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.: PACTR202402782261294 Date of Approval: 05/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cluster Randomized Trial to improve maternal and newborn health through capacity building interventions to community health workers and other resources in Sidama Regional State Ethiopia
Official scientific title Community-based cluster randomized trial to improve care and care seeking during pregnancy, childbirth, and postnatal period through improving the capacity of community health workers and other community resources in Sidama Reginal State, Ethiopia (SiMaNeH trial):
Brief summary describing the background and objectives of the trial Maternal and newborn mortality and severe morbidity during pregnancy and childbirth are major public health problem in developing countries such as Ethiopia. Access to and continuum of care in the health system quality is highly limited in remote rural communities. However, community resources such as voluntary women support groups (women development army in Ethiopia), religious and political leaders in the villages, and community health workers (Health Extension Workers in Ethiopia) have a potential to contribute to quality improvement through identifying and encouraging early care seeking, encouraging keeping the continuity in the care, referring for care during emergencies to reduce delays and adverse outcomes during pregnancy and childbirth for both the mother and the newborn Interventions aiming at facilitating dialog through participatory learning and action and problem solving within the community to create awareness and response to maternal and newborn problems may unlock the power of community actors. However, so far, several community-based trials target only specific groups and restricted interventions for complex problems that require coordinated actions. As such, the findings are inconclusive and context specific. The objective of this trial is to implement a package of interventions aimed to empower community resource to put coordinated efforts through participatory learning and action approach to improve initiation of care seeking, improve continuity of care from pregnancy through postnatal care to reduce maternal and newborn adverse outcomes. The influential community leaders will work in collaboration with community health workers and make monthly discussion meeting after initial basic training by project staff. The community health workers will receive initial and follow-up trainings on how to effectively coordinate the efforts of other community resource persons and to provide home-based maternal and newborn care during pregnancy, childbirth.
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 01/02/2024
Actual trial start date
Anticipated date of last follow up 28/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 2000
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Package of community empowerment interventions that includes Health extension workers and volunteers two years Health extension workers will receive facilitation and skills trianing. They will facilitate participatory learning and action activities of village community leaders (women support groups and other village community leaders). Women support group will lead participatory leaning and action dialog with pregnant women, reproductive age women, men, and village community leaders to identify problems to pregnant women and newborns in their respected sub-villages. They will identify health problems related to pregnancy, childbirth, and newborns and report to health extension workers for treatment, referrals, and follow-ups. Health extension workers will also receive skills training and provide improved care during antenatal, postnatal, and newborn care through home visit, also emergency help during home delivery.The village community leaders will work in collaboration with women support group and make monthly discussion after initial basic training by project staff and health extension workers. Intervention will improve maternal and newborn care with emphasis on continuum of care from pregnancy to postnatal period. Mothers and family will receive important maternal and newborn health information and help from community system such as emergency transport. 1000
Control Group Routine service from government Routine service the same period of follow-up with intervention group The control clusters follow the routine health service from public health system. Common health systems strengthening government actions will work in both the intervention and control clusters equally. 1000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) all women as they become pregnant in the study villages (intervention and control clusters) 2) Permanent residents of the study nvillage (cluster) 3) Woment who get pregnant during the study period 4) all newborn to mothers included in the study (intervention and control clusters) 1) Women who come to the study cluster temporarly during pregnancy and childbirth Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month 0 Year(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 07/08/2023 Institutional Review Board at College of Medicine and Health Sciences Hawassa University
Ethics Committee Address
Street address City Postal code Country
CMHS, Hawassa university Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in continuum of maternal and newborn care measured interms of completion of recommended pregnancy and childbirth and newborn care 1-Maternal continuum of care measured through reduced dropout from initiation of first antenatal visit until postnatal care 2- the efect of completed/non-completed continuum of care on immediate newborn resuscitation, newborn termal care, breast feeding and immediate referral of sick babies. From a mother is identified as pregnant through completion of postnatal period
Secondary Outcome Neonatal mortality, stillbirth, maternal mortality, severe and life-threatening morbidity to newborns and mothers From the mother was identified as pregnant up until the completion of postnatal care period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alowa ano Shebedino 101 Shebedino 1101 Ethiopia
Dila gumbe Shebedino 102 Shebedino 1102 Ethiopia
Dila Afferara Shebedino 103 Shebedino 1103 Ethiopia
Diramo Afferara Shebedino 1104 Shebedino 1104 Ethiopia
Sadamo Chale Bilate zuria 201 Bilate zuria 1201 Ethiopia
Konsore Haranja Bilate zuria 202 Bilate Zuria 1202 Ethiopia
Shamana Godo Bilate Zuria 203 Bilate zuria 1203 Ethiopia
Gonowa Bulano Bilate zuria 204 Bilate Zuria 1204 Ethiopia
Dila Anole Bilate zuria 205 Bilate zuria 1205 Ethiopia
Galo argiso Hawassa zuria 301 Hawassa zuria 1301 Ethiopia
Jara hinesa Hawassa zuria 302 Hawassa zuria 1302 Ethiopia
Jara Dado Hawassa zuria 303 Hawassa zuria 1303 Ethiopia
Doyo chale Hawassa zuria 304 Hawassa zuria 1304 Ethiopia
Jara Damuwa Hawassa zuria 305 Hawassa zuria 1305 Ethiopia
Tankaka Hawassa zuria 306 Hawassa zuria 1306 Ethiopia
Alawo Arke Boricha 401 Boricha 1401 Ethiopia
Konsore chefe Boricha 402 Boricha 1402 Ethiopia
Alawo siso Boricha 403 Boricha 1403 Ethiopia
Bonoya mireda Shebedino 105 Shebedino 1105 Ethiopia
Hanja chefe Boricha 404 Boricha 1404 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Southern Ethiopia Universities network for Public Health SENUPH II Hawassa University referral hospital Hawassa 1560 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hawassa University Hawassa main road str Hawassa 1560 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Centre for International Health University of Bergen Aastadsveien 21 Bergen 5009 Norway
Western Norway University of Applied Sciences Inndalsveien 28 Bergen 5020 Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Achamyelesh Gebretsadik agtsadik@gmail.com +251911303128 Hawassa referal hospital
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Associate Professor project coordinator PI
Role Name Email Phone Street address
Scientific Enquiries Achamyelesh Gebretsadik agtsadik@gmail.com +2519303128 Hawassa referal hospital
City Postal code Country Position/Affiliation
Hawassa 1560 Ethiopia Associate Professor Project coordinator
Role Name Email Phone Street address
Public Enquiries Taye Gari tayegari@yahoo.com +251926276598 Hawassa referral Hospital
City Postal code Country Position/Affiliation
Hawassa Ethiopia SENUPH coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes With reference to our Individual Patient Data (IPD) Sharing Declaration. We fully endorse the WHO's guidelines for openness and scientific cooperation. Individual trial participant data that have been de-identified will be provided upon request, pending ethical and legal approval. Sharing IPD, in our opinion, will improve the validity and repeatability of our study findings and further the body of knowledge in our area. This will be done within 12 months of the study completion date Statistical Analysis Plan,Study Protocol Beginning 12 months of completion of the study and ending 24 months following after sharing Investigators who request access IPD should have IPD approved protocol of use an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable now 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