Advancing care and support for women and families after stillbirth or neonatal death in Uganda and Kenya
| ISRCTN | ISRCTN68506895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68506895 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2019-7322-11551 |
| Sponsor | University of Manchester |
| Funder | National Institute for Health Research |
- Submission date
- 04/02/2020
- Registration date
- 25/02/2020
- Last edited
- 15/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Globally, 2.6 million babies a year die shortly before, during or soon after birth. More than half of these deaths occur in Sub-Saharan Africa, where the average rate is about eight times higher than in wealthy nations. It is well established that stillbirth is a distressing and traumatic experience for parents with long-lasting effects such as depression and other serious mental health issues, which are linked with higher rates of physical health problems, relationship and family breakdown. Reducing the impact of stillbirth has been identified as an important international health priority for sustainable development. Preventing as many stillbirths as possible through improvements in maternity and general healthcare is very important, but it is also imperative that good care is provided for women and families whose baby dies. Research across many different countries has shown that parents are not always treated with respect and compassion or offered the support they need after stillbirth. This is important; all people wherever they live should have a right to expect basic humane care after the death of a baby. Poor experiences with healthcare can impair adjustment and recovery, impair the parent’s ability to care for others (including remaining children), and also might deter them from accessing health services when the need arises in the future. A study in eastern Uganda showed that the health system and community support structures were inadequate in providing support to affected families. Recent research in Kenya and Uganda also identified lack of support for parents in facilities and after discharge home in Kenya and Uganda. Common practices surrounding stillbirth in some countries caused distress to parents, including not being encouraged to see and hold stillborn babies and lack of public mourning. Lack of education and support from health systems made it more difficult for professionals to provide good support. This study will examine the acceptability and feasibility testing of a new package of care to improve support for parents after stillbirth or neonatal death in Kenya and Uganda and the feasibility of a full-scale trial to evaluate the effectiveness of the package.
Who can participate?
1. Women aged 18 or over, in the immediate postnatal period, whose baby was stillborn or died soon after birth
2. Their partners and family members, aged 18 or over
3. Health workers (midwives, nurses, doctors and support staff) and peer supporters directly involved in the delivery of the study intervention or who provide care or services to women after stillbirth in facilities
What does the study involve?
Health workers and support staff with an interest in bereavement care in two facilities will come together forming a Perinatal Bereavement Care group that will act collectively to develop strategies to improve care for women and families. Members will act as Bereavement Champions to drive improvement in individual clinical areas. A network of community peer supporters linked to the group will be developed to offer telephone support to women in the early postnatal period. This change will be introduced with a small group of women in two hospitals in Kenya and Uganda and compared with similar women who received care immediately prior to the change. The researchers will assess whether parents are willing to take part and stay in the research study, whether the change works as planned, and the best ways of assessing the effect on well-being and maternity services.
What are the possible benefits and risks of participating?
This research will allow the researchers to understand how this new package to improve bereavement care works in practice, whether changes are needed and if it is possible to do a larger research study to prove that it helps women and families and is cost effective. It is hoped that women in phase 2 of the study will find the extra support useful, but it cannot be guaranteed that it will be. The main risk is potential for emotional distress. The period immediately following the death of a baby is very traumatic for parents, families and health workers and there is potential for emotional distress during participation in research during this time. For this study, women and families might exhibit emotional distress during recruitment, contacts with peer supporters, during the completion of questionnaires or interviews with the research assistant. This could occur when discussing experiences related to the recent death of the baby and their emotions and feelings.
Where is the study run from?
1. College of Health Sciences, Makerere University (Uganda)
2. School of Nursing Sciences, University of Nairobi (Kenya)
When is the study starting and how long is it expected to run for?
