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

NCT06812507 | Recruiting DMC

• 1 other identifier: 0107951
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Premature; Placental Transfusion

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  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

Study Arms (4)

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.

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

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.

Procedure: Delayed cord clamping

Control group:

NO INTERVENTION

patients will not receive any of the methods of placental transfusions

Interventions

intact umbilical milking PROCEDURE

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.

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

cut umbilical milking PROCEDURE

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

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

Delayed cord clamping PROCEDURE

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.

The procedure of Delayed Cord Clamping (DCC):

Eligibility Criteria

• Age: 1 Minute - 2 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth; Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Pediatrics

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: March 10, 2025
• Primary Completion: March 28, 2026
• Study Completion: April 28, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)