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

NCT05461950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 263

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

  • Cesarean Section
  • Infant Conditions

Interventions

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)

PROCEDURE

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)

PROCEDURE

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.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Helse Møre og Romsdal HF

    lead OTHER_GOV

Principal Investigators

  • Beate H Eriksen, MD/PhD · Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology

Eligibility

Min Age
32 Weeks
Max Age
42 Weeks
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461950 on ClinicalTrials.gov