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.: PACTR201604001582128 Date of Approval: 12/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the impact of the Helping Mothers Survive ¿ Bleeding After Birth (HMS ¿ BAB) training programme in Tanzania and Uganda
Official scientific title Evaluating the impact of the Helping Mothers Survive ¿ Bleeding After Birth (HMS ¿ BAB) training programme in Tanzania and Uganda. A cluster randomized trial.
Brief summary describing the background and objectives of the trial Haemorrhage continues to be a major cause of death of mothers giving birth in sub-Saharan Africa, including in Tanzania and Uganda. Many effective interventions are available to prevent and treat post-partum haemorrhage. However, training and skills of health providers attending births remain insufficient. The study aims to assess the impact of a 1-day competency-based training ¿Helping Mothers Survive: Bleeding after Birth¿ on morbidity due to post-partum haemorrhage. The study will use a cluster randomized two-arm trial to assess changes in severe morbidity (near-miss) due to post-partum haemorrhage. The study will include 18-20 clusters (health districts) which are randomized to either receiving or not receiving the training in each of the two intervention countries, Tanzania and Uganda using restricted randomization. We will use an adapted version of the WHO near-miss classification to estimate severe morbidity due to haemorrhage. The study aims to inform policy makers on the usefulness of scaling up this training module in low-resource settings.
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 01/11/2016
Actual trial start date 01/02/2016
Anticipated date of last follow up 30/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 48000
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
Parallel: different groups receive different interventions at same time during study Randomised stratified randomisation The stratified randomisation of districts was done by out trial statistician and then communicated to the participating district authorities Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Helping Mother Survive 1-day competency-based training 1 day followed by 6 x peer practise 2 months peer practise Training intervention in facilities 12000
Control Group routine care as provided by facilities 12000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Typical rural districts with at least one hospital and several health centres Consenting to participate Other training or support mechanisms to improve perinatal care for post-partum bleeding 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 06/10/2014 MUHAS
Ethics Committee Address
Street address City Postal code Country
Box 65001 Dar-es-Salaam Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Haemorrhage near-miss cases among all women who delivered in the facility Continious Feb 2016 to Oct 2016 in Tanzania Continious Sept 2016 to April 2017 in Uganda
Primary Outcome ¿ Haemorrhage near-miss cases among women who suffered PPH in health facility delivery-service Continious Feb 2016 to Oct 2016 in Tanzania Continious Sept 2016 to April 2017 in Uganda
Primary Outcome ¿ Near-miss cases among all women who delivered in the facility Continious Feb 2016 to Oct 2016 in Tanzania Continious Sept 2016 to April 2017 in Uganda
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AUGO Anatomy dept, Makerere Compound Kampala Uganda
AGOTA P.O.Box 65117 Da-es-Salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The Laerdal Foundation for Acute Medicine Box 377 Stavanger 4002 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FIGO 10 THeed Street United Kingdom SE1 8ST United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Claudia Hanson, Karolinska Institutet Tomtebodavägen 18A Stockholm 17177 Sweden
Dinah Amongin Box 11966 Kampala Uganda
Fadhlun Alwy Box 65117 Dar-es-Salaam United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Claudia Hanson claudia.hanson@ki.se 0046 734043567 Tomtebodavägen 18A
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden Researcher
Role Name Email Phone Street address
Public Enquiries Jessica Morris jessica@figo.org +44 20 7928 1166 10 Theed Street
City Postal code Country Position/Affiliation
London SE1 8ST United Kingdom Project Manager
Role Name Email Phone Street address
Scientific Enquiries Claudia Hanson claudia.hanson@ki.se 0046734043567 Tomtebodavägen 18A
City Postal code Country Position/Affiliation
Stockholm 17177 Sweden Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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