This Informed Consent Form is for pregnant women who attend a select number of hospitals in Rwanda and who we are inviting to participate in research on a study for an Intelligent Cardiotocography (CTG) with Real-time Alerts for an Improved Labor and Delivery. 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. The study has been approved by the Rwanda National Ethics Committee (RNEC). Additionally, the trial will be conducted in accordance with the Helsinki Declaration and the Guide on Best Clinical Practices. The study investigation team will be paid by the sponsor (Spiker Ltd) for conducting the clinical trial

Goals of the study

The present study aims to understand the performance of a customized CTG machine that was recently developed by Spiker Ltd. The new CTG machine is powered by the latest advances in Artificial Intelligence (AI) and aims to automate CTG analysis in real-time, streamline CTG graphs interpretation and send alerts to medical personnel depending on the health status of the fetus.

Participation and Withdrawal

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. 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.

Study procedure

Spiker Ltd.’s custom CTG machine will be installed in the trial hospital and the medical personnel will use it according to the hospital’s existing regulations and guidelines on the use of CTG during pregnancy and labor. The CTG will simultaneously record the fetal heart rate (FHR) variability and the uterine contraction. The CTG device will automatically analyze these recorded signals and provide key information on the well-being of the fetus. For the purpose of the clinical trial, Mother Key Medical group in Japan will remotely assess the performance of the machine.

Risks & Potential Discomfort

There is no anticipated discomfort for those participating in this clinical trial, so the risk to participants is minimal. Mild discomfort may result from the normal usage of the CTG when the CTG transducers and its elastic belt are placed on your abdomen. You must inform the study physician as soon as you notice any negative effect, injury, or complication that may be linked to the treatment in the study. The state of your health could remain unchanged by participating in this study, or it could be altered. There can also be as yet unknown risks from using experimental treatment. You will be informed of any significant new development that could impact the continuity of this study.

Insurance

The sponsor undertakes to pay all reasonable medical expenses if an incident or injury should occur, which directly stems from participating in the trial. In general, the health insurance provider will pay the compensation without your having to prove fault for any injury directly resulting from administering experimental treatment or other procedures performed in accordance with the protocol for this study. However, the sponsor will not be liable for any loss, injury, and/or damage resulting from injury caused from departing from study protocols or injuries resulting from negligence on your part.

Benefits

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.

Confidentiality

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. Authorized representatives of the Rwanda Food and Drug Administration (FDA) and the Rwanda National Ethics Committee (RNEC) may need to review records of individual subjects. As a result, they may see your name; but they are bound by rules of confidentiality not to reveal your identity to others.

Payment, expenses, and costs

You will not receive any salary for participating in this study. The sponsor will pay the costs of the experimental treatment, supplemental examinations, and procedures specified in the protocol. Neither you nor your health insurance will pay these expenses.

End of participation in the study

Your participation in the study can be terminated for any of the following reasons:

You do not follow the research physician’s instructions
You do not take the research treatment as prescribed
The research physician decides termination is in your best interests
There are insufficient participants in the study or the number of participants planned is already reached
The sponsor or research center terminates the study for unspecified reasons.
The sponsor disbands the group you are in for an unspecified reason.

Contacts for answers relating to this clinical trial

For medical information on this study, please contact Dr. Dusingizimana Vincent at 078-821-4231. For other general questions related to the working principle of the CTG machine and other information related to this clinical trial, please do not hesitate to contact Dr. Kizito Nkurikiyeyezu at 078-714-7380.

If you have questions, concerns, or complaints about your rights as a research participant, please contact the chairperson of Rwanda National Ethics Committee, Dr. Jean Baptiste Mazarati (Tel: 0788 309 807) or Assistant Prof David Tumusiime (07887493948)

By signing the above, I acknowledge that:

I have read the information sheet and consent form, version 1.0 for this study
I had the opportunity to ask questions and the answers were satisfactory for me
I took time to discuss this information with others and to decide to take part or not
I will receive a dated and signed copy of the consent form
I agree to take part in this study.