The National Register of Antipsychotic Medication in Pregnancy (NRAMP) (NRAMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00686946|
Recruitment Status : Recruiting
First Posted : May 30, 2008
Last Update Posted : March 14, 2018
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 or disease|
|Pregnancy Mental Disorders|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The National Register of Antipsychotic Medication in Pregnancy (NRAMP)|
|Actual Study Start Date :||January 2005|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Participants take their antipsychotic medication as prescribed by their clinical treating teams.
- Participant interviews [ Time Frame: Antenatal - once per trimester; Postnatal - quarterly for 12 months ]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 ]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 ]ASQ-3 (Ages and Stages Questionnaire, Third Edition)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686946
|Contact: Prof Jayashri Kulkarni, MBBS,FRANZCPfirstname.lastname@example.org|
|Contact: Ms Heather Gilbert, RN Div email@example.com|
|Monash Alfred Pyschiatry Research Centre, Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Prof Jayashri Kulkarni, MBBS,FRANZCP 61-3-9076-6564 firstname.lastname@example.org|
|Contact: Ms Heather Gilbert, RN Div 1 61-3-9076-6591 email@example.com|
|Principal Investigator: Prof Jayashri Kulkarni, MBBS,FRANZCP|
|Principal Investigator:||Prof Jayashri Kulkarni, MBBS,FRANZCP||Monash Alfred Psychiatry Research Centre (MAPrc)|