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

Alexandria University

Status: Enrolling

Conditions: Premature; Placental Transfusion

Treatments: Procedure: cut umbilical milking; Procedure: intact umbilical milking; Procedure: Delayed cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT06812507

0107951

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 1 to 2 minutes old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Procedure: intact umbilical milking

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

Experimental group

Description:

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

Treatment:

Procedure: cut umbilical milking

The procedure of Delayed Cord Clamping (DCC):

Experimental group

Description:

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.

Treatment:

Procedure: Delayed cord clamping

Control group:

No Intervention group

Description:

patients will not receive any of the methods of placental transfusions