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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00686946




Registration number
NCT00686946
Ethics application status
Date submitted
28/05/2008
Date registered
30/05/2008

Titles & IDs
Public title
The National Register of Antipsychotic Medication in Pregnancy (NRAMP)
Scientific title
The National Register of Antipsychotic Medication in Pregnancy (NRAMP)
Secondary ID [1] 0 0
114/04
Universal Trial Number (UTN)
Trial acronym
NRAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 0 0
Mental Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
NRAMP - Participants take their antipsychotic medication as prescribed by their clinical treating teams.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant interviews
Timepoint [1] 0 0
Antenatal - once per trimester; Postnatal - quarterly for 12 months
Secondary outcome [1] 0 0
Psychopathology measures for the mother
Timepoint [1] 0 0
Antenatal and up to 12 months postnatally
Secondary outcome [2] 0 0
Developmental Milestone measures for the baby
Timepoint [2] 0 0
Birth to 12 months of age

Eligibility
Key inclusion criteria
* Women who take antipsychotic medication during pregnancy
* Women who are pregnant or have had a baby in the last 12 months
* Women who are living in Australia
* Women who are able to provide informed consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who do not take antipsychotic medication during pregnancy
* Women who are not pregnant, or have not had a baby in the last 12 months
* Women who are unable to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Alfred Pyschiatry Research Centre, Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen-Cilag Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AstraZeneca
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Hospira, now a wholly owned subsidiary of Pfizer
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Jayashri Kulkarni, MBBS,FRANZCP
Address 0 0
Monash Alfred Psychiatry Research Centre (MAPrc)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prof Jayashri Kulkarni, MBBS,FRANZCP
Address 0 0
Country 0 0
Phone 0 0
61-3-9076-6564
Fax 0 0
Email 0 0
jayashri.kulkarni@med.monash.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data will be shared, for example, in Case Studies, where personal identification is not compromised, which also allows for an aggregate view of data.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00686946