MBM Trial Participant Information

MBM Trial Information Participant Information Recruitment Participating Hospitals Documents

Thank you for your interest in the My Baby's Movements study.

The purpose of the study is to raise pregnant women’s knowledge and awareness of their baby's movements during pregnancy. This study is open to women who are currently pregnant with one baby and are attending antenatal care at participating hospitals. The study will be conducted across multiple hospitals in Australia and New Zealand and has been funded by a National Health and Medical Research Council (NHMRC) Project Grant.

1.1 What does participation in this study involve?

Women who are eligible for the study will be offered the 'My Baby's Movements' (MBM) app to use from 27-28 weeks of gestation onwards. Using this app is entirely voluntary. Women who do not have a smartphone will be signed up to receive SMS messages about the babies' movements. If you do not wish to receive these SMS messages, you may opt out by telling your care provides.

1.2 What is My Baby's Movements (MBM)?

MBM is a mobile phone software program designed to increase pregnant women's awareness of fetal movements. MBM will provide information and 'prompts' about fetal movements, and is intended to support women's decision-making about seeking care if DFM occurs. MBM will be available as an app for smartphone users, or as an SMS program for nonsmartphone users. Importantly, MBM is not designed to replace any aspect of standard antenatal care, but rather to enhance and facilitate standard antenatal care.

Some women will also be asked to complete a survey about their baby’s movements and the information they have previously received about babies’ movements. A follow-up survey will be sent out 6 months after birth by mail or email.

1.3 Other relevant information about the study

All data collected in this study will be de-identified, collated and used to inform clinical practice. The results of the study will be published and presented in a variety of forms. In any publication and/or presentation, information will be provided in such a way that no individual participant can be identified. A summary of results will also be made publicly available via the research team’s website.

1.4 What if I do not want to be in the study?

Participation is voluntary and you are free to decide whether or not to participate. If you agree to participate you are also free to change your mind at any time and without offering a reason. Declining the project or withdrawing from the study will not affect your routine care, relationships with professional staff or ongoing relationship with your Health Services provider.

1.5 What are the possible risks/benefits of participating?

While many women find thinking about and feeling their baby’s movements reassuring some women may feel worried about their baby’s movements. If at any time you feel worried, you are encouraged to seek advice from your care providers. Please be aware that you and your baby may not receive any direct benefits from this research.

1.6 What if I want to withdraw after starting the study?

You may withdraw from the study at any time. If you decide to withdraw, please contact the site study coordinator. If you do withdraw, you may be asked to complete and sign a ‘Withdrawal of Consent’ form; this will be provided to you.

If you decide to leave the study, the researchers will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the study can be measured properly and to comply with law. You should be aware that data collected up to the time of withdrawal will form part of the study results. If you do not want your information to be included, you must tell the researchers when withdrawing from the study.

1.7 What happens when the study ends?

Copies of information provided by participants will be kept for 15 years following completion of the study and publication of results. Electronic data will be disposed of securely and any printed copies of research data will be shredded and disposed of.

Part 2 How the study is being conducted?

2.1 What will happen to information about the participant?

Any information about you or your baby collected in this study will remain confidential and will not be disclosed without your permission, except as required by law.

Electronic data will be stored on a secure network database, and is only accessible by approved individuals. Electronic data stored on the network drive will be in password protected folders, only accessible to the research team. Medical information that is routinely collected at hospitals will be de-identified (i.e., names removed) and will only be accessible to the research team. Completed surveys and forms will be securely stored at the coordinating centre at the Mater Research Institute, University of Queensland, Brisbane, Australia.

With your consent, if you live in Australia, Mater Research Institute – The University of Queensland will obtain your Medicare claim data from the Department of Human Services. The Medicare system provides reimbursement for the pharmaceutical benefits schedule (PBS) and medical benefits schedule (MBS) health care costs incurred by individuals within Australia, as well as visits to medical practitioners and specialists. This information will be used to complete a cost-analysis as part of this study.

You can withhold consent for access to your Medicare data, even if you choose to be involved in the other aspects of the study. A standard Medicare form will need to be completed for release of this data.

2.2 Who has reviewed the study?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the appropriate HREC. This project will be carried out according to the National Statement on Ethical Conduct in Human Research. This statement has been developed to protect the interests of people who agree to participate in human research studies.

2.3 Further information and who to contact

The person you may need to contact will depend on the nature of your query. If you would like any further information concerning this study or if you have any problems which may be related to involvement in the study, contact the Site Study Coordinator.

2.4 Complaints

If you have any complaints about any aspect of the study, the way it is being conducted, or if you have any questions about being a research participant in general, and you do not wish to speak to those involved with the research team, please contact the Human Research Ethics Office for your Health Services provider.