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.: PACTR201902736872339 Date of Approval: 11/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title MAKER FOR MNCH
Official scientific title CLINICAL PROTOCOL FOR ASSESSING THE SAFETY AND EFFECTIVENESS OF LOCALLY MANUFACTURED LOW COST MEDICAL EQUIPMENT FOR MATERNAL, NEWBORN, AND CHILD HEALTH: A PROSPECTIVE, NON-RANDOMIZED, QUASI- EXPERIMENTAL, CONTROLLED TRIAL FOR THE IMPROVEMENT OF MATERNAL, NEWBORN, AND CHILD HEALTHCARE IN NAIROBI, KENYA
Brief summary describing the background and objectives of the trial Medical equipment and devices are essential in the provision of quality maternal and newborn care. However, resource limited countries have challenges in access to basic equipment and devices of the high cost of buying and capacity to service and maintain them. The objective of the clinical trial will be to evaluate the effectiveness, safety, reliability, acceptability and cost- effectiveness of locally made low cost infant phototherapy machine, delivery vacuum extractor, suction aspirator and examination light by comparing to standard of care equipment
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/12/2018
Actual trial start date
Anticipated date of last follow up 30/06/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Suction Aspirator single use per patient Time when suction aspirator is broken down Evaluation of suction aspirator.The primary outcome of interest is the effectiveness/functionality of the suction aspirator. A 100 case records will be randomly selected for each of the equipment (standard of care devices and Maker devices) will be examined for adverse events to assess safety. 50
Control Group Standard of Care single use per patient Time taken to remove aspirate Observe the ability to remove and the amount of aspirate removed from mothers and infants 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Women undergoing cesarean section 2. Neonates requiring suction during delivery 3. Informed consent from women undergoing cesarean section 1. Women with other co-morbidities 2. Neonates with comorbidities including a diagnosis of non-reassuring fetal state. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 0 Day(s) 49 Year(s) Both
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 04/05/2015 KNHUONERC
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Functionality 2. Ease Of Use 3. Frequency Of Break Down 4. Number of break downs 5. Total Break Down Time 6. Access Of Spare Parts During and immediately after use
Secondary Outcome Number Of Adverse Events During and immediately after use
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Concern Worldwide Peponi Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Science Technology Park University of Nairobi Maker Project Loresho Ridge Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Kenyatta National Hospital Hospital Road Nairobi 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Ayah ayah@uonbi.ac.ke 2547209420526 Loresho Ridge
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Director Science and Technology Park University of Nairobi
Role Name Email Phone Street address
Public Enquiries John Ongech jongech@yahoo.com 254722282449 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Deputy Director Surgical Services Kenyatta National Hospital
Role Name Email Phone Street address
Scientific Enquiries Rose Kosgei salilkabon@yahoo.com +254722273443 Hospital Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Senior Lecturer Department of Obstetrics Gynaecology University of Nairobi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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