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.: PACTR202203807835401 Date of Approval: 10/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of group antenatal care model in Ethiopia
Official scientific title Effectiveness of group antenatal care model in improving health literacy and self-efficacy, quality of care experience, and maternity continuum of care utilization at the primary health care delivery sites in northwest Ethiopia
Brief summary describing the background and objectives of the trial Ending preventable maternal and neonatal mortality remains a global and national priorities [1]. Despite the governmental commitments, the annual reduction rates of these mortalities in Ethiopia are very slow as compared to the required reduction rates to reach the maternal mortality ratio (MMR) of 70/100,000 live births and neonatal mortality rate (NMR) of 12/1000 live birth by 2030 [2-4]. This is an alarming sign that Ethiopian government and partners should look for a highly effective and an urgent intervention by far. In this perspective, maternity continuum of care (MCC) utilization is identified to be an effective intervention that can reduce about two-third of maternal and neonatal mortalities. However, the extent of MCC utilization in Ethiopia is very low and it can be improved through boosting client’s health literacy and self-efficacy, and quality of care experience. Therefore, strategies that can boost MCC utilization, health literacy and self-efficacy, and quality of care experience are highly required, and group antenatal care (G-ANC) shows a promising effect in these regards [5-8]. However, there is no evidence effectiveness of G-ANC in these aspects in Ethiopia to date to the investigators’ best knowledge. Moreover, innovative delivery approaches at the primary health care delivery sites are Ethiopian government interest to strengthen the second generation health extension program and to achieve the ambitious targets of the second health sector transformation plan [2, 11]. Thus, we designed the current pragmatic cluster RCT to evaluate effectiveness of group antenatal care model in improving health literacy and self-efficacy, quality of care experience, and maternity continuum of care utlization at the primary health care delivery sites in northwest Ethiopia, 2022-2023.
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 Education /Training
Anticipated trial start date 15/04/2022
Actual trial start date
Anticipated date of last follow up 15/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 456
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group Antenatal Care Model The frequency of Group ANC model will be depend on that of the national standard ANC. To date, the national ANC model in Ethiopia is focused ANC in which a minimum of 4 visits are recommended for the pregnant women with no complications. However, there is a plan and preparation nationally to indorse and implement the WHO Eight ANC contact model. Thus, if the standard ANC model is changed in the process, the frequency of Group ANC model in the intervention arm will be updated too. The follow up will stay from time of participant requirement (before or at 16 weeks of gestation) to time of end line data collection (3-14 days of postpartum) G-ANC model is an innovative service delivery approach which puts women at the centre of service provision and aims to improve women’s access, engagement, and satisfaction. G-ANC uses effective communication and support function as a key mechanism to improve uptake of maternity health services thereby decreasing preventable maternal and perinatal mortalities and morbidities. In G-ANC, women of similar gestational age, residence and language are organized into similar cohorts (about 5-15 members) that visit a health facility at the same time; attend ANC together throughout their pregnancies; actively engage in their own care; freely interact with the health care provider and amongst themselves; and bond with one another, seek moral support, exchange knowledge, share concerns and thereby forming a unique support system. In G-ANC, there are three basic elements. These are clinical assessment and cares provided for all routine antenatal care services; participatory and facilitated learning; and peer support. Basically, G-ANC model uses stable group members and facilitators; sets plan and purpose for each session while remaining responsive to group interests; applies group processes that use nonhierarchical, client-centered and participatory methods; considers widest range of cares possible within the group setting; focuses on promotion for empowerment, self-efficacy, reflection, and planned action through specific activities; and facilitates peer-to-peer learning, support, group identity, and cohesion 228
Control Group Standard Antenatal care model As per the national protocol Similar with the Intervention arm Pregnant women will receive standard antenatal care (i.e., one-on one approach) 228 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a) Pregnant women with 16 weeks gestation or below at time of recruitment b) Pregnant women who voluntarily choose to attend ANC follow up in group approach c)Pregnant women who have no plan to leave the respective residence at least for next one year Those pregnant women whose gestational age remains unknown with all available techniques of estimation of gestational age. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 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
Gondar, Amhara national regional state, northwest Ethiopia Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Health literacy and self-efficacy, Quality of care experience, and maternity continuum of care utilization All outcomes will be mesured after 48 hours of postpartum and within 2 weeks of postaprtum
Secondary Outcome Intention to adhere to exclusive breastfeeding and intention to use postpartum family planning All outcomes will be mesured after 48 hours of postpartum and within 2 weeks of postaprtum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Four districts which are free from any security issues in Central Gondar Zone Central Gondar zone, Amhara regional state, northwest Ethiopia Gondar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
International Institute for Primary Health Care Ethiopia Addis Ababa Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The International Institute for Primary Health Care Ethiopia Addis Ababa Addis Ababa Ethiopia Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhabaw Shumye Mihret muhabawshumye@gmail.com +251918473798 Gondar, Amhara regional state, northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Assistant professor of Clinical Midwifery at University of Gondar
Role Name Email Phone Street address
Public Enquiries Kassahun Alemu Kassalemu@gmail.com +251911752466 Gondar, Amhara regional state, northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Professor of Epidemiology and Public Helath at University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Chernet Baye bayechernet@gmail.com +251943293818 Gondar, Amhara regional state, northwest Ethiopia
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia Assistant professor of Gynecology and Obsterics at University of Gondar Specialized comprehnsive hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will be provided immediately after data collection is completed (i.e., within 10 to 12 months onward Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD will be shared after 10 to 12 months onward Only anonymized data will be shared
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