The National Register of Antipsychotic Medication in Pregnancy (NRAMP)

NCT00686946 | Unknown

• 1 other identifier: 114/04
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Mental Disorders

Keywords

Severe mental illness; Antipsychotic medications; Pregnancy; Evidence-based guidelines; Maternal and infant health and wellbeing

Outcome Measures

Primary Outcomes (1)

• Participant interviews

  Interviews to gather demographic, social, medical, psychiatric, medication and obstetric history

  Antenatal - once per trimester; Postnatal - quarterly for 12 months

Secondary Outcomes (2)

• Psychopathology measures for the mother

  Antenatal and up to 12 months postnatally

• Developmental Milestone measures for the baby

  Birth to 12 months of age

Study Arms (1)

NRAMP

Participants take their antipsychotic medication as prescribed by their clinical treating teams.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women from across Australia who are taking, or have taken, antipsychotic medication during pregnancy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Janssen-Cilag Ltd.: collaborator
• AstraZeneca: collaborator
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Monash Alfred Pyschiatry Research Centre, Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Prof Jayashri Kulkarni, MBBS,FRANZCP

  Monash Alfred Psychiatry Research Centre (MAPrc)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Jayashri Kulkarni, MBBS,FRANZCP

CONTACT

61-3-9076-6564; jayashri.kulkarni@med.monash.edu.au

Ms Alisa Turbic, BSc

CONTACT

61-3-9076-6591; maprc-nramp@monash.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: May 30, 2008
• Study Start: January 1, 2005
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)