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

January 15, 2026 updated by: Marwa Mohamed Farag, Alexandria University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 0325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.
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
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
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
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.
No Intervention: Control group:
patients will not receive any of the methods of placental transfusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on admission (In first day after birth),as well as, at end of first , second and third weeks of lives

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

March 28, 2026

Study Completion (Estimated)

April 28, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0107951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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