The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion

Summary

Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of years. Based on published data, numerous neonatal benefits have been suggested such as increased hemoglobin and ferritin levels both at birth and longer term. Available systematic reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other neonatal outcomes including polycythemia and hyperbilirubinemia.

A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a second objective assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels \>15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly.

In this randomized control study the investigators would like to determine if delayed cord clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring phototherapy) in term infants.

Conditions

• Jaundice Neonatal

Interventions

OTHER

Delayed cord clamping

We have decided to delay cord clamping in the intervention group to 3 minutes and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.

OTHER

Cord milking

If cord milking will be the allocated intervention, the recruiter will supervise the midwife, or obstetrician preforming the procedure, and count out loud the number of times the cord has been milked. During vaginal deliveries midwifes will be asked to maintain the infant at least 10 cm above the uterus until the cord is clamped. In case of caesarian sections the baby will be placed on the mother's laps and swaddled in sterile towels to prevent heat loss.

OTHER

Early cord clamping

We have decided to clamp the cord in the early intervention group at 30 seconds and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.

Sponsors & Collaborators

• Medical University of Warsaw

  collaborator OTHER

• Princess Anna Mazowiecka Hospital, Warsaw, Poland

  lead OTHER

Principal Investigators

• Joanna Seliga-Siwecka, MD Phd · Medical University of Warsaw

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

37 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2016-06-30

Completion

2016-12-31

Countries

• Poland

Study Locations