FAQs

 What is NRAMP?


NRAMP is an observational, nationwide study which follows the journey of mother and baby during pregnancy, delivery and for the first year of the baby’s life. It is designed to collect and record information on maternal and neonatal health and wellbeing during this time frame.  It is not designed to provide treatment recommendations, make mental health diagnoses or pass judgement on any individual.
 

What does NRAMP aim to achieve?

NRAMP aims to:
  • Provide a better understanding of antipsychotic medication use during pregnancy, birth and for the first year of the baby’s life
  • Allow for the development of evidence-based medication saftey guidelines for the best use and effect of antipsychotic medication during pregnancy, birth and the postnatal phase
  • Assist healthcare professionals, and women with mental illness, to make informed decisions about appropriate treatment options, and encourage safer outcomes for both mother and baby, during pregnancy, birth and the postnatal phase
  • Enhance our knowledge regarding the care of women with mental illness during pregnancy, birth and the postnatal phase

Who can take part in NRAMP?

  • Women who take antipsychotic medication during pregnancy
  • Women who are pregnant or who have had a baby in the last 12 months
  • Women who reside in Australia
  • Women who are able to give informed consent

How can women join NRAMP?

Referral by clinicians: Healthcare professionals can refer potential participants to NRAMP. Clinicians are asked to briefly discuss the study with appropriate patients, and to ask their consent to pass on contact details to NRAMP research personnel, who will then contact the potential participant to discuss participation in the study.

By self-referral: Women who are interested in participating in the study can contact NRAMP research personnel directly.

 

Is participation in NRAMP voluntary?

Yes, participation in NRAMP is completely voluntary, which means that participants may also withdraw from the study at any time, should they wish to do so, without jeopardising their clinical care. Participants may also request that their personal information be removed from the register at any time.

What about Consent?

To be able to take part in the study, potential participants will be required to sign two Consent Forms, a Participation Consent Form and a Medical Consent Form.  These Consent Forms protect the potential participant’s privacy and the confidentiality of the potential participant’s personal information.  The Consent Forms also allow the NRAMP research personnel to contact the potential participant’s treating team to obtain further information, if required.  This is explained to potential participants when they are introduced to the study, in the recruitment phase.

What happens to participants’ personal information?

Any information collected as part of the NRAMP study, and which can identify any individual participant, will remain confidential. Participants’ information is stored in locked filing cabinets, within a locked office,  and is accessible to NRAMP research personnel only.

Information about a participant can be disclosed only with that person’s permission, except where required by law or if there are clear management issues requiring information to be shared with the treating team.

During the study and at its completion, NRAMP research personnel  plan to publish the ongoing observations, making them available to healthcare professionals in the form of evidence-based guidelines for the care of women with mental illness during pregnancy. Observations may also be published in relevant and reputable scientific journals and presented at conferences and seminars.  Such observations will not contain any details that could be used to identify individuals.

What are the benefits of taking part in NRAMP?

Taking part in NRAMP has a number of possible benefits.

  • These include an ongoing supportive relationship with NRAMP research personnel, who are health professionals.
  • The participant’s clinical treating team may have an increased awareness of their patient’s needs during pregnancy, including her experiences of motherhood.
  • Participants are providing a vital contribution to the development of best-practice guidelines for the treatment of women with mental illness during and after pregnancy, and are therefore helping not only themselves and their babies, but also other women and their babies in the future.

Are there any risks associated with taking part in NRAMP?

Possible side-effects or discomforts that might occur include feelings of sadness which may result from telling the NRAMP research personnel about life experiences. NRAMP research personnel do not play any role in the management of the participant’s mental illness or pregnancy, however,  if the NRAMP research personnel have any concerns for the health or wellbeing of the participant, or her baby, these will be directed to the participant’s clinical treating team.

Does NRAMP have ethics approval?

Yes, NRAMP has ethics approval with the Alfred Hospital, Melbourne, Victoria, plus several other Ethics Committees across Australia. The study will be carried out according to the National Statement of Ethical Conduct in Human Research (2007), produced by the National Health and Medical Research Council of Australia (NH&MRC). This statement has been developed to protect the interests of people who agree to participate in human research studies.

Is NRAMP supported by any organisations?

Several organisations have generously provided support for NRAMP, and include:

  • Janssen-Cilag
  • AstraZeneca
  • Hospira
  • Lilly
  • Australian Rotary Health Research Fund

Are participants paid for taking part in NRAMP?

No, participants do not receive any monetary reimbursement for taking part in NRAMP.

Who are the NRAMP research personnel?

NRAMP Chief Investigator: 
Professor Jayashri Kulkarni
Monash Alfred Psychiatry Research Centre (MAPrc)

NRAMP Co-ordinator/Senior Clinical Research Nurse:
Ms Heather Gilbert
Monash Alfred Psychiatry Research Centre (MAPrc)

Who can I contact for further information?

For enquiries or referrals, please contact:

Ms Heather Gilbert
Senior Clinical Research Nurse/NRAMP Co-ordinator
Phone: + 61 3 9076 6591
Email: heather.gilbert@monash.edu

 

 

 

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