Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine whether the umbilical cord milking in preterm infants born by cesarian section less than 34 weeks is more effective than delayed cord clamping to obtain higher levels of hemoglobin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedApril 28, 2016
April 1, 2016
1.5 years
June 6, 2014
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemoglobin
g/dl
1 hour and 24 hours at born
Secondary Outcomes (9)
Apgar Score
1 and 5 minutes
Arterial pressure
2, 6, 12, 24, 36 and 48 hours of life
Orine volume
24 and 48 hours of life
Use of vasopresors drugs
24 hours of life
Number of concentrate hematies transfusion
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
- +4 more secondary outcomes
Study Arms (2)
Umbilical cord milking
EXPERIMENTALOnce the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
Delayed cord clamping
ACTIVE COMPARATOROnce the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
Interventions
Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
Eligibility Criteria
You may qualify if:
- Preterm infants less than 34 weeks' gestation born by cesarean section
You may not qualify if:
- Inability to obtain informed consent from the mother state
- Monochorionic-monoamniotic twin gestation
- Placenta abruption
- Uterine rupture
- Transplacental cesarean
- Hydrops fetalis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Monica Domingo-Puiggros, MD
Corporacio Sanitaria Parc Tauli
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
June 6, 2014
First Posted
July 11, 2014
Study Start
July 1, 2014
Primary Completion
January 1, 2016
Study Completion
March 1, 2016
Last Updated
April 28, 2016
Record last verified: 2016-04