Placental Transfusion Methods and Stem Cells
The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell
1 other identifier
interventional
96
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
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 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 14, 2019
June 1, 2019
1.5 years
June 10, 2019
June 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The levels of stem cells
Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells
18-months
Secondary Outcomes (1)
Placental residual volume
18-months
Study Arms (3)
Delayed cord clamping
ACTIVE COMPARATORDelayed cord clamping
Umbilical cord milking
ACTIVE COMPARATORUmbilical cord clamping
Immediate cord clamping
ACTIVE COMPARATORImmediate cord clamping
Interventions
Delayed cord clamping will occur for up to 2 minutes.
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.
Immediate cord clamping will occur in 20 seconds after birth.
Eligibility Criteria
You may qualify if:
- Born at 24 weeks to 42 weeks infants
You may not qualify if:
- Without parental consent, known congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emel Okulu, MD
Ankara University
Central Study Contacts
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
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 12, 2019
Study Start
July 1, 2019
Primary Completion
December 31, 2020
Study Completion
June 30, 2021
Last Updated
June 14, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share