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

Postpartum Haemorrhage Clinical Trial

— CODE-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187874
• Other study ID #: PR(AMI)18/2014
• Secondary ID: PR(AMI)18/2014
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: April 23, 2016
• Start date: July 2014

Study information

• Verified date: April 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Melchor Carbonell, MD
• Phone: 0034626470597
• Email: xormd11[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Delayed Umbilical Cord Clamping Benefits
• Hemorrhage
• Intraventricular Haemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• delayed umbilical cord occlusion

• early umbilical cord occlusion

Drug:
• Oxytocin

Locations

Country	Name	City	State
Spain	Hospital Universitari de la Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	APGAR score		10 minutes after delivery	No
Other	Umbilical cord blood pH		0-15 minutes after delivery	No
Other	Neonatal intubation		0-30 minutes after delivery	No
Other	Incidence of intensive reanimation of the newborn	Use of vasoactive drugs.	0-30 minutes after delivery	No
Other	Incidence of adverse events during hospital stay of the newborn.		for the duration of hospital stay, an expected average of 2 month.	Yes
Primary	Number of red blood cell transfusions to the newborn		for the duration of hospital stay, an expected average of 2 months.	No
Primary	Intraventricular Haemorrhage incidence		from delivery, for the duration of hospital stay, an expected average of 2 months.	No
Primary	Maternal postpartum haemorrhage incidence		within 24 hours after birth	Yes
Primary	Volume of neonatal red blood cell transfusions		for the duration of hospital stay, an expected average of 2 months.	No
Secondary	Neonatal mortality	early ( 0 to 6 days after birth); late ( 7 to 27 days after birth)	up to 27 days after birth.	Yes