Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.

Summary

Early cord clamping after delivery has been common practice for many decades as part of the active management of the third stage of labour. However in recent years, several studies have shown that delayed cord clamping may offer important benefits to the newborn. The data gathered indicate that delayed cord clamping may be particularly useful in premature babies, between 26 and 32 weeks of gestational age, reducing the need for blood transfusion and the incidence of intraventricular haemorrhage.

However it is argued that the described potential benefits of delayed cord clamping could be negated by the increased risk of polycythaemia and jaundice in the newborn, as well as by potential interference with the postpartum haemorrhage management, initial care and reanimation of the premature newborn, and the possibility of cord blood donation. These factors, together with as the lack of homogeneity among existing studies regarding the delayed cord clamping technique create the need, in our opinion, for further research, to establish the proper place of this measure.

Our hypothesis is that delayed cord clamping in the premature newborn significatively reduces the need for blood transfusions and intraventricular haemorrhage, compared with usual early cord clamping.

Secondary outcomes:

* To define the impact of delayed cord clamping on neonatal assessment parameters after delivery: APGAR score, cord pH, need for mechanical ventilation or reanimation.
* Neonatal mortality and morbidity
* Effect of the procedure on the incidence and severity of maternal postpartum haemorrhage
* To study the correlation between Iron metabolism and reticulocitary haemoglobin levels in cord and infant blood.

Conditions

• Delayed Umbilical Cord Clamping Benefits
• Postpartum Haemorrhage
• Intraventricular Haemorrhage

Interventions

PROCEDURE

delayed umbilical cord occlusion

PROCEDURE

early umbilical cord occlusion

DRUG

Oxytocin

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Melchor Carbonell Socias, MD · Hospital Vall d'Hebron

• Angela Gregoraci, MD · Hospital Vall d'Hebron

• Maria Goya Canino, MD · Hospital Vall d'Hebron

• Maria Angeles Linde, MD · Hospital Vall d'Hebron

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2017-07-31

Countries

• Spain

Study Locations