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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
Date last updated
28/11/2023

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
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.
Trial website
https://clinicaltrials.gov/study/NCT00686946
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00686946