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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12612000071820 |
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Date of registration:
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16/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Aboriginal Cord Delayed Clamping Study: investigating delayed cord clamping versus immediate cord clamping for term newborn Aboriginal infants from remote Aboriginal communities.
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Scientific title:
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Effect of delayed cord clamping on the haemoglobin levels of term newborn Aboriginal infants from remote Aboriginal communities: a pilot randomized controlled trial. |
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Date of first enrolment:
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19/01/2012 |
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Target sample size:
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72 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12612000071820.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr. Melanie Hanson
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Address:
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Paediatric Department, Royal Darwin Hospital
Rocklands Drive, TIWI, NT, 0180
Australia |
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Telephone:
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+61 8 89228888 |
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Email:
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melanie.hanson@menzies.edu.au |
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Affiliation:
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Name:
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Dr. Peter Morris
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Address:
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Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811
Australia |
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Telephone:
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+61 8 89228296 |
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Email:
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peter.morris@menzies.edu.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: pregnant Aboriginal women usually resident in a remote Aboriginal community at 36 to 42 weeks gestation who are expected to give birth by uncomplicated normal vaginal delivery or elective Caesarian section.
Exclusion criteria: pregnancies complicated by maternal hypertension, pre-eclampsia, risk of post-partum haemorrhage, evidence of intra-uterine growth restriction (estimated fetal weight <10th centile) or congenital malformations
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Blood - Anaemia
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Reproductive Health and Childbirth - Childbirth and postnatal care
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Term birth;neonatal health;
Term birth
neonatal health
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Intervention(s)
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Delayed cord clamping until the cord stops pulsating (at least 1 minute and no more than 3 minutes after delivery) with baby held below level of placenta or vaginal introitus. If there are complications that arise with the delivery or the baby is in distress at birth, immediate cord clamping is done to allow for neonatal resuscitation.
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Primary Outcome(s)
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Neonatal haemoglobin measured using capillary blood sampling and analyzed in hospital laboratory using standard methods.[after birth prior to hospital discharge (~3 days of age)]
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Secondary Outcome(s)
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types of treatments received with associated conditions and noted for presence or none and collected from the baby's medical records.[before hospital discharge]
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Apgar Scores of less than 7 to indicate low apgar scores and assessed by their presence or absence and collected fom baby's medical records.[1 and 5 minutes]
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mortality to determine incidence and collected from baby's medical records.[before hospital discharge]
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newborn length of stay assessed by recording total number of hospital days and collected from baby's medical records.[at time of hospital discharge]
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effect on Indigenous Cord Blood Collection Program by measuring the total placental volume after delayed cord clamping and comparing this volume to the amounts collected after immediate cord clamping to detect any significant difference that will affect the program's usual volume collected primarily after immediate cord clamping. These volumes will be recorded in a data collection sheet.[before hospital discharge]
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Morbidity (incidence of respiratory distress, jaundice, polycythemia, seizures, sepsis, necrotizing enterocolitis, neonatal death)
Above conditions will be assessed by their presence or absence during the baby's hospital admission and collected from baby's medical records.[before hospital discharge]
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SCN admission and assessed by admission or none and noted from baby's medical records[before hospital discharge]
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type of feeding assessed by determining if baby was on breastfeeding, bottlefeeding or mixed feeding on discharge and data collected from baby's medical records.[at hospital discharge]
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Source(s) of Monetary Support
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Royal Darwin Hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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