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

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.

Study Overview

• Status: Unknown
• Conditions: Postpartum Haemorrhage; Intraventricular Haemorrhage; Delayed Umbilical Cord Clamping Benefits
• Intervention / Treatment: Drug: Oxytocin; Procedure: early umbilical cord occlusion; Procedure: delayed umbilical cord occlusion

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari de la Vall d'Hebron
    • Contact: Melchor Carbonell, MD; Phone Number: 0034626470597; Email: xormd11@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Oxytocin; Procedure: early umbilical cord occlusion
Experimental: 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.	Drug: Oxytocin; Procedure: delayed umbilical cord occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of red blood cell transfusions to the newborn	for the duration of hospital stay, an expected average of 2 months.
Intraventricular Haemorrhage incidence	from delivery, for the duration of hospital stay, an expected average of 2 months.
Maternal postpartum haemorrhage incidence	within 24 hours after birth
Volume of neonatal red blood cell transfusions	for the duration of hospital stay, an expected average of 2 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal mortality	early ( 0 to 6 days after birth); late ( 7 to 27 days after birth)	up to 27 days after birth.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR score		10 minutes after delivery
Umbilical cord blood pH		0-15 minutes after delivery
Neonatal intubation		0-30 minutes after delivery
Incidence of intensive reanimation of the newborn	Use of vasoactive drugs.	0-30 minutes after delivery
Incidence of adverse events during hospital stay of the newborn.		for the duration of hospital stay, an expected average of 2 month.

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: Melchor Carbonell Socias, MD, Hospital Vall d'Hebron; Principal Investigator: Angela Gregoraci, MD, Hospital Vall d'Hebron; Study Director: Maria Goya Canino, MD, Hospital Vall d'Hebron; Study Director: Maria Angeles Linde, MD, Hospital Vall d'Hebron

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 23, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: PR(AMI)18/2014 (Other Identifier: Hospital Universitari Vall d'Hebron Research Institute)