The National Register of Antipsychotic Medication in Pregnancy (NRAMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by The Alfred
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
ClinicalTrials.gov Identifier:
NCT00686946
First received: May 28, 2008
Last updated: June 23, 2014
Last verified: June 2014
  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
Antipsychotic Medications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The National Register of Antipsychotic Medication in Pregnancy (NRAMP)

Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Participant interviews [ Time Frame: Antenatal - 6 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: 300
Study Start Date: January 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Contacts
Contact: Prof Jayashri Kulkarni, Professor of Pyschiatry 61-3-9076-6564 jayashri.kulkarni@med.monash.edu.au
Contact: Ms Heather Gilbert, RN Division 1/Research Nurse 61-3-9076-6591 H.Gilbert@monash.edu

Locations
Australia, Victoria
Monash Alfred Pyschiatry Research Centre, Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Prof Jayashri Kulkarni, Professor of Psychiatry    61-3-9076-6564    jayashri.kulkarni@med.monash.edu.au   
Contact: Ms Heather Gilbert, RN Division 1/Research Nurse    61-3-9076-6591    H.Gilbert@alfred.org.au   
Principal Investigator: Jayashri Kulkarni, Professor of Psychiatry         
Sponsors and Collaborators
The Alfred
Janssen-Cilag Ltd.
Investigators
Principal Investigator: Jayashri Kulkarni, Professor of Psychiatry Monash Alfred Psychiatry Research Centre (MAPrc)
  More Information

No publications provided

Responsible Party: Jayashri Kulkarni, Professor, Chief Investigator, The Alfred
ClinicalTrials.gov Identifier: NCT00686946     History of Changes
Other Study ID Numbers: 114/04, Not applicable at present
Study First Received: May 28, 2008
Last Updated: June 23, 2014
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
The National Register of Antipsychotic Medication in Pregnancy (NRAMP)
Antipsychotic medications
Pregnancy
Evidence-based guidelines
Maternal and infant health and wellbeing

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014