Placental Transfusion Methods and Stem Cells

Study Overview
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Brief Summary
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To measure the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells levels, and placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping in newborns at different gestational weeks.

Detailed Description
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Umbilical cord blood is a rich source of stem cells. Placental transfusion is the transfer of the placental blood to the baby until the cord clamped during the birth. Placental transfusion can be accomplished by delayed cord clamping or umbilical cord milking. One group will receive 2 minutes of delayed cord clamping, the second group will receive umbilical cord milking and the third group will receive immediate cord clamping. Following the cord clamping, the blood samples will be taken from the placental site of the umbilical cord to measure the stem cells from all subjects and placental residual volume will be measured. Delivery room conditions, hospitalization (if needed), short-term outcome during hospitalization, prematurity related morbidities (if baby is preterm) will be recorded.

Official Title
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The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell

Conditions
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Placental Transfusion, Stem Cells

Intervention / Treatment
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* Procedure: Delayed cord clamping
* Procedure: Umbilical cord milking
* Procedure: Immediate cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born at 24 weeks to 42 weeks infants Exclusion Criteria: Without parental consent, known congenital anomalies

Ages Eligible for Study
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Maximum Age: 3 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed cord clamping<br>Delayed cord clamping | Procedure: Delayed cord clamping<br>* Delayed cord clamping will occur for up to 2 minutes.<br>|
| Active Comparator: Umbilical cord milking<br>Umbilical cord clamping | Procedure: Umbilical cord milking<br>* Umbilical cord milking will occur milking of the 30 cm of the cord from placental site to baby, at a speed of 5 cm/second, 3 times in preterm newborns, 4 times in term newborns.<br>|
| Active Comparator: Immediate cord clamping<br>Immediate cord clamping | Procedure: Immediate cord clamping<br>* Immediate cord clamping will occur in 20 seconds after birth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The levels of stem cells | Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells | 18-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Placental residual volume | The placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping | 18-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell, newborn, endothelial progenitor cell, CD34+ hematopoietic stem cell, delayed cord clamping, umbilical cord milking, immediate cord clamping