Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000643370
Ethics application status
Approved
Date submitted
5/11/2008
Date registered
17/12/2008
Date last updated
16/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent transfusions for women with red cell alloimmunisation: A randomised trial
Scientific title
Fetal Middle Cerebral Artery (MCA) Doppler to time second and subsequent transfusions for women with red cell alloimmunisation: A randomised trial
Secondary ID [1] 290554 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Red cell alloimmunisation in pregnancy 3927 0
Condition category
Condition code
Reproductive Health and Childbirth 4123 4123 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Middle Cerebral Artery (MCA) Doppler ultrasound
The Middle Cerebral Artery (MCA) Doppler ultrasound will be used to determine the timing of second and subsequent fetal blood transfusions where one intrauterine fetal transfusion has been performed for anaemia due to red cell alloimmunisation.
This is an ultrasound examination where the speed of blood flow in the fetal brain is assessed, and is performed during pregnancy. It is used to identify if the fetus is at risk of anaemia. The ultrasound examination takes approximately 10 minutes to perform. Because of the nature of red cell alloimmunisation it is often necessary to perform these ultrasound examinations several times over the course of a pregnancy.
Women who participate in the study will be followed to four months after birth.
Intervention code [1] 3645 0
Diagnosis / Prognosis
Comparator / control treatment
Standard nomogram

The standard nomogram is a chart which takes into account the gestation of the pregnancy, the amount of blood transfused to the fetus, the haemoglobin concentration before and after the transfusion. It then charts the expected fall in haemoglobin and using this information it is possible to time the second transfusion.

Because of the nature of red cell alloimmunisation, several blood transfusions for the fetus are often required during the course of the pregnancy.
At present the standard nomogram is used each time a woman undergoes an intra-uterine fetal blood sample. The precise number of transfusions varies for each pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 5013 0
Cord blood haemoglobin.
Timepoint [1] 5013 0
Measured in cord blood taken at time of birth.
Secondary outcome [1] 8460 0
Procedure related complications necessitating emergency delivery.
These complications are documented in the woman's case notes and will be obtained from review of the case notes.
Timepoint [1] 8460 0
Pregnancy.
Information about these complications will be collected from the case notes at the end of pregnancy.
Secondary outcome [2] 8461 0
Other adverse infant outcomes related to alloimmunisation.
These complications are documented in the woman's case notes and will be obtained from review of the case notes.
Timepoint [2] 8461 0
Birth
Information about these complications will be collected from the case notes at the end of pregnancy and after the woman and infant have been discharged.
Secondary outcome [3] 8462 0
Adverse outcomes for the woman.
Information about these complications will be collected from the case notes at the end of pregnancy.
Timepoint [3] 8462 0
Pregnancy and birth
Information about these complications will be collected from the case notes at the end of pregnancy and after the woman and infant have been discarged.
Secondary outcome [4] 329399 0
Adverse outcomes for the infant related to alloimmunisation. This includes the presence of anaemia (both at the time of transfusion and at the time of the baby's birth) as measured on cord blood from the baby. This information is collected routinely from babies who require in-utero blood transfusion and will be extracted from information contained in the woman and infant's case notes.
Timepoint [4] 329399 0
Birth - anaemia will be determined by cord blood taken at the time of birth.

Eligibility
Key inclusion criteria
Pregnant women whose fetus has anaemia secondary to red cell alloimmunisation (due to any red cell antibody alone or in combination) as indicated by the need to have performed a single intra-uterine fetal blood transfusion
Minimum age
18 Years
Maximum age
48 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women whose fetus has anaemia secondary to any other cause; known fetal chromosomal anomalies

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central telephone randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2009
Actual
19/10/2009
Date of last participant enrolment
Anticipated
Actual
1/10/2013
Date of last data collection
Anticipated
Actual
30/07/2016
Sample size
Target
564
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment outside Australia
Country [1] 1350 0
Canada
State/province [1] 1350 0
Ontario; Quebec, British Columbia
Country [2] 8393 0
United Kingdom
State/province [2] 8393 0
Country [3] 8394 0
Ireland
State/province [3] 8394 0
Country [4] 8395 0
Argentina
State/province [4] 8395 0
Country [5] 8396 0
New Zealand
State/province [5] 8396 0

Funding & Sponsors
Funding source category [1] 4109 0
University
Name [1] 4109 0
The University of Adelaide
Country [1] 4109 0
Australia
Funding source category [2] 294990 0
Government body
Name [2] 294990 0
NHMRC
Country [2] 294990 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Discipline of Obstetrics and Gynaecology
72 King William Road
North Adelaide 5006
South Australia
Country
Australia
Secondary sponsor category [1] 3757 0
None
Name [1] 3757 0
Address [1] 3757 0
Country [1] 3757 0
Secondary sponsor category [2] 3877 0
None
Name [2] 3877 0
Address [2] 3877 0
Country [2] 3877 0
Other collaborator category [1] 463 0
Individual
Name [1] 463 0
Professor Greg Ryan
Address [1] 463 0
Mt Sinai Hospital
700 University Avenue
Toronto Ontario M5G 2X4
Country [1] 463 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6183 0
Mt Sinai Hospital
Ethics committee address [1] 6183 0
700 University Avenue
Toronto Ontario M5G 2X4
Ethics committee country [1] 6183 0
Canada
Date submitted for ethics approval [1] 6183 0
Approval date [1] 6183 0
31/08/2009
Ethics approval number [1] 6183 0
Ethics committee name [2] 296343 0
Women's and Children's Health Network HREC
Ethics committee address [2] 296343 0
72 King William St,
North Adelaide 5006 South Australia
Ethics committee country [2] 296343 0
Australia
Date submitted for ethics approval [2] 296343 0
15/12/2008
Approval date [2] 296343 0
27/07/2009
Ethics approval number [2] 296343 0
REC 2148/2/12

Summary
Brief summary
The aim of this study is to assess in the fetus where one intrauterine fetal transfusion has been performed for anaemia due to red cell alloimmunisation, whether fetal middle cerebral artery (MCA) Doppler can be safely used to determine the timing of second and subsequent fetal blood transfusions, without increasing the risk of adverse fetal and neonatal health outcomes.

Red cell alloimmunisation is estimated to affect 0.1 to 0.6% of all live births. Treatment of the resultant fetal anaemia with intrauterine fetal blood transfusion has been associated with survival rates in excess of 90%. However, intrauterine fetal blood sampling and transfusion is an invasive procedure, with recognised complications, which may result in the need for early birth, and rarely mortality. More recently, reports have emerged utilising Doppler ultrasound to measure the fetal middle cerebral artery (MCA) peak systolic velocity (PSV) to determine the presence of fetal anaemia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29096 0
Prof Jodie Dodd
Address 29096 0
The University of Adelaide
72 King William St,
North Adelaide 5006 South Australia
Country 29096 0
Australia
Phone 29096 0
+61881617619
Fax 29096 0
Email 29096 0
[email protected]
Contact person for public queries
Name 12253 0
Jodie Dodd
Address 12253 0
72 King William Road
North Adelaide 5006
South Australia
Country 12253 0
Australia
Phone 12253 0
+61 8 8161 7619
Fax 12253 0
+61 8 8161 7652
Email 12253 0
[email protected]
Contact person for scientific queries
Name 3181 0
Jodie Dodd
Address 3181 0
72 King William Road
North Adelaide 5006
South Australia
Country 3181 0
Australia
Phone 3181 0
+61 8 8161 7619
Fax 3181 0
+61 8 8161 7652
Email 3181 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
SourceTitleYear of PublicationDOI
Dimensions AI89: Exploring the diagnostic and prognostic potential of amniotic fluid exosomes in twin-twin transfusion syndrome (TTTS)2017https://doi.org/10.1016/j.ajog.2016.11.977
N.B. These documents automatically identified may not have been verified by the study sponsor.