The National Register of Antipsychotic Medication in Pregnancy (NRAMP) (NRAMP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2016 by The Alfred
Sponsor:
The Alfred
Collaborators:
Janssen-Cilag Ltd.
AstraZeneca
Hospira, Inc.
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
ClinicalTrials.gov Identifier:
NCT00686946
First received: May 28, 2008
Last updated: January 21, 2016
Last verified: January 2016
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Purpose
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.
| Condition |
|---|
|
Pregnancy Mental Disorders |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The National Register of Antipsychotic Medication in Pregnancy (NRAMP) |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Mental Disorders
U.S. FDA Resources
Further study details as provided by The Alfred:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 500 |
| 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) |
| Groups/Cohorts |
|---|
|
NRAMP
Participants take their antipsychotic medication as prescribed by their clinical treating teams.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women from across Australia who are taking, or have taken, antipsychotic medication during pregnancy
Criteria
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
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686946
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686946
Contacts
| Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP | 61-3-9076-6564 | jayashri.kulkarni@med.monash.edu.au | |
| Contact: Ms Heather Gilbert, RN Div 1 | 61-3-9076-6591 | heather.gilbert@monash.edu |
Locations
| Australia, Victoria | |
| Monash Alfred Pyschiatry Research Centre, Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP 61-3-9076-6564 jayashri.kulkarni@med.monash.edu.au | |
| Contact: Ms Heather Gilbert, RN Div 1 61-3-9076-6591 heather.gilbert@monash.edu | |
| Principal Investigator: Prof Jayashri Kulkarni, MBBS,FRANZCP | |
Sponsors and Collaborators
The Alfred
Janssen-Cilag Ltd.
AstraZeneca
Hospira, Inc.
Investigators
| Principal Investigator: | Prof Jayashri Kulkarni, MBBS,FRANZCP | Monash Alfred Psychiatry Research Centre (MAPrc) |
More Information
| Responsible Party: | Jayashri Kulkarni, Professor, Chief Investigator, The Alfred |
| ClinicalTrials.gov Identifier: | NCT00686946 History of Changes |
| Other Study ID Numbers: | 114/04 |
| Study First Received: | May 28, 2008 |
| Last Updated: | January 21, 2016 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by The Alfred:
|
Severe mental illness Antipsychotic medications Pregnancy Evidence-based guidelines Maternal and infant health and wellbeing |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |
ClinicalTrials.gov processed this record on September 29, 2016