Information sheet

Please take some time to read this information and ask questions if anything is unclear. Contact details can be found at the end of this document.

What is the purpose of this study?

This study aims to test the efficacy and performance of a novel intelligent and Artificial Intelligence (AI) powered clinical decision support (CDS) system that was recently developed by Spiker Ltd. The CDS automatically analyses the CTG traces and provides feedback to an obstetrician or midwife and helps him/her make an evidence-based decision on your treatment. The results of the clinical trial will be used in acquiring national and international certification before the device is mass-produced and distributed in Africa in general, and in Rwanda in particular.

Who is organizing this research?

The research for this study is being undertaken by Spiker Ltd, a Japanese healthcare company. The Rwandan National Ethical Committee Council (RNEC) has reviewed and approved this research.

Why have I been chosen?

You were selected as a possible participant in this study because you are a healthy patient with a singleton pregnancy and you are at least 18 years old. Your participation in this research is voluntary and you can withdraw at any time.

Do I have to take part?

Participation in this study is voluntary and you may ask the researcher questions before agreeing to participate. Although you may not directly benefit from taking part in this study, the proposed clinical decision support software might improve how your doctor interprets your CTG during labor. Moreover, your participation in this study may help in engineering a CTG machine that will help in reducing deaths due to complications from childbirth. If you agree to participate, you will be asked to sign a consent form. However, at any time, you are free to withdraw from the study and if you choose to withdraw, we will not ask you to give any reasons.

What if I refuse to take part in the study?

If you choose not to participate, that will not affect your relationship with the trial hospital, the principal, and co-principal investigators and will not affect your right to health care or other services to which you are otherwise entitled.

What will happen to me if I take part?

If you agree to take part in this study, you will undergo some activities, tests, and evaluations to determine if you are eligible for this study. Such tests and evaluations are completed during a screening period that takes place before your labor and delivery. Also, depending decision made by your doctor, you will undergo your labor and delivery with a CTG machine that records and automatically analyses the heartbeats of your baby. In practice, the CDSS is safe because it is based on a certified CTG machine that is already used in most hospitals in Rwanda. The only difference, in your case, will be that the clinical support system will give more information to your doctor. We may ask you to participate in a follow-up interview, though participation in this is optional.

Can the research or my participation be terminated early?

Your participation in this research is completely voluntary. If you choose to participate you may subsequently withdraw from the study at any time without penalty or consequences of any kind. The investigator or your physician may withdraw you from participating in this research if circumstances arise that warrant doing so. The decision may be made either to protect your health and safety or because it is part of the research plan that people who develop certain conditions may not continue to participate.

What are my alternatives if I do not participate in this study?

Instead of participating in the study, you may elect to take the normal treatment for your condition. The researcher will discuss with you the benefits and risks of these standard treatments. You are not obliged to participate in this clinical trial in order to receive care and treatment for your condition.

What are the possible benefits of participating?

Although we expect that the clinical decision system will improve your doctor’s ability to make timely and informed clinical decisions during your delivery and labor, there is no promise that you will receive any personal benefit from taking part in this clinical study. Although you may not directly benefit from taking part in this study, your participation in this study may help in engineering a CTG machine that will help in reducing deaths due to complications from childbirth.

What are the possible risks of taking part?

The clinical decision system only analyses the heartbeats of your baby. Thus, there is no anticipated risk or discomfort.

Will my medical information be kept private?

All documents that identify you will be held in the strictest confidence and will not be released to the public. The physician and research team will use your personal information to perform the study. In some exceptional cases, the representatives of governmental regulatory agencies will have access to your personal information. These persons will be required to keep this information confidential.

What happens to data collected during the study?

The data collected during this research will be stored, managed by the researcher for the duration of the project.

Who should I call if I have questions?

If you have any questions about the study or if you think you have a study-related injury and you want information about treatment, please contact

• Dr. Vincent Dusingizimana (Tel: 078-821-4231) for medical information on this study,
• Dr. Kizito Nkurikiyeyezu (Tel:078-714-7380) for other general questions related to the working principle of the CTG machine and other information related to this clinical trial
• Dr. Jean Baptiste Mazarati (Tel: 0788 309 807), the chairperson of Rwanda National Ethics Committee, if you have questions, concerns, or complaints about your rights as a research participant.

What should I do if I have any concerns or complaints?

If you have any concerns about the project, please speak to the researcher, who should acknowledge your concerns and give you an indication of how your concern will be addressed. If you remain unhappy or wish to make a formal complaint, please contact Dr. Jean Baptiste Mazarati (Tel: 0788 309 807), the chairperson of the Rwanda National Ethics Committee.