Improving perinatal bereavement support in Kenya and Uganda
| ISRCTN | ISRCTN10863496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10863496 |
| Secondary identifying numbers | LSTM 23-013 |
- Submission date
- 28/11/2023
- Registration date
- 08/12/2023
- Last edited
- 09/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
The death of a baby before, during or soon after birth, termed stillbirth or neonatal death, is amongst the most traumatic of life events for parents. The overwhelming majority of stillbirths and neonatal deaths happen in low- and middle-income countries, with sub-Saharan Africa and South Asia accounting for around 75% of the global total. The death of a baby has long-lasting impacts on parents, greatly increasing the risk of poor mental and physical health and family breakdown, which has broad-ranging negative effects on wider society. When a baby dies, having good care and support from health workers in the hours and days surrounding the death has a positive effect in helping mothers and fathers cope, and adjust to the loss. However, in many countries parents do not always get good enough care or support after their baby dies. Finding better ways to support parents after the death of a baby is recognised by policymakers as a priority for research.
The NIHR Global Health Research Unit, a partnership between researchers in Africa, South Asia and the UK working with local experts and bereaved parents in Kenya and Uganda has developed changes to care, known as ‘interventions’ to improve support for parents. Previous studies have demonstrated that these interventions can be put into practice and that it would be possible to conduct further research to see whether they improve care and outcomes for women whose baby has died, and their families. In this study, the researchers in Kenya and Uganda, working with the UK team will conduct a trial across maternity hospitals in six areas of Kenya and Uganda involving around 800 women whose baby has died.
Who can participate?
Women aged over 16 years, birthed or received in-patient postnatal care in the included facility where the outcome was stillbirth or neonatal death
What does the study involve?
The study intervention includes an educational workshop for midwives, nurses, and doctors, setting up of a group of ‘bereavement champion’ health workers who will help improve care in hospitals and, in some sites, offering women access to peer support after discharge from hospital. All the hospitals will start the research providing the existing care, changes will be introduced after a few weeks or months. It is hoped that these changes will lead to better services and experiences for mothers, fathers, and their families. To know whether this is true, the researchers will assess grief (the natural reaction to loss) in mothers taking part, also their mood and other emotions such as anxiety about 8 weeks after the birth. The study will also look at the resources and cost of the changes and how they are introduced and work in practice.
What are the possible benefits and risks of participating?
The study will demonstrate whether the changes work as intended and provide important information to help with future implementation in similar hospitals and communities.
Where is the study run from?
Liverpool School of Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
June 2023 to June 2025
Who is funding the study?
National Institute of Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Tracey Mills, tracey.mills@lstmed.ac.uk
Contact information
Public, Scientific, Principal Investigator
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 832 1694 |
|---|---|
| tracey.mills@lstmed.ac.uk |
Study information
| Study design | Pragmatic stepped wedge cluster randomized controlled trial with nested sub-study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community, Hospital |
| Study type | Other |
| Scientific title | Evaluation of a multicomponent intervention to improve perinatal bereavement support for women and families after stillbirth and neonatal death in Kenya and Uganda: a pragmatic cluster randomized controlled trial |
| Study hypothesis | The Improving Perinatal Bereavement Support (Kenya and Uganda) trial is a pragmatic multicentre stepped wedge cluster randomised controlled trial with a nested individually randomised two-arm sub-study. This trial will test the hypothesis that the implementation of a co-produced multicomponent intervention, which includes an educational workshop for health workers, the creation of a bereavement champion network and/or access to telephone peer support, will reduce grief intensity for women after a stillbirth or early neonatal death compared with existing care and support in Kenya and Uganda. |
| Ethics approval(s) |
