PMID- 35488317
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230322
IS  - 2055-5784 (Print)
IS  - 2055-5784 (Electronic)
IS  - 2055-5784 (Linking)
VI  - 8
IP  - 1
DP  - 2022 Apr 29
TI  - Antenatal couples' counselling in Uganda (ACCU): study protocol for a randomised 
      controlled feasibility trial.
PG  - 97
LID - 10.1186/s40814-022-01049-5 [doi]
LID - 97
AB  - 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.
CI  - (c) 2022. The Author(s).
FAU - Mubangizi, Vincent
AU  - Mubangizi V
AUID- ORCID: 0000-0003-4636-7847
AD  - Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda. 
      vmubangizi@must.ac.ug.
FAU - McGrath, Nuala
AU  - McGrath N
AD  - School of Primary Care, Population Sciences and Medical Education, Faculty of 
      Medicine, University of Southampton, Southampton, UK.
AD  - Department of Social Statistics and Demography, Faculty of Social Sciences, 
      University of Southampton, Southampton, UK.
FAU - Kabakyenga, Jerome Kahuma
AU  - Kabakyenga JK
AD  - Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda.
FAU - Muller, Ingrid
AU  - Muller I
AD  - School of Primary Care, Population Sciences and Medical Education, Faculty of 
      Medicine, University of Southampton, Southampton, UK.
FAU - Stuart, Beth L
AU  - Stuart BL
AD  - School of Primary Care, Population Sciences and Medical Education, Faculty of 
      Medicine, University of Southampton, Southampton, UK.
FAU - Raftery, James P
AU  - Raftery JP
AD  - School of Primary Care, Population Sciences and Medical Education, Faculty of 
      Medicine, University of Southampton, Southampton, UK.
FAU - Natukunda, Sylvia
AU  - Natukunda S
AD  - Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda.
FAU - Ngonzi, Joseph
AU  - Ngonzi J
AD  - Mbarara University of Science and Technology, P.O. Box 1410, Mbarara, Uganda.
FAU - Goodhart, Clare
AU  - Goodhart C
AD  - Royal College of General Practioners, London, UK.
FAU - Willcox, Merlin Luke
AU  - Willcox ML
AD  - School of Primary Care, Population Sciences and Medical Education, Faculty of 
      Medicine, University of Southampton, Southampton, UK.
LA  - eng
GR  - MC_PC_MR/R024693/1/MRC_/Medical Research Council/United Kingdom
GR  - MR/T003618/1/MRC_/Medical Research Council/United Kingdom
GR  - MT/T003618/1/Medical Research Council, UK/
PT  - Journal Article
DEP - 20220429
PL  - England
TA  - Pilot Feasibility Stud
JT  - Pilot and feasibility studies
JID - 101676536
PMC - PMC9051788
OTO - NOTNLM
OT  - Antenatal
OT  - Birth planning
OT  - Birth preparedness
OT  - Contraception
OT  - Couples counselling
OT  - Family planning
OT  - Film
OT  - Postpartum
OT  - Uganda
COIS- The authors declare that they have no competing interests.
EDAT- 2022/05/01 06:00
MHDA- 2022/05/01 06:01
PMCR- 2022/04/29
CRDT- 2022/04/30 00:00
PHST- 2021/09/27 00:00 [received]
PHST- 2022/04/14 00:00 [accepted]
PHST- 2022/04/30 00:00 [entrez]
PHST- 2022/05/01 06:00 [pubmed]
PHST- 2022/05/01 06:01 [medline]
PHST- 2022/04/29 00:00 [pmc-release]
AID - 10.1186/s40814-022-01049-5 [pii]
AID - 1049 [pii]
AID - 10.1186/s40814-022-01049-5 [doi]
PST - epublish
SO  - Pilot Feasibility Stud. 2022 Apr 29;8(1):97. doi: 10.1186/s40814-022-01049-5.