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.: PACTR202006793783148 Date of Approval: 17/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ALERT – Action Leveraging Evidence to reduce perinatal Mortality and morbidity in Sub-Saharan Africa
Official scientific title ALERT – Action Leveraging Evidence to reduce perinatal Mortality and morbidity in Sub-Saharan Africa
Brief summary describing the background and objectives of the trial Perinatal mortality (late fetal death at 28 weeks or more and early neonatal death under the age of seven days) remains high in sub-Saharan Africa, where up to 50 % of all births of the region take place. We aim to develop and evaluate a multifaceted health system approach with the aim to strengthen the implementation of evidence-based interventions and responsive care in sub-Saharan Africa hospitals. This approach will include end-user participation through narratives of women, families and midwifery providers in order to understand what works and under which conditions. Competency-based training and quality improvement (supported by data from a clinical perinatal e-registry) will also be provided as well as empowerment and leadership mentoring of maternity unit leaders. We will evaluate the intervention through a stepped-wedge design, the primary outcome being in-facility perinatal (stillbirths and early neonatal) mortality. Our nested realist process evaluation will help to understand what works, for whom and under which condition. An economic evaluation will report on scalability and costs. The research project is financed by EU https://cordis.europa.eu/project/id/847824
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ALERT
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Improvement intervention composed of end-user participation, training, quality improvement and mentoring
Anticipated trial start date 01/01/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 29/02/2024
Anticipated target sample size (number of participants) 144000
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://alert.ki.se/dissemination-materials/
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 Simple randomization using a randomization table created by a computer software program 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 ALERT End-user participation, 4 training sessions and continious mentoring and quality improvement 30 months • End-user participation using narratives of women, families and midwifery providers for co-designed competency-based training • Quality improvement empowered by data from a perinatal e-registry • Empowerment and leadership mentoring of hospital maternity unit leaders • Coordination and accountability meetings 60000
Control Group standard care standard care 30 months standard care 60000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all women giving birth in selected hospitals (reproductive age) Their neonates (both sexes) after being born Hospitals selected based on the criteria: i) with an approximate minimum caseload of 3,000 deliveries per year ii) that offer caesarean section and blood transfusion services iii) that are preferably located in rural areas iv) present a mix of typical rural but also private-not-for-profit (faith-based) hospitals Women in reproductive age admitted after giving birth Adolescent: 13 Year-18 Year,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
No 31/03/2020 Regional Ethics board Sweden
Ethics Committee Address
Street address City Postal code Country
Ethikprovningsmyndigheten, box 2110 Uppsala 75002 Sweden
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 29/06/2020 Universtiy of Atnwerpen
Ethics Committee Address
Street address City Postal code Country
3 Eikenstraat Antwerpen Antwerpen 2650 Belgium
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 20/07/2020 Comite National D Ethique Pour la Recherce en Sante
Ethics Committee Address
Street address City Postal code Country
Not available Cotonou 08BP882 Benin
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 07/07/2020 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Private Bag 360 Chichiri Blantyre 0000 Malawi
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 05/05/2020 Muhimbili University of Health and Allied Sciences
Ethics Committee Address
Street address City Postal code Country
PO Box 65001 Dar Es Salaam 0000 Tanzania
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 04/08/2020 Ministry Health Community Development Gender Elderly and Children
Ethics Committee Address
Street address City Postal code Country
PO Box 743 Dar Es Salaam 0000 Tanzania
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 21/03/2020 Institute for Educational Development East Africa Aga Khan University
Ethics Committee Address
Street address City Postal code Country
344 Urambo Street Dar Es Salaam 0000 Tanzania
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 09/12/2020 Higher Degrees Research and Ethics Committee College of Health Sciences Makerere University
Ethics Committee Address
Street address City Postal code Country
PO Box 7072 Kampala 0000 Uganda
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 08/06/2020 Higher Degrees Research and Ethics Committee College of Health Sciences Makerere University
Ethics Committee Address
Street address City Postal code Country
PO Box 7072 Kampala 0000 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fresh / intrapartum stillbirth rate defined as number of fresh stillbirths of at least 1000g expressed per 1,000 live and stillbirths continued, month 1 to 30 of trial
