Placental Transfusion Methods and Stem Cells

NCT ID: NCT03983902

Last Updated: 2019-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-06-30

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.

Conditions

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Placental Transfusion Stem Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Delayed cord clamping

Delayed cord clamping

Group Type ACTIVE_COMPARATOR

Delayed cord clamping

Intervention Type PROCEDURE

Delayed cord clamping will occur for up to 2 minutes.

Umbilical cord milking

Umbilical cord clamping

Group Type ACTIVE_COMPARATOR

Umbilical cord milking

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Immediate cord clamping

Intervention Type PROCEDURE

Immediate cord clamping will occur in 20 seconds after birth.

Interventions

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Delayed cord clamping

Delayed cord clamping will occur for up to 2 minutes.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Immediate cord clamping

Immediate cord clamping will occur in 20 seconds after birth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Born at 24 weeks to 42 weeks infants

Exclusion Criteria

Without parental consent, known congenital anomalies
Maximum Eligible Age

3 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Emel Okulu,MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emel Okulu, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Central Contacts

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Emel Okulu, MD

Role: CONTACT

+90-312-595000 ext. 6599

Saadet Arsan, MD

Role: CONTACT

+90-312-595000 ext. 6324

Other Identifiers

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Ankara University-03

Identifier Type: -

Identifier Source: org_study_id

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