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Effects of Milking the Umbilical Cord on Systemic Blood Flow

S

Sharp HealthCare

Status

Completed

Conditions

Abnormal Vascular Flow

Treatments

Procedure: Umbilical Cord Milking
Procedure: Immediate Cord Clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT01434732
CORDMILK

Details and patient eligibility

About

Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.

Full description

The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.

This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

Enrollment

60 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • infants < 32 weeks gestation

Exclusion criteria

  • obstetrician's refusal to participate
  • multiple gestations (if Di-Mo placentation) surrogate delivery
  • parental desire for cord blood banking
  • major congenital anomalies
  • severe maternal illness
  • placental abruption or previa
  • ruptured uterus at delivery, or hemoperitoneum

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Umbilical Cord Milking
Experimental group
Description:
Umbilical Cord Milking involved milking the umbilical cord at birth.
Treatment:
Procedure: Umbilical Cord Milking
Immediate Cord Clamping
Active Comparator group
Description:
Umbilical cord is clamped soon after birth without any milking of the cord.
Treatment:
Procedure: Immediate Cord Clamping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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