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

Primary Purpose

Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
delayed umbilical cord occlusion
early umbilical cord occlusion
Oxytocin
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Umbilical Cord Clamping Benefits

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Universitari de la Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

early umbilical cord occlusion

delayed umbilical cord occlusion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of red blood cell transfusions to the newborn
Intraventricular Haemorrhage incidence
Maternal postpartum haemorrhage incidence
Volume of neonatal red blood cell transfusions

Secondary Outcome Measures

Neonatal mortality
early ( 0 to 6 days after birth) late ( 7 to 27 days after birth)

Full Information

First Posted
July 9, 2014
Last Updated
April 23, 2016
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02187874
Brief Title
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
Acronym
CODE-P
Official Title
Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Umbilical Cord Clamping Benefits, Postpartum Haemorrhage, Intraventricular Haemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early umbilical cord occlusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
delayed umbilical cord occlusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
delayed umbilical cord occlusion
Intervention Type
Procedure
Intervention Name(s)
early umbilical cord occlusion
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Primary Outcome Measure Information:
Title
Number of red blood cell transfusions to the newborn
Time Frame
for the duration of hospital stay, an expected average of 2 months.
Title
Intraventricular Haemorrhage incidence
Time Frame
from delivery, for the duration of hospital stay, an expected average of 2 months.
Title
Maternal postpartum haemorrhage incidence
Time Frame
within 24 hours after birth
Title
Volume of neonatal red blood cell transfusions
Time Frame
for the duration of hospital stay, an expected average of 2 months.
Secondary Outcome Measure Information:
Title
Neonatal mortality
Description
early ( 0 to 6 days after birth) late ( 7 to 27 days after birth)
Time Frame
up to 27 days after birth.
Other Pre-specified Outcome Measures:
Title
APGAR score
Time Frame
10 minutes after delivery
Title
Umbilical cord blood pH
Time Frame
0-15 minutes after delivery
Title
Neonatal intubation
Time Frame
0-30 minutes after delivery
Title
Incidence of intensive reanimation of the newborn
Description
Use of vasoactive drugs.
Time Frame
0-30 minutes after delivery
Title
Incidence of adverse events during hospital stay of the newborn.
Time Frame
for the duration of hospital stay, an expected average of 2 month.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melchor Carbonell, MD
Phone
0034626470597
Email
xormd11@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melchor Carbonell Socias, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Gregoraci, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Goya Canino, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Angeles Linde, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitari de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melchor Carbonell, MD
Phone
0034626470597
Email
xormd11@gmail.com

12. IPD Sharing Statement

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

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