The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1637 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2020-09-30

Brief Summary

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To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.

Detailed Description

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Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by delaying the clamping of the umbilical cord by 60 seconds or more. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all very preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm, before it becomes even more widely used.

The Australian Placental Transfusion Study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. These participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. The main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Early cord clamping (Control Arm)

Immediate cord clamping (\< 10 seconds after birth). The cord is clamped 6 cm from the umbilicus within ten seconds of delivery of the baby.

Group Type NO_INTERVENTION

No interventions assigned to this group

Deferred cord clamping

Deferred cord clamping. Investigator/Research personnel holds the baby as low as possible below the level of the introitus or placenta for 60 seconds and not to exceed 80 seconds, then clamps the cord about 6 cm from the umbilicus.

Group Type EXPERIMENTAL

Deferred cord clamping

Intervention Type PROCEDURE

Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)

Interventions

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Deferred cord clamping

Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Women who have a reasonable chance of delivering less than 30 weeks of gestation. Informed consent has been received from the parent or guardian.

Exclusion Criteria

No indication or contraindication to placental transfusion, in the view of mother or baby.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William T Mordi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Vermont Medical Centre

Burlington, Vermont, United States

Site Status

Canberra Hospital

Canberra, Australian Capital Territory, Australia

Site Status