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

NCT ID: NCT02187874

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

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.

Conditions

Delayed Umbilical Cord Clamping Benefits; Postpartum Haemorrhage; Intraventricular Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

early umbilical cord occlusion

Cord clamping will be performed before 30 seconds after delivery, annoting the exact time of clampage and initiating reanimation and postnatal care procedures as usual. 60 second after delivery of the new born, 10 IU of Oxytocin will be administered intramuscularly.

Group Type: ACTIVE_COMPARATOR

early umbilical cord occlusion

Intervention Type: PROCEDURE

Oxytocin

Intervention Type: DRUG

delayed umbilical cord occlusion

One of the paediatricians will hold the newborn ( in vaginal deliveries between 20-30 cm under the mother, in C-sections between the legs of the mother) until clamping of the umbilical cord is indicated by a second paediatrician who will be controlling the time and overall state of the baby. The baby will be wrapped during this time in a thermal blanket in a flexed lateral decubitus position to minimise stress and heat loss. Time of clamping: after 30 to 60 seconds( preferably 60). If loss of the baby's wellbeing is suspected, the paediatrician will assess the newborn's heart rate , stopping the procedureif this falls under 100ppm, initiating at that moment the necessary reanimation procedures.

60 second after the delivery of the new born 10 IU of oxytocin will be administered intramuscularly.

Group Type: EXPERIMENTAL

delayed umbilical cord occlusion

Intervention Type: PROCEDURE

Oxytocin

Intervention Type: DRUG

Interventions

delayed umbilical cord occlusion

Intervention Type: PROCEDURE

early umbilical cord occlusion

Intervention Type: PROCEDURE

Oxytocin

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melchor Carbonell Socias, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Angela Gregoraci, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Maria Goya Canino, MD

Role: STUDY_DIRECTOR

Hospital Vall d'Hebron

Maria Angeles Linde, MD

Role: STUDY_DIRECTOR

Hospital Vall d'Hebron

Locations

Hospital Universitari de la Vall d'Hebron

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Melchor Carbonell, MD

Role: CONTACT

xormd11@gmail.com

0034626470597

Facility Contacts

Melchor Carbonell, MD

Role: primary

xormd11@gmail.com

0034626470597

Other Identifiers

PR(AMI)18/2014

Identifier Type: OTHER

Identifier Source: secondary_id

PR(AMI)18/2014

Identifier Type: -

Identifier Source: org_study_id