The National Register of Antipsychotic Medication in Pregnancy (NRAMP) (NRAMP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The National Register of Antipsychotic Medication in Pregnancy (NRAMP)|
- Participant interviews [ Time Frame: Antenatal - 6-8 wkly; Postnatal - quarterly for 12 months ] [ Designated as safety issue: No ]Interviews to gather demographic, social, medical, psychiatric, medication and obstetric history
- Psychopathology measures for the mother [ Time Frame: Antenatal and up to 12 months postnatally ] [ Designated as safety issue: No ]PANSS (Positive and Negative Syndrome Scale) Questionnaire EPDS (Edinburgh Postnatal Depression Scale)Questionnaire
- Developmental Milestone measures for the baby [ Time Frame: Birth to 12 months of age ] [ Designated as safety issue: No ]BDMQ (Baby Developmental Milestones Questionnaire)
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Participants take their antipsychotic medication as prescribed by their clinical treating teams.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00686946
|Contact: Prof Jayashri Kulkarni, MBBS,FRANZCPemail@example.com|
|Contact: Ms Heather Gilbert, RN Div firstname.lastname@example.org|
|Monash Alfred Pyschiatry Research Centre, Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP 61-3-9076-6564 email@example.com|
|Contact: Ms Heather Gilbert, RN Div 1 61-3-9076-6591 firstname.lastname@example.org|
|Principal Investigator: Prof Jayashri Kulkarni, MBBS,FRANZCP|
|Principal Investigator:||Prof Jayashri Kulkarni, MBBS,FRANZCP||Monash Alfred Psychiatry Research Centre (MAPrc)|