Abnormal blood loss (all cohorts)
timeFrame: 45 minutes from incision time
measure: Pre-operative maternal Hemoglobin
timeFrame: Within 48 hours before cesarean section
measure: Post-operative maternal Hemoglobin
timeFrame: Within 24 hours after cesarean section
measure: Low Apgar score (all cohorts)
timeFrame: At 5 minutes after birth
measure: Infant hypothermia (all cohorts)
timeFrame: Within 2 hours after birth
measure: Admittance to Neonatal Intensive Care Unit (NICU) (all cohorts)
timeFrame: Within 24 hours after birth
measure: Days in NICU (all cohorts)
timeFrame: Maximum 2 months
Locations:
city: Ålesund
country: Norway
facility: Møre and Romsdal Hospital Trust
state: Møre And Romsdal
Study officials:
affiliation: Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology
name: Beate H Eriksen, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: