Placental TransfusionNCT03983902
Placental Transfusion Methods and Stem Cells
A study testing Delayed cord clamping, Umbilical cord milking and Immediate cord clamping in people with Placental Transfusion and Stem Cells, run by Ankara University.
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. Read more about this study
- Who is it for?
- Ages Up to 3 minutes
- Conditions the study is for
- Placental Transfusion, Stem Cells
- What is being tested?
- Delayed cord clamping, Umbilical cord milking and Immediate cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at 24 weeks to 42 weeks infants
Who cannot join
- Without parental consent, known congenital anomalies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell
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.
Read the 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.
- Conditions
- Placental Transfusion, Stem Cells
- Being tested
- Delayed cord clamping, Umbilical cord milking, Immediate cord clamping
- Keywords
- stem cell, newborn, endothelial progenitor cell, CD34+ hematopoietic stem cell, delayed cord clamping, umbilical cord milking, immediate cord clamping
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
Delayed cord clamping will occur for up to 2 minutes.
Umbilical cord milkingProcedure or surgery
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 clampingProcedure or surgery
Immediate cord clamping will occur in 20 seconds after birth.
| Study group | Role | What they receive |
|---|---|---|
| Delayed cord clamping | Active comparator | Delayed cord clamping Receives: Procedure: Delayed cord clamping |
| Umbilical cord milking | Active comparator | Umbilical cord clamping Receives: Procedure: Umbilical cord milking |
| Immediate cord clamping | Active comparator | Immediate cord clamping Receives: Procedure: Immediate cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of stem cells
Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells
Measured: 18-months
Secondary outcomes (1)
Placental residual volume
The placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping
Measured: 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Okulu,MD, Ankara University
- Investigators
- Emel Okulu, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983902
- Sponsor's protocol ID
- Ankara University-03
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell
- ClinicalTrials.gov ID
- NCT03983902
- Acronym / sponsor ID
- Ankara University-03
- Conditions
- Placental Transfusion, Stem Cells
- Keywords
- stem cell, newborn, endothelial progenitor cell, CD34+ hematopoietic stem cell, delayed cord clamping, umbilical cord milking, immediate cord clamping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Delayed cord clamping | Active comparator | Procedure: Delayed cord clampingDelayed cord clamping |
| Umbilical cord milking | Active comparator | Procedure: Umbilical cord milkingUmbilical cord clamping |
| Immediate cord clamping | Active comparator | Procedure: Immediate cord clampingImmediate cord clamping |
Who may qualify
- Ages
- Up to 3 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born at 24 weeks to 42 weeks infants
Key exclusion criteria (1 listed)
- Without parental consent, known congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed cord clampingDelayed cord clamping will occur for up to 2 minutes. | Procedure or surgery | Delayed cord clamping |
| Umbilical cord milkingUmbilical 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. | Procedure or surgery | Umbilical cord milking |
| Immediate cord clampingImmediate cord clamping will occur in 20 seconds after birth. | Procedure or surgery | Immediate cord clamping |
Primary outcome
The levels of stem cells
Time frame: 18-months
Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells
1 secondary outcome
Placental residual volume
Time frame: 18-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Placental Transfusion
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
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Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality
Recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
Preterm, Infant Death
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Not yet recruiting
MoDi Twin Placental Imaging
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel Okulu, MD principal investigator
Ankara University
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping, Umbilical cord milking and Immediate cord clamping in people with Placental Transfusion and Stem Cells, run by Ankara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emel Okulu, MD (+90-312-595000 ext. 6599, emelokulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of stem cells (time frame: 18-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.