Primary Outcome In-facility early perinatal mortality defined as number of fresh stillbirths (as above) and up-to discharge neonatal deaths per 1,000 live and stillbirths (composite indicator) continued, month 1 to 30 of trial
Secondary Outcome Hypoxic-ischaemic event rate continued, month 1 to 30 of trial
Secondary Outcome Neonatal seizures continued, month 1 to 30 of trial
Secondary Outcome Caesarean section rate (%) continued, month 1 to 30 of trial
Secondary Outcome Severe maternal morbidity continued, month 1 to 30 of trial
Secondary Outcome Responsiveness (%) month 1, 7, 13, 19, and 25 of the trial
Secondary Outcome Mistreatment (%) month 1, 7, 13, 19, and 25 of the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherche en Reproduction Humaine et an demopgraphie Ahouanleko Cotonou Benin
College of Medicine Zomba Bantyre Malawi
Aga Khan University Ufukoni Rd Dar es Salaam United Republic of Tanzania
Muhimbili University of Health and Allied Sciences United Nations Road Dar es Salaam Tanzania
Makerere University Main Campus Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
European Commission Directorate of Research Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Karolinska Institutet Tomtebodavagan Stockholm 17177 Sweden University
COLLABORATORS
Name Street address City Postal code Country
Claudia Hanson Tomtebodavaegen Stockkolm 17177 Sweden
Lenka Benova Nationalestraat 155 Antwerpen 2000 Belgium
Mechthild Gross Carl-Neuberg-Strasse 1 Hannover 30625 Germany
Jean Paul Doussou Av. Jean-Paul II Cotonou Benin
Effie Chipeta Malawi College of Medicine Blantyre Malawi
Andrea Pembe P.O. Box 65001 Dar es Salaam United Republic of Tanzania
Kidanto Hussein Urambo Street 125 Dar es Salaam United Republic of Tanzania
Peter Waiswa Main Campus, Makerere University Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Claudia Hanson claudia.hanson@ki.se +46734043567 Tomtebodavaegen
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Kristi Sidney Annerstedt kristi.sidney@ki.se +467079202081 Tomtebodavgen 18A
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden Postdoctoral researcher
Role Name Email Phone Street address
Scientific Enquiries Claudia Hanson claudia.hanson@ki.se +46734043567 Tomtebodavgen 18A
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden Senior lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We plan to share on Zenodo repository Informed Consent Form,Study Protocol We are in the process of preparing the full protocol. We aim to submit by September or October Trial protocol is published https://pubmed.ncbi.nlm.nih.gov/34895216/ We will publish open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pubmed.ncbi.nlm.nih.gov/34895216/ 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 14/12/2024 we were delayed because of COVID-19. It took more time to get the data collection running 01 Jul 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/12/2024 The intention to treat data collection was finalised Dec 2023. In three countries we collected data also in January and February as the teams felt they would have an important impact on the hospital 4. However, the ITT analysis remains according to protocol 29 Feb 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/12/2024 we have now finalised the data collection. We included 139,300 births Not yet recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 14/12/2024 preliminary https://alert.ki.se/dissemination-materials/
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 Update of record TRUE, Universtiy of Atnwerpen, 3 Eikenstraat Antwerpen, Antwerpen, 2650, Belgium, , 29 Jun 2020, +3238213000, etisch.comite@uza.be, 11072_13364_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Comite National D Ethique Pour la Recherce en Sante, Not available, Cotonou, 08BP882, Benin, , 20 Jul 2020, +22921332178, sante.infos@gouv.bj, 11072_13365_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, College of Medicine Research and Ethics Committee, Private Bag 360 Chichiri, Blantyre, 0000, Malawi, , 07 Jul 2020, 01871911, ethics@umalawi.ma, 11072_13366_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Muhimbili University of Health and Allied Sciences, PO Box 65001, Dar Es Salaam, 0000, Tanzania, , 05 May 2020, +22522212489, drp@muhas.ac.tz, 11072_13367_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Ministry Health Community Development Gender Elderly and Children, PO Box 743, Dar Es Salaam, 0000, Tanzania, , 04 Aug 2020, +255222121400, nimrethics@gmail.com, 11072_13368_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Institute for Educational Development East Africa Aga Khan University, 344 Urambo Street, Dar Es Salaam, 0000, Tanzania, , 21 Mar 2020, +255222152293, iedea@aku.edu, 11072_13369_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Higher Degrees Research and Ethics Committee College of Health Sciences Makerere University, PO Box 7072, Kampala, 0000, Uganda, , 09 Dec 2020, +25641532207, Ethics@musph.ac.ug, 11072_13370_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2021 update TRUE, Higher Degrees Research and Ethics Committee College of Health Sciences Makerere University, PO Box 7072, Kampala, 0000, Uganda, , 08 Jun 2020, +256414532207, ethics@musph.ac.ug, 11072_13371_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 14/12/2024 publication is out We are in the process of preparing the full protocol. We aim to submit by September or October We are in the process of preparing the full protocol. We aim to submit by September or October Trial protocol is published https://pubmed.ncbi.nlm.nih.gov/34895216/
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 14/12/2024 published https://pubmed.ncbi.nlm.nih.gov/34895216/