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Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial

BACKGROUND: Postpartum haemorrhage complicates approximately 10% of all deliveries and contributes to at least a quarter of all maternal deaths worldwide. The competency-based Helping Mothers Survive Bleeding after Birth (HMS BAB) training was developed to support evidence-based management of postpa...

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Autores principales: Hanson, Claudia, Pembe, Andrea B., Alwy, Fadhlun, Atuhairwe, Susan, Leshabari, Sebalda, Morris, Jessica, Kaharuza, Frank, Marrone, Gaetano
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501356/
https://www.ncbi.nlm.nih.gov/pubmed/28683806
http://dx.doi.org/10.1186/s13063-017-2056-7
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author Hanson, Claudia
Pembe, Andrea B.
Alwy, Fadhlun
Atuhairwe, Susan
Leshabari, Sebalda
Morris, Jessica
Kaharuza, Frank
Marrone, Gaetano
author_facet Hanson, Claudia
Pembe, Andrea B.
Alwy, Fadhlun
Atuhairwe, Susan
Leshabari, Sebalda
Morris, Jessica
Kaharuza, Frank
Marrone, Gaetano
author_sort Hanson, Claudia
collection PubMed
description BACKGROUND: Postpartum haemorrhage complicates approximately 10% of all deliveries and contributes to at least a quarter of all maternal deaths worldwide. The competency-based Helping Mothers Survive Bleeding after Birth (HMS BAB) training was developed to support evidence-based management of postpartum haemorrhage. This one-day training includes low-cost MamaNatalie® birthing simulators and addresses both prevention and first-line treatment of haemorrhage. While evidence is accumulating that the training improves health provider’s knowledge, skills and confidence, evidence is missing as to whether this translates into improved practices and reduced maternal morbidity and mortality. This cluster-randomised trial aims to assess whether this training package — involving a one-day competency-based HMS BAB in-facility training provided by certified trainers followed by 8 weeks of in-service peer-based practice — has an effect on the occurrence of haemorrhage-related morbidity and mortality. METHODS/DESIGN: In Tanzania and Uganda we randomise 20 and 18 districts (clusters) respectively, with half receiving the training intervention. We use unblinded matched-pair randomisation to balance district health system characteristics and the main outcome, which is in-facility severe morbidity due to haemorrhage defined by the World Health Organizationation-promoted disease and management-based near-miss criteria. Data are collected continuously in the intervention and comparison districts throughout the 6-month baseline and the 9-month intervention phase, which commences after the training intervention. Trained facility midwives or clinicians review severe maternal complications to identify near misses on a daily basis. They abstract the case information from case notes and enter it onto programmed tablets where it is uploaded. Intention-to-treat analysis will be used, taking the matched design into consideration using paired t test statistics to compare the outcomes between the intervention and comparison districts. We also assess the impact pathway from the effects of the training on the health provider’s skills, care and interventions and health system readiness. DISCUSSION: This trial aims to generate evidence on the effect and limitations of this well-designed training package supported by birthing simulations. While the lack of blinding of participants and data collectors provides an inevitable limitation of this trial, the additional evaluation along the pathway of implementation will provide solid evidence on the effects of this HMS BAB training package. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR201604001582128. Registered on 12 April 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2056-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-55013562017-07-10 Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial Hanson, Claudia Pembe, Andrea B. Alwy, Fadhlun Atuhairwe, Susan Leshabari, Sebalda Morris, Jessica Kaharuza, Frank Marrone, Gaetano Trials Study Protocol BACKGROUND: Postpartum haemorrhage complicates approximately 10% of all deliveries and contributes to at least a quarter of all maternal deaths worldwide. The competency-based Helping Mothers Survive Bleeding after Birth (HMS BAB) training was developed to support evidence-based management of postpartum haemorrhage. This one-day training includes low-cost MamaNatalie® birthing simulators and addresses both prevention and first-line treatment of haemorrhage. While evidence is accumulating that the training improves health provider’s knowledge, skills and confidence, evidence is missing as to whether this translates into improved practices and reduced maternal morbidity and mortality. This cluster-randomised trial aims to assess whether this training package — involving a one-day competency-based HMS BAB in-facility training provided by certified trainers followed by 8 weeks of in-service peer-based practice — has an effect on the occurrence of haemorrhage-related morbidity and mortality. METHODS/DESIGN: In Tanzania and Uganda we randomise 20 and 18 districts (clusters) respectively, with half receiving the training intervention. We use unblinded matched-pair randomisation to balance district health system characteristics and the main outcome, which is in-facility severe morbidity due to haemorrhage defined by the World Health Organizationation-promoted disease and management-based near-miss criteria. Data are collected continuously in the intervention and comparison districts throughout the 6-month baseline and the 9-month intervention phase, which commences after the training intervention. Trained facility midwives or clinicians review severe maternal complications to identify near misses on a daily basis. They abstract the case information from case notes and enter it onto programmed tablets where it is uploaded. Intention-to-treat analysis will be used, taking the matched design into consideration using paired t test statistics to compare the outcomes between the intervention and comparison districts. We also assess the impact pathway from the effects of the training on the health provider’s skills, care and interventions and health system readiness. DISCUSSION: This trial aims to generate evidence on the effect and limitations of this well-designed training package supported by birthing simulations. While the lack of blinding of participants and data collectors provides an inevitable limitation of this trial, the additional evaluation along the pathway of implementation will provide solid evidence on the effects of this HMS BAB training package. TRIAL REGISTRATION: Pan African Clinical Trials Registry, PACTR201604001582128. Registered on 12 April 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2056-7) contains supplementary material, which is available to authorized users. BioMed Central 2017-07-06 /pmc/articles/PMC5501356/ /pubmed/28683806 http://dx.doi.org/10.1186/s13063-017-2056-7 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Hanson, Claudia
Pembe, Andrea B.
Alwy, Fadhlun
Atuhairwe, Susan
Leshabari, Sebalda
Morris, Jessica
Kaharuza, Frank
Marrone, Gaetano
Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title_full Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title_fullStr Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title_full_unstemmed Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title_short Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial
title_sort evaluating the effect of the helping mothers survive bleeding after birth (hms bab) training in tanzania and uganda: study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501356/
https://www.ncbi.nlm.nih.gov/pubmed/28683806
http://dx.doi.org/10.1186/s13063-017-2056-7
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