Trial Review

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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.