Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000071820
Ethics application status
Approved
Date submitted
10/01/2012
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Aboriginal Cord Delayed Clamping Study: investigating delayed cord clamping versus immediate cord clamping for term newborn Aboriginal infants from remote Aboriginal communities.
Scientific title
Effect of delayed cord clamping on the haemoglobin levels of term newborn Aboriginal infants from remote Aboriginal communities: a pilot randomized controlled trial.
Secondary ID [1] 273472 0
TBA
Universal Trial Number (UTN)
U1111-1126-0867
Trial acronym
ACDC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Term birth 279262 0
neonatal health 285570 0
Condition category
Condition code
Blood 279460 279460 0 0
Anaemia
Reproductive Health and Childbirth 285768 285768 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 283789 0
Other interventions
Comparator / control treatment
Immediate cord clamping soon after birth (within 1 minute after delivery).
Control group
Active

Outcomes
Primary outcome [1] 286018 0
Neonatal haemoglobin measured using capillary blood sampling and analyzed in hospital laboratory using standard methods.
Timepoint [1] 286018 0
after birth prior to hospital discharge (~3 days of age)
Secondary outcome [1] 294993 0
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.
Timepoint [1] 294993 0
before hospital discharge
Secondary outcome [2] 294994 0
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.
Timepoint [2] 294994 0
1 and 5 minutes
Secondary outcome [3] 294995 0
SCN admission and assessed by admission or none and noted from baby's medical records
Timepoint [3] 294995 0
before hospital discharge
Secondary outcome [4] 294996 0
types of treatments received with associated conditions and noted for presence or none and collected from the baby's medical records.
Timepoint [4] 294996 0
before hospital discharge
Secondary outcome [5] 294997 0
newborn length of stay assessed by recording total number of hospital days and collected from baby's medical records.
Timepoint [5] 294997 0
at time of hospital discharge
Secondary outcome [6] 294998 0
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.
Timepoint [6] 294998 0
at hospital discharge
Secondary outcome [7] 294999 0
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.
Timepoint [7] 294999 0
before hospital discharge
Secondary outcome [8] 295000 0
mortality to determine incidence and collected from baby's medical records.
Timepoint [8] 295000 0
before hospital discharge

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 will be consented. Randomization will be done by by investigators or midwifery team present during the second stage of labour. Allocation concealment will be achieved by the use of sequentially numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization sequence will be prepared by an independent statistician at NHMRC Clinical TrialsCentre. The randomization code will be stored securely by the NHMRC Clinical Trials Centre. The allocation sequence will be concealed from all investigators, staff and participants throughout the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284264 0
Hospital
Name [1] 284264 0
Royal Darwin Hospital
Country [1] 284264 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies School of Health Research
Address
Rocklands Drive, Tiwi, NT, 0810
Country
Australia
Secondary sponsor category [1] 283216 0
Hospital
Name [1] 283216 0
Royal Darwin Hospital
Address [1] 283216 0
Rocklands Drive, Tiwi, NT, 0810
Country [1] 283216 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286224 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 286224 0
Ethics committee country [1] 286224 0
Australia
Date submitted for ethics approval [1] 286224 0
16/11/2011
Approval date [1] 286224 0
11/01/2012
Ethics approval number [1] 286224 0
2011-1657

Summary
Brief summary
Anaemia is prevalent among Aboriginal infants under 12 months old. Delayed cord clamping is a simple way to provide extra blood to the newborn baby. Strong evidence from randomized controlled trials has shown its benefits for neonatal health and reducing anaemia in early infancy. The beneficial effects on Aboriginal infants and beyond the first 6 months of life are still unknown. It is clinically important to determine if this simple intervention at birth will impact greatly the health of remote Aboriginal infants with high risk of anaemia due to poor access to nutrition later in infancy.
This RCT will enroll 72 Aboriginal pregnant women from remote aboriginal communities who will give birth at 36-42 weeks gestation by uncomplicated NVD or CS. They will be randomly assigned to either receive the interventional delayed cord clamping until the cord stops pulsating or up to 3 minutes with baby held below level of placenta or vaginal introitus or the standard care immediate cord clamping soon after birth under 1 minute. The primary research question is whether haemoglobin level at discharge is greatest in babies after delayed cord clamping.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33442 0
Address 33442 0
Country 33442 0
Phone 33442 0
Fax 33442 0
Email 33442 0
Contact person for public queries
Name 16689 0
Dr. Melanie Hanson
Address 16689 0
Paediatric Department, Royal Darwin Hospital
Rocklands Drive, TIWI, NT, 0180
Country 16689 0
Australia
Phone 16689 0
+61 8 89228888
Fax 16689 0
+61 8 89275187
Email 16689 0
[email protected]
Contact person for scientific queries
Name 7617 0
Dr. Peter Morris
Address 7617 0
Menzies School of Health Research
PO Box 41096
CASUARINA NT 0811
Country 7617 0
Australia
Phone 7617 0
+61 8 89228296
Fax 7617 0
+61 8 89275187
Email 7617 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.