Placental Transfusion Methods and Stem Cells

Not Applicable

• Conditions: Placental Transfusion; Stem Cells
• Interventions: Procedure: Umbilical cord milking; Procedure: Immediate cord clamping; Procedure: Delayed cord clamping

• Registration Number: NCT03983902
• Lead Sponsor: Ankara University

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14
• Study Start: 2019-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Born at 24 weeks to 42 weeks infants

Exclusion Criteria

Without parental consent, known congenital anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord milking	Umbilical cord milking	Umbilical cord clamping
Immediate cord clamping	Immediate cord clamping	Immediate cord clamping
Delayed cord clamping	Delayed cord clamping	Delayed cord clamping

Primary Outcome Measures

Name	Time	Method
The levels of stem cells	18-months	Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells

Secondary Outcome Measures

Name	Time	Method
Placental residual volume	18-months	The placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping