Preterm BirthNCT07385326
Umbilical Cord Clamping Methods and Stem Cell Counts in Preterm Infants
A study testing Immediate Cord Clamping, Delayed Cord Clamping and Umbilical Cord Milking in people with Preterm Birth and Umbilical Cord Clamping, run by Era Tufan Benli at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns. Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Read more about this study
- Who is it for?
- Ages 0 days and olderHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Umbilical Cord Clamping
- What is being tested?
- Immediate Cord Clamping, Delayed Cord Clamping and Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jun 2015
- 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 0 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preterm neonates born between 28+0 and 36+6 weeks of gestation.
- Infants born at a single tertiary referral center.
- Written informed consent obtained from parents prior to delivery.
Who cannot join
- Major fetal congenital anomalies.
- Perinatal asphyxia.
- Requirement for advanced neonatal resuscitation at birth.
- Undetermined gestational age.
- Gestational age less than 28 weeks.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,
Ankara
About this study
Official title: Effect of Umbilical Cord Clamping Method on Peripheral Blood Stem Cell Counts in Preterm Newborns: A Randomized Controlled Trial
This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Peripheral blood samples were collected after birth to assess stem cell concentrations.
The aim of the study was to determine whether physiological cord management strategies could influence early hematologic adaptation in preterm infants. The study was conducted using standard clinical procedures without additional intervention beyond routine care.
Read the detailed description
This prospective randomized study was conducted to investigate the impact of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Eligible preterm infants were randomly allocated to one of the predefined umbilical cord clamping strategies according to the study protocol. All procedures were performed as part of standard obstetric and neonatal care, and no experimental intervention outside routine clinical practice was applied.
Peripheral blood samples were obtained following delivery, and hematopoietic stem cell concentrations were analyzed using standard laboratory methods. The primary outcome was the comparison of stem cell counts between the different cord clamping groups.
The study was initiated and completed in 2015, prior to mandatory prospective clinical trial registration requirements. Ethical approval was obtained from the relevant institutional ethics committee, and informed consent was obtained from parents or legal guardians before participation.
- Conditions
- Preterm Birth, Umbilical Cord Clamping
- Being tested
- Immediate Cord Clamping, Delayed Cord Clamping, Umbilical Cord Milking
- Keywords
- Preterm newborn, Umbilical cord clamping, Hematopoietic stem cells, Peripheral blood, Randomized study
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Cord ClampingProcedure or surgery
Clamping of the umbilical cord within 30 seconds after delivery.
Delayed Cord ClampingProcedure or surgery
Clamping of the umbilical cord 60 seconds after delivery.
Umbilical Cord MilkingProcedure or surgery
Milking of a 20 cm segment of the umbilical cord toward the infant before clamping.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Cord Clamping (ICC) | Experimental | Umbilical cord clamped within 30 seconds after birth. Receives: Procedure: Immediate Cord Clamping |
| Delayed Cord Clamping (DCC) | Experimental | Umbilical cord clamped 60 seconds after birth. Receives: Procedure: Delayed Cord Clamping |
| Umbilical Cord Milking (UCM) | Experimental | Umbilical cord milked toward the infant before clamping. Receives: Procedure: Umbilical Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Hemoglobin Level
Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups.
Measured: Within first 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to three parallel groups based on umbilical cord management method.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Era Tufan Benli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Era Tufan Benli, Dr. Sami Ulus Children's Hospital
- Investigators
- Meryem Ceyhan, Dr., Principal investigator, Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385326
- Sponsor's protocol ID
- SUCCH-UCC-2015
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Cord Clamping Method on Peripheral Blood Stem Cell Counts in Preterm Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07385326
- Acronym / sponsor ID
- SUCCH-UCC-2015
- Conditions
- Preterm Birth, Umbilical Cord Clamping
- Keywords
- Preterm newborn, Umbilical cord clamping, Hematopoietic stem cells, Peripheral blood, Randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Era Tufan BenliUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Feb 2026 (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.
This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Peripheral blood samples were collected after birth to assess stem cell concentrations.
The aim of the study was to determine whether physiological cord management strategies could influence early hematologic adaptation in preterm infants. The study was conducted using standard clinical procedures without additional intervention beyond routine care.
Detailed description
This prospective randomized study was conducted to investigate the impact of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Eligible preterm infants were randomly allocated to one of the predefined umbilical cord clamping strategies according to the study protocol. All procedures were performed as part of standard obstetric and neonatal care, and no experimental intervention outside routine clinical practice was applied.
Peripheral blood samples were obtained following delivery, and hematopoietic stem cell concentrations were analyzed using standard laboratory methods. The primary outcome was the comparison of stem cell counts between the different cord clamping groups.
The study was initiated and completed in 2015, prior to mandatory prospective clinical trial registration requirements. Ethical approval was obtained from the relevant institutional ethics committee, and informed consent was obtained from parents or legal guardians before participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to three parallel groups based on umbilical cord management method.
| Arm | Type | Receives |
|---|---|---|
| Immediate Cord Clamping (ICC) | Experimental | Procedure: Immediate Cord ClampingUmbilical cord clamped within 30 seconds after birth. |
| Delayed Cord Clamping (DCC) | Experimental | Procedure: Delayed Cord ClampingUmbilical cord clamped 60 seconds after birth. |
| Umbilical Cord Milking (UCM) | Experimental | Procedure: Umbilical Cord MilkingUmbilical cord milked toward the infant before clamping. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm neonates born between 28+0 and 36+6 weeks of gestation.
- Infants born at a single tertiary referral center.
- Written informed consent obtained from parents prior to delivery.
Key exclusion criteria (5 listed)
- Major fetal congenital anomalies.
- Perinatal asphyxia.
- Requirement for advanced neonatal resuscitation at birth.
- Undetermined gestational age.
- Gestational age less than 28 weeks.
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 |
|---|---|---|
| Immediate Cord ClampingClamping of the umbilical cord within 30 seconds after delivery. | Procedure or surgery | Immediate Cord Clamping (ICC) |
| Delayed Cord ClampingClamping of the umbilical cord 60 seconds after delivery. | Procedure or surgery | Delayed Cord Clamping (DCC) |
| Umbilical Cord MilkingMilking of a 20 cm segment of the umbilical cord toward the infant before clamping. | Procedure or surgery | Umbilical Cord Milking (UCM) |
Primary outcome
Neonatal Hemoglobin Level
Time frame: Within first 24 hours after birth
Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Meryem Ceyhan, Dr. principal investigator
Department of Gynecology and Obstetrics, Lokman Hekim University, Faculty of Medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Cord Clamping, Delayed Cord Clamping and Umbilical Cord Milking in people with Preterm Birth and Umbilical Cord Clamping, run by Era Tufan Benli at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Hemoglobin Level (time frame: Within first 24 hours after birth). 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 4 Feb 2026.