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

NCT ID: NCT06812507

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-04-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intact umbilical milking

Intervention Type: 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 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

Group Type: EXPERIMENTAL

cut umbilical milking

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Delayed cord clamping

Intervention Type: 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.

Control group:

patients will not receive any of the methods of placental transfusions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: PROCEDURE

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

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 2 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mohamed Farag

Assistant professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marwa Mohamed Farag

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Marwa M Farag

Role: primary

d.marwa.farag@gmail.com

01288681788

Other Identifiers

0107951

Identifier Type: -

Identifier Source: org_study_id