study protocols

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PRÉCIS

This will be a randomized controlled study evaluating the performance of a novel intelligent and Artificial Intelligence (AI) powered clinical decision support (CDS) system that was recently developed by Spiker Ltd. The study will comprise approximately 200 healthy pregnant women who are 18 years of age or older. The participants will be randomized 1:1 to undergo their labor and delivery care with or without the novel CDS system. 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.

AIM AND OBJECTIVES

Aims

The principal purpose of this clinical trial is to appraise the efficacy of the proposed CDS system in assessing a fetus’s well-being and its use in enhancing outcomes for babies during labor and delivery.

Objectives

The study has the following objectives:

  • To evaluate the CDS system as a tool to improve CTG analysis and interpretation.
  • To deploy the CDS system in hospitals in Rwanda and assess its performance in clinical settings and examine whether it satisfies performance standards for medical devices.
  • To collect data that validate the design decision, the performance of the machine learning models and identify any areas of improvement.
  • To collect safety and effectiveness data for future marketing applications.

STUDY DESCRIPTION

This clinical trial will use a randomized control trial (RCT). The participants will be randomized into two groups. The first group will be monitored by the traditional CTG machines that are already available in all Rwandan hospitals. On the contrary, the second group will be monitored by the new AI-supported CTG machine. The members of the two groups will be chosen at random from the eligible population. In principle, neither the patient nor the patient’s obstetrician will decide which group each subject is assigned to. However, this can be amended in case of emergency and at the sole discretion of the subject’s obstetrician.

STUDY DESIGN

The study will involve approximately 200 healthy pregnant women who are 18 years of age or older and who are expected to undergo their planned labor and delivery at the selected trial hospitals. One control group of about 100 subjects will undergo typical labor and delivery with the traditional CTG machines that are used throughout Rwandan hospitals. The other group will undergo their labor and delivery with a CTG supported by the proposed CDS system.

Data will be wirelessly collected and saved for future analysis. At the same time, midwives at the Mother Key Medical Group in Japan will remotely look at the CTG graph and assess and annotate the performance of the CDS system. To comply with the Rwanda laws related to the protection of personal data and privacy , no data will be sent to Japan or shared with any third party without explicit permission from the clinical trial participants and as stipulated in the consent form.

INCLUSION AND EXCLUSION CRITERIA

Inclusion criteria

  • Healthy women≥18 years of age, with an uncomplicated, singleton pregnancy, who have no known increased risk for complications and who are scheduled for vaginal delivery.
  • Healthy women who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study
  • Participants are willing to give informed consent to participate in the study
  • Capable of giving signed informed consent
  • Fluent in Kinyarwanda or English

Exclusion criteria

  • Women aged less than 18 years old
  • Women with a notable medical history as determined by the principal investigation team and/or the patient’s gynecologist.
  • Women with multiple pregnancies
  • Women with fetal malformations
  • Women with uncertain pregnancy dating
  • Pregnant women that the hospital’s gynecologist deems inappropriate for the study
  • Women who cannot speak Kinyarwanda, French, or English
  • Subjects who refuse to give a signed and dated informed consent

ETHICAL CONSIDERATIONS

Confidentiality

All documents that identify the subject will be held in the strictest confidence and will not be released to the public. The clinical investigator, the research team, the Sponsor will use the personal information solely to perform the clinical trial study. This information may include names, medical history, and data from the patient’s medical consultations. However, this information will not be entered into the study data sent to the sponsor or his representatives. The subject will only be identified by a code number in each report for any publication produced based on this study. The only people who will know the participating subjects that are the members of the research team which might include outside collaborators not affiliated with the Sponsor and, if appropriate, the patient’s physicians and nurses. No information about the subject will be disclosed to others without the subject’s written permission, except if necessary to protect the subject’s rights or welfare, or if required by law. In addition, the subject’s information may be reviewed by authorized representatives of the Sponsor to ensure compliance with its policies.

When the results of the research are published or discussed in conferences, no information will be included that would reveal the subjects’ identities. If photographs, videos, or audio-tape recordings of the subjects are recorded, the subjects’ identities will be protected or disguised.

In order to ensure that the study data collected about the subjects are correct and truly relate to the given subjects, a group of hand-picked individuals who work for the Sponsor, as well as representatives of governmental regulatory agencies, and members of the Ethics Committee may access to the subjects’ personal information at the research center. These persons will be required to keep this information confidential.

The sponsor, his engineering team, or his representatives may use the data from the study, which are sent to them, for the following purposes:

  • To see if the CDS system is working properly
  • To compare the CDS system’s performance with other similar products
  • For other activities related to the development and improvements of the system. Authorized representatives of the Rwanda Food and Drug Administration (FDA) and the Rwanda National Ethics Committee (RNEC) may also need to review the records of individual subjects. As a result, they may see the subject’s personal information. However, any member of the regulation personnel should keep confidentiality of the data as per the rule of confidentiality of their organization and with respect to Rwanda’s Data Protection Laws

The participant must personally sign and date the latest approved version of the informed consent form before any study-specific procedures are performed. Written and verbal versions of the participant information and Informed consent will be presented to the participants detailing the exact nature of the study and the implications and risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal.

The participant will be allowed as much time as she wishes to consider the information, and the opportunity to question the Investigator, their obstetrician, or other independent parties to decide whether they will participate in the study. Written Informed Consent will then be obtained via the participants’ dated signature of the person who presented and obtained the informed consent. The person who obtained the consent must be suitably qualified and experienced and have been authorized to do so by the Principal Investigator. A copy of the informed consent document will be sent to potential subjects with the screening/enrollment appointment letter to allow ample time for review with family members. Designated study personnel will consent subjects at the beginning of the initial study/screening appointment. These staff members have been trained in all study procedures and are familiar with consenting to the procedures in the proposed study.

Staff will begin the process with a brief description of research consent and how it is different from clinical care. A broad overview of the study will be presented and pending continued interest, the staff member will conduct a detailed review with the potential subject and family (if available). One of the physician investigators or delegated competent personnel will be available to answer any questions during the consent process. Interested subjects will be presented with a series of open-ended questions designed to assess understanding of study participation, as well as an appreciation for voluntariness and the right to withdraw. Staff will re-educate the subject to correct misperceptions, incomplete, or incorrect answers. The subject will be asked to sign the informed Consent Form. The authorized study personnel obtaining consent also signs the form. Subjects who consent to participate are provided with a signed copy of the consent document as well as contact cards for the principal investigators. A summary of the consent process will be documented in the medical record and will include a statement that written informed consent was obtained before the participant was enrolled. The consent form will clearly state that participation is voluntary and there is no repercussion for refusal to participate in the study or withdrawal from the study.

Publication and data sharing policy

The preparation and submittal for publication of manuscripts containing the study results shall be in accordance with a process determined by mutual written agreement among the study Sponsor and participating institutions. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, the Rwanda data protection law.