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RecruitingNCT06812507Updated Jan 16, 2026

Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile

An interventional study of intact umbilical milking and cut umbilical milking in Premature and Placental Transfusion, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 1 Minute to 2 Minutes, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
1 Minute to 2 Minutes
Sex
All
01

Study 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

02

Conditions studied

  • Premature
  • Placental Transfusion
03

Who can participate

Ages eligible
1 Minute to 2 Minutes
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  • Inclusion Criteria:

    1. Premature neonates ≤ 32 weeks gestational age regardless birth weight
    2. patients should be admitted to neonatal intensive care unit in the first day of life of life

Exclusion criteria:

  • Exclusion Criteria:

Patient with any of the following will be excluded:

  1. Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
  2. Evidence of head trauma causing major intracranial hemorrhage.
  3. placental abnormalities like : abruptions, placenta previa or retroplacental hematoma.
  4. Cord accident, or avulsion at the time of delivery.
  5. Refusal to perform the intervention by the obstetrician
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    The procedure of intact umbilical cord milking (I-UCM)

    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.

    Procedure: intact umbilical milking

  • Experimental
    The procedure of Cut-umbilical cord milking(C-UCM):

    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

    Procedure: cut umbilical milking

  • Experimental
    The procedure of Delayed Cord Clamping (DCC):

    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.

    Procedure: Delayed cord clamping

  • No intervention
    Control group:

    patients will not receive any of the methods of placental transfusions

Interventions

  • Procedureintact umbilical milking

    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.

  • Procedurecut umbilical milking

    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

  • ProcedureDelayed cord clamping

    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.

05

What researchers measure

Primary outcomes

  1. Hemoglobin level

    hemoglobin level will be measured in gram/dl

    Time frame: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives

06

Study locations

1 of 1 sites recruiting
  • Marwa Mohamed Farag
    Alexandria, 0325, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — Data will be available upon reasonable request

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06812507
Lead sponsor
Alexandria University
Responsible party
Marwa Mohamed Farag (Assistant professor of Pediatrics, Alexandria University) — Principal investigator
First posted
Feb 6, 2025
Start date
Mar 10, 2025
Primary completion
Mar 28, 2026 (estimated)
Completion
Apr 28, 2026 (estimated)
Last update
Jan 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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