Clinical trial NCT02187874: Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
Official title: Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delayed Umbilical Cord Clamping Benefits
Postpartum Haemorrhage
Intraventricular Haemorrhage
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Deliveries ( either vaginal or by C-section) between 26 and 32.6 weeks of gestation.
* Patients must be over 18 years old.
* Patient understands and signs informed consent.

Exclusion Criteria:

* Urgent C-section
* gestational age under 22 or over 33 weeks
* Major fetal anomalies (requiring surgery or with a high risk of neonatal death or incapacity)
* Major uterine malformations
* Placenta previa.
* Multiple gestations
* Fetal hydrops
* Severe Iso- Immunization
* HIV-positive mother
* Severe Intrauterine growth restriction ( Reverse atrial Flow in DV)
* Intrauterus Ventricular haemorrhage

Primary outcomes:
measure: Number of red blood cell transfusions to the newborn
timeFrame: for the duration of hospital stay, an expected average of 2 months.
measure: Intraventricular Haemorrhage incidence
timeFrame: from delivery, for the duration of hospital stay, an expected average of 2 months.
measure: Maternal postpartum haemorrhage incidence
timeFrame: within 24 hours after birth
measure: Volume of neonatal red blood cell transfusions
timeFrame: for the duration of hospital stay, an expected average of 2 months.
Secondary outcomes:
measure: Neonatal mortality
timeFrame: up to 27 days after birth.
Other outcomes:
measure: APGAR score
timeFrame: 10 minutes after delivery
measure: Umbilical cord blood pH
timeFrame: 0-15 minutes after delivery
measure: Neonatal intubation
timeFrame: 0-30 minutes after delivery
measure: Incidence of intensive reanimation of the newborn
timeFrame: 0-30 minutes after delivery
measure: Incidence of adverse events during hospital stay of the newborn.
timeFrame: for the duration of hospital stay, an expected average of 2 month.
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron
name: Melchor Carbonell Socias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron
name: Angela Gregoraci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron
name: Maria Goya Canino, MD
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: Maria Angeles Linde, MD
role: STUDY_DIRECTOR
References: