Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000539437
Ethics application status
Approved
Date submitted
17/10/2007
Date registered
22/10/2007
Date last updated
21/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ambulatory Fetal Activity Monitoring predicts clinical outcome
Scientific title
Fetal movements detected by an Ambulatory Fetal Activity Monitor will predict clinical outcome
Secondary ID [1] 288812 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal movements 2472 0
Condition category
Condition code
Other 2573 2573 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Monitoring of fetal movements using an Ambulatory Fetal Activity Monitor, which is an accelerometer, like an advanced pedometer. Women will wear these monitors for several days, so that we can record the baby's movements,
Intervention code [1] 2202 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3491 0
Compromised fetus
Timepoint [1] 3491 0
within a few days of birth
Secondary outcome [1] 5827 0
(Exploratory analysis) Predictive values of a range of fetal movement cut-off values
Timepoint [1] 5827 0
within a few days of birth

Eligibility
Key inclusion criteria
Women with a live, singleton pregnancy at >32 weeks' gestation
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fetus with major nervous system or musculoskeletal disorders likely to affect motor activity

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
2/07/2007
Date of last participant enrolment
Anticipated
Actual
20/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
780
Accrual to date
Final
780
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 464 0
4029
Recruitment postcode(s) [2] 465 0
3053
Recruitment postcode(s) [3] 466 0
4101

Funding & Sponsors
Funding source category [1] 2716 0
Government body
Name [1] 2716 0
National Health and Medical Research Council (NHRMC)
Country [1] 2716 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 2461 0
None
Name [1] 2461 0
N/A
Address [1] 2461 0
N/A
Country [1] 2461 0
Other collaborator category [1] 73 0
Hospital
Name [1] 73 0
Royal Brisbane & Women's Hospital
Address [1] 73 0
Butterfield St, Herston QLD 4029
Country [1] 73 0
Australia
Other collaborator category [2] 74 0
Hospital
Name [2] 74 0
Royal Women's Hospital
Address [2] 74 0
Grattan St, Carlton VIC 3053
Country [2] 74 0
Australia
Other collaborator category [3] 75 0
Hospital
Name [3] 75 0
Mater Mothers' Hospital
Address [3] 75 0
South Brisbane QLD 4101
Country [3] 75 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4636 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 4636 0
Butterfield St
Herston QLD 4029
Ethics committee country [1] 4636 0
Australia
Date submitted for ethics approval [1] 4636 0
Approval date [1] 4636 0
07/06/2005
Ethics approval number [1] 4636 0
2005/036
Ethics committee name [2] 4637 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 4637 0
St Lucia QLD 4072
Ethics committee country [2] 4637 0
Australia
Date submitted for ethics approval [2] 4637 0
Approval date [2] 4637 0
28/06/2005
Ethics approval number [2] 4637 0
200500452

Summary
Brief summary
This study will measure the activity of the unborn baby during pregnancy, looking at the number of times s/he moves and how simple or complex the movements are. We expect that the unborn baby who is not getting enough nutrition during pregnancy will have fewer movements than other unborn babies. Once we have this information, we will be able to use it in the future to possibly prevent poor outcomes in those babies who do need help.
Trial website
Trial related presentations / publications
Boashash B, Khlif M, Ben-Jabeur T, East CE, Colditz PB. Passive Detection of Accelerometer-recorded Fetal Movements using a Time-frequency Signal Processing Approach. Digital Signal Processing. 2014. 25: 134-155.

Mesbah M, Girier T, East C, Khlif M, O’Toole J, Wilson S, Callan S, Dann S, Boashash B, Colditz P. 3-axial accelerometer tilt angle for monitoring fetal movements. J Paed Child Health 2011; 47 (Suppl 1): S75. Abstract P052.
Mesbah M, Khlif MS, East C, Smeathers J, Colditz P, Boashash B. Accelerometer-based fetal movement detection. Conf Proc IEE Eng Med Biol Soc 2011:7877-80.

Khlif MS, Boashash B, Layeghy S, Ben-Jabeur T, Mesbah M, East C, Colditz P. Time-frequency characterization of tri-axial accelerometer data for fetal movement detection. ISSPIT. 2011 IEEE International Symposium on Signal Processing and Information Technology, 2011, Conf Proc 7877-80.
Public notes

Contacts
Principal investigator
Name 28124 0
Prof Christine East
Address 28124 0
Royal Women's Hospital
Parkville VIC
Country 28124 0
Australia
Phone 28124 0
+61 3 8345 3700
Fax 28124 0
Email 28124 0
[email protected]
Contact person for public queries
Name 11281 0
Prof Christine East
Address 11281 0
University of Melbourne (Royal Women's Hospital)
Country 11281 0
Australia
Phone 11281 0
+61 3 8345 3700
Fax 11281 0
Email 11281 0
[email protected]
Contact person for scientific queries
Name 2209 0
Prof Christine East
Address 2209 0
University of Melbourne (Royal Women's Hospital)
Country 2209 0
Australia
Phone 2209 0
+61 3 8345 3700
Fax 2209 0
Email 2209 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.