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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-2
SponsorAlexandria University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • intact umbilical milking

    Procedure/Surgery

    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.

  • cut umbilical milking

    Procedure/Surgery

    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

  • Delayed cord clamping

    Procedure/Surgery

    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 groups

160 Participants
are divided into 4 treatment groups
Group A: The procedure of intact umbilical cord milking (I-UCM)Experimental treatment 1 intervention
Group B: The procedure of Cut-umbilical cord milking(C-UCM):Experimental treatment 1 intervention
Group C: The procedure of Delayed Cord Clamping (DCC):Experimental treatment 1 intervention
Group D: Control group:No intervention 0 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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