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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)
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Scientific title
The National Register of Antipsychotic Medication in Pregnancy (NRAMP)
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Secondary ID [1]
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114/04
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Universal Trial Number (UTN)
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Trial acronym
NRAMP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pregnancy
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Mental Disorders
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
NRAMP - Participants take their antipsychotic medication as prescribed by their clinical treating teams.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participant interviews
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Assessment method [1]
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Interviews to gather demographic, social, medical, psychiatric, medication and obstetric history
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Timepoint [1]
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Antenatal - once per trimester; Postnatal - quarterly for 12 months
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Secondary outcome [1]
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Psychopathology measures for the mother
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Assessment method [1]
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PANSS (Positive and Negative Syndrome Scale) Questionnaire EPDS (Edinburgh Postnatal Depression Scale)Questionnaire
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Timepoint [1]
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Antenatal and up to 12 months postnatally
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Secondary outcome [2]
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Developmental Milestone measures for the baby
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Assessment method [2]
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ASQ-3 (Ages and Stages Questionnaire, Third Edition)
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Timepoint [2]
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Birth to 12 months of age
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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
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Alfred Pyschiatry Research Centre, Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Janssen-Cilag Ltd.
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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AstraZeneca
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Address [2]
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Country [2]
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0
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Other collaborator category [3]
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Commercial sector/industry
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Name [3]
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Hospira, now a wholly owned subsidiary of Pfizer
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Address [3]
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Country [3]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The National Register of Antipsychotic Medication in Pregnancy (NRAMP)is an observational, nationwide study involving women of child-bearing age who take antipsychotic medication during pregnancy. It follows the pathway of mother and baby during pregnancy and for the first 12 months of the baby's life, in order to develop evidence-based guidelines for the best use and effect of antipsychotic medication during pregnancy, thereby informing clinical treating teams with regard to the management of their patients in this vulnerable population group. The investigators hypothesize that the provision of such evidence-based guidelines will improve the management and outcomes for mother and baby during pregnancy, birth and the postnatal phase, providing a positive impact on maternal and child health and wellbeing for present and future generations.
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Trial website
https://clinicaltrials.gov/study/NCT00686946
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jayashri Kulkarni, MBBS,FRANZCP
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Address
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Monash Alfred Psychiatry Research Centre (MAPrc)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Prof Jayashri Kulkarni, MBBS,FRANZCP
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Address
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Country
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Phone
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61-3-9076-6564
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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