Placental Transfusion Methods and Stem Cells

Stem Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03983902
• Other study ID #: Ankara University-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2019
• Source: Ankara University
• Contact: Emel Okulu, MD
• Phone: +90-312-595000
• Email: emelokulu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Minutes

Eligibility

Inclusion Criteria:

Born at 24 weeks to 42 weeks infants

Exclusion Criteria:

Without parental consent, known congenital anomalies

Related Conditions & MeSH terms

• Placental Transfusion
• Stem Cells

Intervention

Procedure:
• Delayed cord clamping
Delayed cord clamping will occur for up to 2 minutes.
• Umbilical cord milking
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
Immediate cord clamping will occur in 20 seconds after birth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The levels of stem cells	Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells	18-months
Secondary	Placental residual volume	The placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping	18-months