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.: PACTR202304639669676 Date of Approval: 11/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Optimization of community-level antenatal risk identification for control of hypertension disorder in pregnancy in rural district of South Gondar Zone, Northwest Ethiopia
Official scientific title Optimization of community-level antenatal risk identification for control of hypertension disorder in pregnancy
Brief summary describing the background and objectives of the trial In Ethiopia, hypertensive disorders of pregnancy (HDP) are the second leading cause of maternal death. Community level antenatal risk stratification is needed to reduce the adverse maternal and neonatal outcome and late presentation to health facility. The homegrown innovation, community health extension program, is one of the stellar flagship health program in Ethiopia. This grassroot health cadres have been a success story in dispensing their responsibility of promoting health, improving health outcomes and alleviating health inequity, particularly in rural and hard to reach populations. The overall aim of this research project is to design an implementation strategy to investigate community level antenatal risk identification and enhance health extension workers competency to detect, refer, and manage hypertension disorder in pregnancy in rural district of South Gondar Zone, Northwest Ethiopia. This study protocol outlines the Implementation research using theoretical domain framework strategy. The specific objectives of the project are: 1. To investigate the barriers, facilitators, and roles of health extension workers in early detection and management of hypertensive disorder of pregnancy at primary health care level 2. To develop implementation strategy and risk stratification algorithm for hypertension disorder during pregnancy that can be used by health extension workers to facilitate their decision making and linkage to subsequent maternal care 3. To improve health extension workers competency in monitoring pregnant women blood pressure, detect elevated BP and referral linkage 4. To assess the feasibility and acceptability of community health extension workers at the lowest level of primary health care (health post) to identify hypertension disorder during pregnancy
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/04/2022
Actual trial start date 01/05/2022
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date 01/07/2023
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants)
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study 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 Locally adapted HDP risk identification compared to the usual care 3 months A semi-automated Microlife CRADLE VSA BP apartus which is a WHO approved with a novel warning system will be distributed to health posts. A targeted educational and training component will be developed and delivered for health extension workers on HDP in line with the implementation strategies. A short film on how to take BP of pregnant women will prepared and distributed for health extension workers using CD, DVD, pen drives, and Bluetooth. We will develop a hypertensive disorder of pregnancy risk stratification algorithm to aid health extension workers take BP of pregnant women, repeat and link to higher maternal care. 115
Control Group Usual care 3 months Usual care 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will include HEWs with educational status levels 4 and above. HEWs on maternity leave and/or on extended sick leave during the study period will be excluded. Adult: 19 Year-44 Year 19 Year(s) 44 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 22/02/2022 University of Gondar
Ethics Committee Address
Street address City Postal code Country
Maraki Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Competency of health extension workers (HEW) with use of BP device - % HEWs that can properly apply the BP device’s cuff - % HEWS that identify the systolic and diastolic readings on the device - % HEWs that can interpret the traffic colours on the device - % of HEWs that can define the error messages on the device End of followup period
Secondary Outcome Mean knowledge of hypertensive disorder during pregnancy and its related complications End of followup period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health post N/A Debre Tabor Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
JHU N/A Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Maraki Gondar 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Achenef Muche ashua2014@gmail.com +251939529888 Chechela
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Achenef Muche ashua2014@gmail.com +251939529888 Chechela
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Achenef Muche ashua2014@gmail.com +251939529888 Chechela
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After deidentification, individual participant data that underpin the results reported in the form manuscripts (text, tables, figures, and appendices). Moreover, the data will be presented to all stakeholders, all concerned governmental bodies, and non-governmental organizations, in the form of short reports in local languages and policy briefs. If participants require a project summary report, they can obtain it at their respective health facilities at the end of the study. Study Protocol After the datasets generated during and/or analysed for publications After the datasets generated during and/or analysed for publications
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