Back to resultsUmbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
Primary Purpose
Premature Infant, Umbilical Cord, Milking
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Umbilical cord milking
Delayed cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Premature Infant focused on measuring Hemodynamics, Premature Infant, Umbilical cord, Milking, Delayed clamping
Eligibility Criteria
Inclusion Criteria:
- Preterm infants less than 34 weeks' gestation born by cesarean section
Exclusion Criteria:
- Inability to obtain informed consent from the mother state
- Monochorionic-monoamniotic twin gestation
- Placenta abruption
- Uterine rupture
- Transplacental cesarean
- Hydrops fetalis
Sites / Locations
- Corporacio Sanitaria Parc Tauli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Umbilical cord milking
Delayed cord clamping
Arm Description
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.
Outcomes
Primary Outcome Measures
Haemoglobin
g/dl
Secondary Outcome Measures
Apgar Score
Basic score to mesure the newborn status. From 0 to 10.
Arterial pressure
Mean of systolic and dyastolic arterial pressure in mm Hg
Orine volume
Total volume of orine at 24 and 48 hours of life. Total ml.
Use of vasopresors drugs
To use or not to use the vasopresors drugs during the first 24 hours of life
Number of concentrate hematies transfusion
Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Intraventricular hemorrhage
Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile
Bronchopulmonary dysplasia
Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)
Total intensive care unit stay
Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Hematocrit
In percentage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02187510
Brief Title
Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Umbilical Cord, Milking, Delayed Clamping
Keywords
Hemodynamics, Premature Infant, Umbilical cord, Milking, Delayed clamping
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed cord clamping
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord milking
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed cord clamping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Haemoglobin
Description
g/dl
Time Frame
1 hour and 24 hours at born
Secondary Outcome Measure Information:
Title
Apgar Score
Description
Basic score to mesure the newborn status. From 0 to 10.
Time Frame
1 and 5 minutes
Title
Arterial pressure
Description
Mean of systolic and dyastolic arterial pressure in mm Hg
Time Frame
2, 6, 12, 24, 36 and 48 hours of life
Title
Orine volume
Description
Total volume of orine at 24 and 48 hours of life. Total ml.
Time Frame
24 and 48 hours of life
Title
Use of vasopresors drugs
Description
To use or not to use the vasopresors drugs during the first 24 hours of life
Time Frame
24 hours of life
Title
Number of concentrate hematies transfusion
Description
Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Time Frame
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Title
Intraventricular hemorrhage
Description
Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile
Time Frame
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Title
Bronchopulmonary dysplasia
Description
Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)
Time Frame
participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Title
Total intensive care unit stay
Description
Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
Time Frame
Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
Title
Hematocrit
Description
In percentage
Time Frame
1 hour and 24 hours at born
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm infants less than 34 weeks' gestation born by cesarean section
Exclusion Criteria:
Inability to obtain informed consent from the mother state
Monochorionic-monoamniotic twin gestation
Placenta abruption
Uterine rupture
Transplacental cesarean
Hydrops fetalis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Domingo-Puiggros, MD
Organizational Affiliation
Corporacio Sanitaria Parc Tauli
Official's Role
Study Director
Facility Information:
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
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Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section
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