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

Helse Møre og Romsdal HF

Status: Completed

Conditions: Cesarean Section; Infant Conditions

Treatments: Procedure: Delayed umbilical cord clamping; Procedure: Extrauterine placental transfusion and physiology-based umbilical cord clamping; Procedure: Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping

Study type: Observational

Funder types: Other

Identifiers

NCT05461950

399101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 263 patients

Sex: Female

Ages: 32 to 42 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

263 participants in 3 patient groups

Self-breathing infants

Description:

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

Treatment:

Procedure: Extrauterine placental transfusion and physiology-based umbilical cord clamping

Infants with respiratory support

Description:

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

Treatment:

Procedure: Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping

Historical control group

Description:

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)

Treatment:

Procedure: Delayed umbilical cord clamping