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.: PACTR202311817720428 Date of Approval: 09/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial to evaluate the performance and safety of the wekebere system for monitoring fetal wellbeing during labor
Official scientific title A clinical trial to evaluate the performance and safety of the wekebere system for monitoring fetal wellbeing during labor
Brief summary describing the background and objectives of the trial Globally, nearly three million babies are stillbirths annually. Majority of these are in low-income countries. These deaths have long term consequences on the parents and family. There are several causes of stillbirths, however the most common is birth asphyxia during childbirth. With the goal of helping midwives and expectant mothers to monitor the fetal wellbeing during pregnancy and labour, Wekebere Company limited has developed a novel fetal monitoring system for monitoring fetal heart rate so that fetal rate abnormalities during pregnancy and labor are detected. The main objective of the study is to assess the performance (accuracy) and safety of the novel fetal monitoring system (Wekebere) compared to the standard of care ( fetal Doppler) .
Type of trial RCT
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 Early detection /Screening
Anticipated trial start date 01/10/2023
Actual trial start date 10/10/2023
Anticipated date of last follow up 08/12/2023
Actual Last follow-up date 20/12/2023
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Wekebere Intervention Expectant mothers will be monitored continuously for 1 hour 1 hour In general, the treatment of a participant enrolled to the study will be performed according to the medical and hospital guidelines. Each recording session will last at least 1 hour as according to the standard of care.The wekebere fetal monitoring system will be connected and operated in the most continuous manner as possible recording the fetal cardiac activities and uterine activities, unless there is a necessity to disconnect the participant due to medical treatment or nursing reasons. The data will include the following: i. Fetal HR ii. Uterine activity The wekebere fetal monitoring system records will be identified by the participant's trial identification number. 120
Control Group Standard of care Every 10 minutes for one hour 1 hour During all study periods, participants will be monitored with Standard of Care every 10 minutes 120 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Female age between: 18-50 ii. Gestational age >36 + 0 weeks iii. Singleton pregnancy iv. Early labour (cervical dilatation of <6cm) v. Sign informed consent i. Female age between: 18-50 ii. Gestational age >36 + 0 weeks iii. Singleton pregnancy iv. Early labour (cervical dilatation of <6cm) v. Sign informed consent Adult: 19 Year-44 Year 18 Year(s) 50 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
Yes 05/11/2023 Makerere University School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
makerere University school of medicine Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Performance outcome: The primary performance outcome will be Fetal HR. This outcome will be collected via Wekebere fetal monitoring system and via the standard of care monitoring system (Doppler). every 15 minutes for 1 hour
Secondary Outcome The secondary performance endpoints will include be Uterine contractions. Wekebere fetal monitoring system also acquires and displays the UA (Uterine contractions) from the uterine Electro hysterography (EHG) signal. Contractions will be collected by wekebere fetal monitoring system and via the standard of care monitoring system (partograph). every 15 minutes for 1 hour
Primary Outcome Incidence of device related and/or protocol procedure related adverse events and/ or serious adverse events related to the study device, in pregnant women with singleton pregnancy > 36 + 0 weeks of gestation. 1 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kawempe National referal Hospital Kawempa kampala 7332 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Villgro Africa Bishop Magua Center, Off Ngogo Road, Upper ground Floor Unit 6 Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Vilgro Africa Bishop Magua Center, Off Ngogo Road, Upper ground Floor Unit 6 Nairobi Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Makerere University Makerere Kampala 7062 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sam ONONGE ononge2006@yahoo.com +256773683085 Makerere university school of medicine
City Postal code Country Position/Affiliation
Kampala 7062 Uganda Principle Investigator
Role Name Email Phone Street address
Scientific Enquiries Tashobya Stephen stashobya@gmail.com +256773683085 Plot 507 Upper mawanda road
City Postal code Country Position/Affiliation
Kampala 7222 Uganda CEo
Role Name Email Phone Street address
Public Enquiries Gerald Abaho ibragrld@gmail.com +256776654456 Plot 507 Upper mawanda road
City Postal code Country Position/Affiliation
Kampala 7222 Uganda Product Engineer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in maternal health. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 24 months To access the data one will have to first fill the request form for data that will be reviewed by the data management team before access is granted
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.wekebere.org 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