Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial
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 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.
Antenatal, Birth planning, Birth preparedness, Contraception, Couples counselling, Family planning, Film, Postpartum, Uganda
Mubangizi, Vincent
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McGrath, Nuala
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Kabakyenga, Jerome Kahuma
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Muller, Ingrid
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Stuart, Beth L.
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Raftery, James P.
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Natukunda, Sylvia
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Ngonzi, Joseph
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Goodhart, Clare
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Willcox, Merlin Luke
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29 April 2022
Mubangizi, Vincent
97527a1e-b030-477b-9421-5c71da6c0530
McGrath, Nuala
b75c0232-24ec-443f-93a9-69e9e12dc961
Kabakyenga, Jerome Kahuma
b0dd6715-9e5c-44ab-90ff-47f22a024112
Muller, Ingrid
2569bf42-51bd-40da-bbfd-dd4dbbd62cad
Stuart, Beth L.
626862fc-892b-4f6d-9cbb-7a8d7172b209
Raftery, James P.
27c2661d-6c4f-448a-bf36-9a89ec72bd6b
Natukunda, Sylvia
9e40812a-6f22-4c02-8f2c-72fee77aefb5
Ngonzi, Joseph
be734816-acd0-4068-b66c-2e8b238ca996
Goodhart, Clare
6609457f-bc4a-4680-a84c-32fd3f874c57
Willcox, Merlin Luke
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Mubangizi, Vincent, McGrath, Nuala, Kabakyenga, Jerome Kahuma, Muller, Ingrid, Stuart, Beth L., Raftery, James P., Natukunda, Sylvia, Ngonzi, Joseph, Goodhart, Clare and Willcox, Merlin Luke
(2022)
Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised controlled feasibility trial.
Pilot and Feasibility Studies, 8, [97].
(doi:10.1186/s40814-022-01049-5).
Abstract
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.
Text
s40814-022-01049-5
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More information
Accepted/In Press date: 14 April 2022
Published date: 29 April 2022
Additional Information:
Funding Information:
We are grateful for the financial support from the Medical Research Council, UK.
Funding Information:
The “Antenatal Couples Counselling in Uganda” project is funded by the Medical Research Council, UK, under reference number MT/T003618/1. The sponsor is the University of Southampton, University Road, Southampton, Highfield, SO17 1BJ, UK. Both the funding body and the sponsor have not had any role in the design of the study and will not have any role in the collection, management analysis, interpretation of the data, writing of the manuscript and decision to submit the report for publication.
Publisher Copyright:
© 2022, The Author(s).
Keywords:
Antenatal, Birth planning, Birth preparedness, Contraception, Couples counselling, Family planning, Film, Postpartum, Uganda
Identifiers
Local EPrints ID: 473949
URI: http://eprints.soton.ac.uk/id/eprint/473949
ISSN: 2055-5784
PURE UUID: d3b14b50-6c38-4aaf-a9e3-b2fb66ac1e38
Catalogue record
Date deposited: 06 Feb 2023 17:38
Last modified: 17 Mar 2024 03:45
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Contributors
Author:
Vincent Mubangizi
Author:
Jerome Kahuma Kabakyenga
Author:
Sylvia Natukunda
Author:
Joseph Ngonzi
Author:
Clare Goodhart
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