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

NCT02187874 | Unknown DMC

• 1 other identifier: PR(AMI)18/2014
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Neonatal mortality

  up to 27 days after birth.

Other Outcomes (5)

• APGAR score

  10 minutes after delivery

• Umbilical cord blood pH

  0-15 minutes after delivery

• Neonatal intubation

  0-30 minutes after delivery

Study Arms (2)

early umbilical cord occlusion

ACTIVE COMPARATOR

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.

Procedure: early umbilical cord occlusion; Drug: Oxytocin

delayed umbilical cord occlusion

EXPERIMENTAL

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.

Procedure: delayed umbilical cord occlusion; Drug: Oxytocin

Interventions

delayed umbilical cord occlusion PROCEDURE

delayed umbilical cord occlusion

early umbilical cord occlusion PROCEDURE

early umbilical cord occlusion

Oxytocin DRUG

delayed umbilical cord occlusion; early umbilical cord occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari de la Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Melchor Carbonell Socias, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Angela Gregoraci, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Maria Goya Canino, MD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

• Maria Angeles Linde, MD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

Central Study Contacts

Melchor Carbonell, MD

CONTACT

0034626470597; xormd11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

ES (1)