August 2019 to July 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Dr Tracey Mills
tracey.mills@lstmed.ac.uk
2. Prof. Tina Lavender
Tina.lavender@lstmed.ac.uk
(updated 02/09/2021, previously: tina.lavender@manchester.ac.uk)
Contact information
Public
Jean Mc Farlane Buiding
The University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)1613067709 |
|---|---|
| tracey.mills@lstmed.ac.uk |
Scientific
Department of International Public Health, The Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
 ORCID ID |
0000-0003-1473-4956 |
|---|---|
| Phone | +44 (0)7874852886 |
| Tina.lavender@lstmed.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Pre and post mixed methods feasibility study conducted in two sites over 12 months using a cohort design |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Advancing care and support for women and families after stillbirth or neonatal death in Uganda and Kenya: a feasibility study |
| Study objectives | To assess the feasibility of a full-scale evaluation to assess the effectiveness of a co-produced multicomponent intervention to improve immediate care in facilities and postnatal support after stillbirth or early neonatal death for women and families in Kenya and Uganda. |
| Ethics approval(s) | 1. Approved 05/08/2019, University of Manchester, Manchester UK, UREC committee 4 (University of Manchester Research Governance, Ethics and Integrity, 2nd Floor Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK; Tel: +44 (0)161 275 2206/2674; Email: research.ethics@manchester.ac.uk), ref: 2019-7322-11551 2. Approved 29/10/2019, Makerere University College of Health Sciences REC (School of Health Sciences Research and Ethics Committee Makerere University, PO Box 7072, Kampala, Uganda; Tel: +256 (0)200903786; Email: healthsciences.irb@gmail.com), ref: 2019-059 3. Approved 27/11/19, University of Nairobi/Kenyatta National Hospital Ethics and Research Committee (PO Box 19676 Code 00202, Nairobi, Kenya; Tel: +254 (0)202766300; Email: uonknh_erc@uonbi.ac.ke), ref: P828/09/2019 |
| Health condition(s) or problem(s) studied | Care after stillbirth or neonatal death |
| Intervention | A mixed-methods ‘before and after’ study, conducted over 12 months, will assess whether a full-scale trial to test the effectiveness of an intervention to improve care and support after stillbirth or neonatal death in sub-Saharan Africa is feasible. Intervention: Developed during previous and going co-production activities with the NIHR Stillbirth Research Group UK and Africa research teams, stakeholder and community engagement groups in Kenya and Uganda, will include two key components: 1. A Perinatal Bereavement Care Group to be set up in each facility and will meet 4-6 weekly during the intervention period to develop a vision for good bereavement care, strategies and activities to improve care in the facility including the development of evidence-based care pathways. The group will include: 1.1. Bereavement care champions, identified from existing health workers, 2 from each area (labour, postnatal ward, antenatal clinic, neonatal unit), who currently provide care to families after stillbirth or neonatal death. 1.2. Service managers, community engagement representatives and research team facilitators Group members will be offered training to extend knowledge of parent’s needs after stillbirth and behaviour change techniques to support better practice. 2. A community peer support network, supported by Perinatal Bereavement Care Group 2.1. Four to six volunteer peer supporters per facility will be identified from existing networks; criteria will include women with previous experience of stillbirth or neonatal death, at least 12 months ago, does not have severe mental health issues. Will receive training from the research team. 2.2. Will offer telephone peer support to postnatal women during the intervention period, initiated from 2 weeks after hospital discharge 2.3. Peer supporters will link with Bereavement Care Champions/Group in facilities for support, debriefing, advice and referrals Study Setting: Two maternity units; Kenyatta National Hospital, Nairobi, Kenya and Naguru Hospital, Kampala, Uganda. The study will be conducted in two phases: Phase 1 (‘Before’ intervention: approx. August 2019-January 2020) women and families will receive current postnatal care offered by the facility. 1. Training packages will be developed for the Perinatal Bereavement Care Group and Bereavement Champions. 2. To assess the feasibility of data collection, the researchers will approach as many postnatal women as possible experiencing a stillbirth or neonatal death in the included facilities from September to November 2019, aiming to recruit 20 to 30 women per country (maximum 60 total sample for this phase) 3. Participants will be asked to provide demographic, medical and birth data at recruitment and at 8 weeks after the birth, health and health care utilisation data will be obtained and a short psychological questionnaire completed. 4. Follow up for phase 1 participants will be completed by January 2020. 