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Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial

BACKGROUND: Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many wome...

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Autores principales: Mubangizi, Vincent, McGrath, Nuala, Kabakyenga, Jerome Kahuma, Muller, Ingrid, Stuart, Beth L., Raftery, James P., Natukunda, Sylvia, Ngonzi, Joseph, Goodhart, Clare, Willcox, Merlin Luke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9051788/
https://www.ncbi.nlm.nih.gov/pubmed/35488317
http://dx.doi.org/10.1186/s40814-022-01049-5
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author Mubangizi, Vincent
McGrath, Nuala
Kabakyenga, Jerome Kahuma
Muller, Ingrid
Stuart, Beth L.
Raftery, James P.
Natukunda, Sylvia
Ngonzi, Joseph
Goodhart, Clare
Willcox, Merlin Luke
author_facet Mubangizi, Vincent
McGrath, Nuala
Kabakyenga, Jerome Kahuma
Muller, Ingrid
Stuart, Beth L.
Raftery, James P.
Natukunda, Sylvia
Ngonzi, Joseph
Goodhart, Clare
Willcox, Merlin Luke
author_sort Mubangizi, Vincent
collection PubMed
description BACKGROUND: Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda. METHODS: This is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone. DISCUSSION: This intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples’ counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202102794681952. Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01049-5.
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spelling pubmed-90517882022-04-29 Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial Mubangizi, Vincent McGrath, Nuala Kabakyenga, Jerome Kahuma Muller, Ingrid Stuart, Beth L. Raftery, James P. Natukunda, Sylvia Ngonzi, Joseph Goodhart, Clare Willcox, Merlin Luke Pilot Feasibility Stud Study Protocol BACKGROUND: Common avoidable factors leading to maternal, perinatal and neonatal deaths include lack of birth planning (and delivery in an inappropriate place) and unmet need for contraception. Progress has been slow because routine antenatal care has focused only on women. Yet, in Uganda, many women first want the approval of their husbands. The World Health Organization recommends postpartum family planning (PPFP) as a critical component of health care. The aim of this trial is to test the feasibility of recruiting and retaining participants in a trial of a complex community-based intervention to provide counselling to antenatal couples in Uganda. METHODS: This is a two-group, non-blinded cluster-randomised controlled feasibility trial of a complex intervention. Primary health centres in Uganda will be randomised to receive the intervention or usual care provided by the Ministry of Health. The intervention consists of training village health teams to provide basic counselling to couples at home, encouraging men to accompany their wives to an antenatal clinic, and secondly of training health workers to provide information and counselling to couples at antenatal clinics, to facilitate shared decision-making on the most appropriate place of delivery, and postpartum contraception. We aim to recruit 2 health centres in each arm, each with 10 village health teams, each of whom will aim to recruit 35 pregnant women (a total of 700 women per arm). The village health teams will follow up and collect data on pregnant women in the community up to 12 months after delivery and will directly enter the data using the COSMOS software on a smartphone. DISCUSSION: This intervention addresses two key avoidable factors in maternal, perinatal and neonatal deaths (lack of family planning and inappropriate place of delivery). Determining the acceptability and feasibility of antenatal couples’ counselling in this study will inform the design of a fully randomised controlled clinical trial. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding to conduct a fully powered trial of the complex intervention for improving uptake of birth planning and postpartum family planning in Uganda. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202102794681952. Approved on 10 February 2021. ISRCTN Registry ISRCTN97229911. Registered on 23 September 2021 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01049-5. BioMed Central 2022-04-29 /pmc/articles/PMC9051788/ /pubmed/35488317 http://dx.doi.org/10.1186/s40814-022-01049-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Mubangizi, Vincent
McGrath, Nuala
Kabakyenga, Jerome Kahuma
Muller, Ingrid
Stuart, Beth L.
Raftery, James P.
Natukunda, Sylvia
Ngonzi, Joseph
Goodhart, Clare
Willcox, Merlin Luke
Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title_full Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title_fullStr Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title_full_unstemmed Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title_short Antenatal couples’ counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
title_sort antenatal couples’ counselling in uganda (accu): study protocol for a randomised controlled feasibility trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9051788/
https://www.ncbi.nlm.nih.gov/pubmed/35488317
http://dx.doi.org/10.1186/s40814-022-01049-5
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