PrematureNCT06812507
Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile
A study testing intact umbilical milking, cut umbilical milking and Delayed cord clamping in people with Premature and Placental Transfusion, run by Alexandria University at 1 site in Egypt.
Trial summary
The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life Read more about this study
- Who is it for?
- Ages 1 minute to 2 minutesHealthy volunteers can take part
- Conditions the study is for
- Premature, Placental Transfusion
- What is being tested?
- intact umbilical milking, cut umbilical milking and Delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2025to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 minute to 2 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature neonates ≤ 32 weeks gestational age regardless birth weight
- patients should be admitted to neonatal intensive care unit in the first day of life of life
Who cannot join
- Patient with any of the following will be excluded:
- Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
- Evidence of head trauma causing major intracranial hemorrhage.
- placental abnormalities like : abruptions, placenta previa or retroplacental hematoma.
- Cord accident, or avulsion at the time of delivery.
- Refusal to perform the intervention by the obstetrician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Marwa Mohamed Farag
Alexandria, 0325
Marwa M Farag, 01288681788, d.marwa.farag@gmail.com
About this study
Official title: Evaluation of Placental Transfusion Techniques in of Prematurity Related Complications and Hematological Profile
The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life
- Conditions
- Premature, Placental Transfusion
- Being tested
- intact umbilical milking, cut umbilical milking, Delayed cord clamping
- Medical subject headings
- Premature Birth, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intact umbilical milkingProcedure or surgery
Umbilical cord milking will be performed by holding the newborn at or
∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team.
cut umbilical milkingProcedure or surgery
Another technique, used more often in Asia, involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM
Delayed cord clampingProcedure or surgery
Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60-second before clamping the cord.
| Study group | Role | What they receive |
|---|---|---|
| The procedure of intact umbilical cord milking (I-UCM) | Experimental | Umbilical cord milking will be performed by holding the newborn at or
∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team. Receives: Procedure: intact umbilical milking |
| The procedure of Cut-umbilical cord milking(C-UCM): | Experimental | Another technique, used more often in Asia, involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM Receives: Procedure: cut umbilical milking |
| The procedure of Delayed Cord Clamping (DCC): | Experimental | Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60-second before clamping the cord. Receives: Procedure: Delayed cord clamping |
| Control group: | No intervention | patients will not receive any of the methods of placental transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
hemoglobin level will be measured in gram/dl
Measured: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start10 Mar 2025
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812507
- Sponsor's protocol ID
- 0107951
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Placental Transfusion Techniques in of Prematurity Related Complications and Hematological Profile
- ClinicalTrials.gov ID
- NCT06812507
- Acronym / sponsor ID
- 0107951
- Conditions
- Premature, Placental Transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The procedure of intact umbilical cord milking (I-UCM) | Experimental | Procedure: intact umbilical milkingUmbilical cord milking will be performed by holding the newborn at or ∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team. |
| The procedure of Cut-umbilical cord milking(C-UCM): | Experimental | Procedure: cut umbilical milkingAnother technique, used more often in Asia, involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM |
| The procedure of Delayed Cord Clamping (DCC): | Experimental | Procedure: Delayed cord clampingInfants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60-second before clamping the cord. |
| Control group: | No intervention | –patients will not receive any of the methods of placental transfusions |
Who may qualify
- Ages
- 1 minute to 2 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
Key exclusion criteria (6 listed)
- Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
- Evidence of head trauma causing major intracranial hemorrhage.
- placental abnormalities like : abruptions, placenta previa or retroplacental hematoma.
- Cord accident, or avulsion at the time of delivery.
- Refusal to perform the intervention by the obstetrician
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 |
|---|---|---|
| intact umbilical milkingUmbilical cord milking will be performed by holding the newborn at or ∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team. | Procedure or surgery | The procedure of intact umbilical cord milking (I-UCM) |
| cut umbilical milkingAnother technique, used more often in Asia, involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM | Procedure or surgery | The procedure of Cut-umbilical cord milking(C-UCM): |
| Delayed cord clampingInfants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60-second before clamping the cord. | Procedure or surgery | The procedure of Delayed Cord Clamping (DCC): |
Primary outcome
Hemoglobin level
Time frame: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives
hemoglobin level will be measured in gram/dl
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intact umbilical milking, cut umbilical milking and Delayed cord clamping in people with Premature and Placental Transfusion, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Jan 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives). 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 16 Jan 2026.