1. Approved 02/05/2023, LSTM Research Ethics Committee (Pembroke Place, Liverpool, L3 5QA, United Kingdom; +44 (0)1517053100; lstmrec@lstmed.ac.uk), ref: 23-013 2. Approved 28/07/2023, Kenyatta National Hospital - University of Nairobi ERC (PO Box 20723, Nairobi, 00202, Kenya; +254 (0)2726300 ext 44102 or +254 (0)799495829; uonknh_erc@uonbi.ac.ke), ref: P519/O6/2023 3. Approved 12/09/2023, Makerere University (PO Box 7072, Kampala, 7072, Uganda; +256 (0)200903786; healthsciences.irb@gmail.com), ref: MAKSHSREC-2023-538 |
| Condition | Perinatal bereavement support |
| Intervention | This trial is a stepped-wedge cluster randomized controlled trial (of six clusters, three in each country), where the order of cross-over from usual care to intervention was determined in advance during a public randomisation process. The public randomisation meeting was conducted on 14/09/2023 via TEAMs simultaneously with LSTM (UK), University of Nairobi (Kenya) and Makerere University (Uganda) and coordinated by the LSTM Global Health Trials Unit (GHTU). Representatives from each study cluster attended with members of the research team. A minimisation approach with random elements was taken to ensure balance in allocation between countries. The country to start the trial first was determined by an independent LSTM staff member drawing a marked ball from an opaque bag labelled with each country initial. In each country, three cluster representatives selected a paper slip marked 1, 2 or 3 from an opaque bag to determine the order each representative would draw their site allocation ball. The first representative then drew a marked ball (numbered 1, 2 and 3) from an opaque bag to determine the position of their site. This was followed by representative 2 and 3 in turn for each country. The draw results were recorded and confirmed with all process participants at the conclusion of the draw. The clusters will cross over from usual care to the intervention phase at 6-weekly intervals with a 6-week cross-over period to allow clusters to prepare for the introduction of the intervention. Women will be recruited to the trial approximately 2 weeks post-birth and will be followed up at 8-12 weeks, so their duration on the trial will be a minimum of 6 weeks (maximum 10 weeks) in total. The nested sub-study will take place in two clusters (one in each country) as determined in the public randomisation process, where women will be invited to take part in the nested sub-study, and if consented, will be individually randomized at study recruitment to usual care or the intervention component, the offer of postnatal telephone peer support until 8 weeks postnatal. Women will remain in the sub-study for 6 weeks (minimum) to 10 weeks (maximum) in total. Participants will be individually randomized in the sub-study by the research assistant via web log-in to REDCap, based on a computer-generated sequence. The main study intervention consists of the Advancing Bereavement Care (ABC) 2-day educational workshop designed for delivery to health workers, plus the Bereavement Champions network, a group of health workers committed to improving perinatal bereavement support for women and families. Following workshop training, Bereavement Champions will stimulate interest and support improvements and behaviour change opportunities. In addition to these components, a nested sub-study will see participants in two clusters (one in each country) individually randomised to usual postnatal and community care or usual care plus the offer of telephone peer support. Peer Supporters will be women who have had previous lived experience of the death of a baby (stillbirth or neonatal death) and have attended a training workshop and completed a peer support agreement. There will be a mixed methods process evaluation study conducted in parallel with the main trial, consisting of observations, interviews and focus groups, and a cost-effectiveness health economic analysis. |
| Intervention type | Mixed |
| Primary outcome measure | Maternal grief intensity measured using a Kiswahili or Luganda version of the Perinatal Grief Intensity Scale (PGIS) at 8-12 weeks after birth |
