Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery

Summary

Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother.

Conditions

• Transient Tachypnea of the Newborn

Interventions

OTHER

Physiological based cord clamping

see Arm Description

OTHER

Differed cord clamping

see Arm Description

Sponsors & Collaborators

• The Belgian Kids Fund

  collaborator UNKNOWN

• Fonds IRIS-Recherche

  collaborator UNKNOWN

• Ars Statistica

  collaborator UNKNOWN

• Queen Fabiola Children's University Hospital

  lead OTHER

Principal Investigators

• Anna AMORUSO · HUDERF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

37 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-21

Primary Completion

2024-08-31

Completion

2024-09-30

Countries

• Belgium

Study Locations