Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311722468070 Date of Approval: 21/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Feasibility And Acceptability Of Integrating The EchOpen O1 Device In Pregnancy Monitoring In Three Maternity Hospitals In Benin
Official scientific title Feasibility And Acceptability Of Integrating The EchOpen O1 Device In Pregnancy Monitoring In Three Maternity Hospitals In Benin
Brief summary describing the background and objectives of the trial Today, in under-medicalised areas, both in developing countries and in the medical deserts of so-called developed countries, the ultra-portable probes available for monitoring pregnancies cost between €8,000 and €15,000. This situation prevents all healthcare professionals and their patients from having access to them. To help reduce maternal-foetal mortality, it is important to offer solutions that are less expensive and accessible to all. It is in this context that the echOpen O1 probe developed by echOpen Factory, after several years of research and development, has become a reality. The tool is being developed by echOpen Factory, with an international open-source and collaborative community aiming to revolutionise clinical examination, and facilitate rapid care for participants, whether in hospital or in isolated health centres. As presented, the echOpen O1 probe is a robust, affordable tool that can be used anywhere, anytime. It produces imagery that can be shared digitally on a smartphone, for interpretation support by specialists. Nevertheless, echostethoscopy does not replace complementary imaging examinations, of which ultrasound is a part, but is a genuine diagnostic tool. Better still, it offers the possibility of filling a gap in access to visualising the inside of the body from the very first contact with patients, by a large number of healthcare professionals trained in this approach. With a view to bringing this ultra-portable, affordable, open-source probe connected to a smartphone to market, a clinical investigation into the feasibility and acceptability to users is being undertaken. In this context, the aim of our study is to identify the factors that will influence the acceptability of the echOpen O1 probe, which will favour its use in routine antenatal monitoring.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 08/01/2024
Actual trial start date
Anticipated date of last follow up 08/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 292
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound scan with the echOpen O1 probe Less than 5 min To carry out an ultrasound scan with the echOpen O1 probe for pregnant women in their third trimester attending antenatal clinics in the study's target maternity units. 292
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- In the first phase of the study (the first three months): All pregnant women attending antenatal clinics in one of the three study pilot maternity units, aged at least 18, with a pregnancy of at least 37 weeks' amenorrhoea (SA), who had given their informed consent to receive free exploration with the echOpen O1 probe and any other stakeholder from one of the study sites who had given their written informed consent to participate in the sociological study. - In the second phase of the study (last three months): All pregnant women attending antenatal clinics in one of the three study pilot maternity units, aged at least 18 years, with a pregnancy of at least 29 SA, who had given their informed consent to receive free exploration with the echOpen O1 probe and any other stakeholder from one of the study sites who had given their written informed consent to participate in the sociological study. - Pregnant women (or pregnant women) with a pregnancy complication or comorbidity, or who have not given informed consent to participate in the study, - Pregnant women in labour, - Midwives practising solely in the delivery room (case of the CHU-MEL) or who had not given their written consent to participate in the sociological study, - Other stakeholders from one of the study sites who did not give written informed consent to participate in the sociological study. - Significant clinical evidence (in the opinion of the investigator) of a health problem or abnormality likely to compromise the safety or interpretation of the efficacy of the clinical study. Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/05/2023 CNERS
Ethics Committee Address
Street address City Postal code Country
Avenue Jean-Paul II, Cotonou, Cotonou 229 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The specific objectives of this research are : - To summarize the uses of the usual probes available in obstetrics and gynaecology, - Assess the added value of the echOpen O1 probe in building midwives' capacity, - Document the factors that may influence the acceptability of integrating the echOpen O1 probe among pregnant women and the various players involved, - Evaluate the accuracy of referral diagnoses and midwives' familiarity with the tool. At the end of the recruitment process
Secondary Outcome The added value that the echopen O1 probe brings to diagnosis in under-medicalised areas. At the end of the recruitment process
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CHU MEL Rue des Dako Donou Cotonou 229 Benin
HZ Come Rue Hopital de Zone Come 229 Benin
CS ADJARA Rue Centre de Sante Adjara Adjara 229 Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
EchOpen Foundation Parvis Notre-Dame Place Jean-Paul II 75004 Paris France, Metropolitan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor EchOpen Foundation Parvis Notre-Dame Place Jean-Paul II 75004 Paris France, Metropolitan Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
DEGNONVI Horace 01 BP 1463 Cotonou Benin
DENAKPO Justin 01 BP 386 Cotonou Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justin DENAKPO justindenakpo@gmail.com 0022995426719 01 BP 386
City Postal code Country Position/Affiliation
Cotonou Benin Head of the University Clinical Department of Gynaecology Obstetrics
Role Name Email Phone Street address
Scientific Enquiries Horace DEGNONVI degnonvihorace@gmail.com 0022997122545 01 BP 1463
City Postal code Country Position/Affiliation
Cotonou Benin Project Manager and Coordinating Investigator
Role Name Email Phone Street address
Public Enquiries Aubierge Kpatinvoh aubierge.kpatinvoh@echopen.org 0022966859972 01 BP 386
City Postal code Country Position/Affiliation
Cotonou Benin Health socioanthropologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data will be hosted on the Health Data Hosting (HDS) server at OVH based in Strasbourg, France. This is a secure site that meets international standards for the storage of health data. Pseudonymisation will be respected in all uses of the results. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD and additional document types will be available six month after completion of the trial Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information