Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000462583
Ethics application status
Not yet submitted
Date submitted
1/11/2006
Date registered
3/11/2006
Date last updated
3/11/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Episodic and Procedural Memory Consolidation during Sleep: Can Memory Impairment during Pregnancy be attributed to Sleep Disturbance?
Scientific title
Observation of change in memory and neuropsychological function: Can Memory Impairment during Pregnancy be attributed to Sleep Disturbance?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory Impairment during Pregnancy 1437 0
Condition category
Condition code
Reproductive Health and Childbirth 1534 1534 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of change in memory and neuropsychological function in the first and third trimesters of pregnancy. The pregnancy group will include females aged 18-40 within the first (6-12 weeks) and third (28-40 weeks) trimester of pregnancy. Both the intervention group and the control group will be assessed at two points in time with a three hour neuropsychological test battery. The intervention group will be tested once during the first trimester (6-12 weeks) of pregnancy, and once during the third trimester (28-40 weeks) of pregnancy.
Intervention code [1] 1426 0
Behaviour
Comparator / control treatment
Control group will be non-pregnant females matched for age and education.The control group (not pregnant women) will be tested on two occasions, approximately three months apart.
Control group

Outcomes
Primary outcome [1] 2117 0
Memory performance in the first and third trimester of pregnancy.
Timepoint [1] 2117 0
Memory performance will be measured at one point in time in the first trimester and at one point in time in the third trimester, with a three hour neuropsychological battery.
Secondary outcome [1] 3660 0
Change in Sleep pattern in the first and third trimester of pregnancy.
Timepoint [1] 3660 0
Sleep architecture will be measured at one point in time in the first trimester and at one point in time in the third trimester, with a polysomnography study.

Eligibility
Key inclusion criteria
Pregnant groupInclusion: Women will need to be recruited whilst still in the first trimester (<12 weeks) of pregnancy. English-speaking.Women will be tested on two occasions, within the first trimester and third trimester.
Non-pregnant women Inclusion:not pregnant, english speaking.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant group Exclusion:Abnormal PregnancyPre-existing medical, psychological, psychiatric or sleep disorder, Non-english speaking.
Non-pregnant group Exclusion - Pre-existing medical, psychological, psychiatric or sleep disorder, Non-english speaking.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1672 0
Charities/Societies/Foundations
Name [1] 1672 0
Austin Hospital Medical Research Foundation
Country [1] 1672 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Austin Hospital Medical Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 1475 0
University
Name [1] 1475 0
Latrobe University Bundoora, VIC, 3083.
Address [1] 1475 0
Country [1] 1475 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3117 0
Austin Health
Ethics committee address [1] 3117 0
Ethics committee country [1] 3117 0
Australia
Date submitted for ethics approval [1] 3117 0
Approval date [1] 3117 0
Ethics approval number [1] 3117 0
Ethics committee name [2] 3118 0
Mercy Health
Ethics committee address [2] 3118 0
Ethics committee country [2] 3118 0
Australia
Date submitted for ethics approval [2] 3118 0
Approval date [2] 3118 0
Ethics approval number [2] 3118 0
Ethics committee name [3] 3119 0
La Trobe University Bundoora
Ethics committee address [3] 3119 0
Ethics committee country [3] 3119 0
Australia
Date submitted for ethics approval [3] 3119 0
Approval date [3] 3119 0
Ethics approval number [3] 3119 0

Summary
Brief summary
Women in the first and third trimesters of pregnancy will be compared to a matched control group of non-pregnant women. Outcome measures will be measures of memory and sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27360 0
Address 27360 0
Country 27360 0
Phone 27360 0
Fax 27360 0
Email 27360 0
Contact person for public queries
Name 10615 0
Maree Barnes
Address 10615 0
Institute for Breathing and Sleep
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 10615 0
Australia
Phone 10615 0
+61 3 94965756
Fax 10615 0
Email 10615 0
[email protected]
Contact person for scientific queries
Name 1543 0
Danielle Wilson
Address 1543 0
Institute for Breathing and Sleep
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 1543 0
Australia
Phone 1543 0
+61 3 94963688
Fax 1543 0
Email 1543 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.