| Secondary outcome measures | 4. Psychological and social secondary outcomes include: 4.1. Maternal anxiety measured using the Generalised Anxiety Disorder 7-item scale (GAD-7) at 8-12 weeks after birth 4.2. Maternal postpartum depression measured using the Edinburgh Postnatal Depression Scale (EPDS) at 8-12 weeks after birth 4.3. Diagnosis and treatment of maternal mental health conditions measured using the maternal self-report method at 8-12 weeks after birth 4.4. Maternal perception of social support measured using the Multidimensional Scale of Perceived Social Support (MPSS) at 8-12 weeks after birth Health economics secondary outcome: Cost-effectiveness of the intervention measured using cost consequence framework at the study end Process evaluation secondary outcomes include: 1. Fidelity, ‘dose’, reach and adaptations made in the study context measured using intervention logs, observation checklists and peer support logs collated during the course of the trial 2. Women’s, families’, health workers’ and service managers’ views and experiences of the intervention and usual care after stillbirth and neonatal death, measured using qualitative interviews and focus group discussions conducted with participants during the intervention period until the end of the study 3. Factors influencing future scale-up and sustainability of the intervention, measured using intervention and site logs, minutes of bereavement champion meetings, peer support logs, plus complementary qualitative data from interviews and focus group discussions during the course of the trial. |
| Overall study start date | 01/06/2023 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | 840 |
| Participant inclusion criteria | 1. Women, birthed or received in-patient postnatal care in the included facility where the outcome was stillbirth or neonatal death: 1.1. Stillbirth (antenatal or intrapartum fetal death ≥28 weeks’ gestation or national definition) 1.2. Neonatal death (live birth at any gestation, baby(ies) died up to 28 days following birth in the facility 2. Over 16 years* at the time of recruitment 3. Able to speak Luganda, English or Kiswahili *Whilst 18 years is the age of majority, women over 16 years old who are pregnant, married, have a child or cater for their own livelihood are considered emancipated minors for the purposes of research |
| Participant exclusion criteria | Women who had a multiple birth, where one baby was liveborn and is still living |
| Recruitment start date | 26/02/2024 |
| Recruitment end date | 28/02/2025 |
Locations
Countries of recruitment
- Kenya
- Uganda
Study participating centres
Makerere University College of Health Sciences
Kampala
PO Box 7072
Uganda
University of Nairobi
Kenyatta National Hospital
Nairobi
PO Box 19676-00202
Kenya
Sponsor information
University/education
Pembroke Place
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)1517053100 |
|---|---|
| lstmgov@lstmed.ac.uk | |
| Website | http://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Active dissemination will include the usual 'business-to-business' model (funder reports, plain language summaries, conference presentations and academic journal papers) balanced with publicly accessible sources (newspapers, broadcast, and social media) and policy focus (briefs, bulletins). All researchers and CEI members will be invited to have an active role in dissemination. The results from this work will be published as soon as possible. All papers will be submitted to high-level open-access health journals. The Uniform Requirements for Manuscripts Submitted to Biomedical Journals (http://www.icmje.org/) will be used to assist with clear reporting. Individual researchers must undertake not to submit any part of their individual data for publication without the prior consent of the UMG. Local dissemination meetings will be held in Nairobi and Kampala for policymakers, healthcare providers and community members. Regional and International dissemination will be carried out through the LAMRN Network and International Stillbirth Alliance (ISA), amongst others. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Tracey Mills (tracey.mills@lstmed.ac.uk). The type of data that will be shared: Data will be provided in any open format (i.e. pdf, csv, r, stata etc.) using secure transfer methods i.e SSH portal secure end-to-end transfer or file encryption (AES 256-bit encryption), shared keys to be transferred separately to datasets. Dates of availability: Data will be published on a compliant data-sharing site such as Clinical Study Data Request (CSDR) once analyses have been completed for publication. Whether consent from participants was required and obtained: Participants give informed written consent that any anonymised data collected may be shared with researchers at other institutions. Comments on data anonymization: A statistician will confirm any exclusions required (i.e. excluded data, anonymization). |
Editorial Notes
09/10/2024: The following changes were made:
1. The overall study start date was changed from 01/01/2023 to 01/06/2023.
2. The overall study end date was changed from 31/12/2025 to 30/06/2025.
3. The recruitment start date was changed from 04/12/2023 to 26/02/2024.
4. The recruitment end date was changed from 24/10/2024 to 28/02/2025.
07/12/2023: Study's existence confirmed by the Kenyatta National Hospital - University of Nairobi ERC and Makerere University.