5. Perinatal care group members, bereavement champions and peer supporters will be identified and trained during December 2019 and January 2020 to minimise contamination between the study phases 6. To allow overall comparison with participants recruited to the study, the researchers will seek permission to extract anonymised data for all stillbirths and neonatal deaths occurring from August 2019-July 2020 from the facility birth registers. Phase 2 (‘After’ intervention phase: approx. February 2020-July 2020); women and families will continue to receive current postnatal care and the intervention will be introduced in both facilities. To assess the feasibility of data collection, acceptability of the intervention and recruitment and retention of participants the researchers will: 1. Approach as many postnatal women experiencing a stillbirth or neonatal death in the included facilities as possible from March to May 2020, aiming to recruit a further 20-30 women, (maximum sample 60 for this phase). 2. Participants will be offered the peer support component at study recruitment (not sooner than 2 weeks after discharge from facilities). 3. Demographic, medical and birth data will be collected at recruitment; Participants will then be followed up 8 weeks after birth to complete health and psychological questionnaires and be invited to take part in a one to one interview exploring experiences of postnatal support. 4. Data for recruitment and numbers of participants who stay in the study until completion will be collected 5. Invite partners and family members of women recruited in phase 2 (up to 10 per country; total sample of 20) to an interview to explore their experiences around 8 weeks after the birth. 6. Provide the Perinatal Bereavement Care Group, bereavement champions and peer supporters with intervention logs to record delivery of the intervention and invite them to an interview (up to 20 per country) at the end of the study. 7. Assess wider impacts on services and care in facilities by inviting all health workers providing care for women experiencing a stillbirth or neonatal death, but not directly involved in delivering the intervention, to complete a short questionnaire at the end of the study. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Recruitment and retention of women in the study: |
| Key secondary outcome measure(s) |
1. Demographic and clinical data: investigator-designed case report forms will be used to collect data for women participants via patient health records (including hospital, patient-held and electronic records) and self-report (where no secondary source available): demographic (age, ethnicity, socioeconomic status [highest level of education, occupation]) and obstetric history, index pregnancy data including the onset of labour, mode of birth, maternal and infant outcomes, cause of death (if known) length of hospital stay, and postnatal complications/all healthcare utilisation and access to external support up to 8 weeks postnatal. Data will be collected at recruitment and 6-8 weeks post-birth (study completion). Basic demographic data (age, ethnicity, socioeconomic status, etc) will also be collected via self-report for participating partners/family members, health workers and support staff at recruitment. Anonymised routinely collected clinical data for all births resulting in stillbirth or early neonatal death, in the included facilities during the study period will be extracted from the hospital birth registers. This will include maternal age, county of residence, occupation classification, medical and obstetric history (previous pregnancies, mode of birth, outcomes), index pregnancy data including the gestation, onset of labour, mode of birth, maternal and infant outcomes, cause of death (if known) and length of hospital stay. This will permit assessment of the feasibility of comparison and assessment of the potential for selection bias in sample taking part in the research. |
| Completion date | 31/07/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 320 |
| Total final enrolment | 176 |
| Key inclusion criteria | Postnatal women: 1. In the immediate postnatal period 2. Baby was stillborn (baby born at or after 28 weeks gestation with no signs of life) or died soon after birth in the facility (early neonatal death 0-6 days]) during one of the two identified recruitment periods in phase 1 and 2 3. Aged 18 years or over, at the time of recruitment Partners and family members: 1. Of women consented to take part in the study; they will approached via the woman after she has agreed (a partner’s unwillingness to participate will not affect the woman’s continued participation) 2. Aged 18 years or over, at the time of recruitment Health workers (midwives, nurses, doctors and support staff) and peer supporters: 1. Directly involved in the delivery of the study intervention or who provide care or services to women after stillbirth in facilities |
| Key exclusion criteria | 1. Unable to give consent 2. Multiple births only where one baby survived the early neonatal period |
| Date of first enrolment | 01/12/2019 |
| Date of final enrolment | 30/09/2020 |
Locations
Countries of recruitment
- Kenya
- Uganda
Study participating centres
PO Box 20145
Kampala
-
Uganda
PO Box 20723
Nairobi
00202
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Tina Lavender (tina.lavender@manchester.ac.uk). Type of data: anonymised quantitative and qualitative. Available following the full publication of findings and for 5 years following completion and publication of results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.1 | 24/07/2019 | 05/10/2022 | No | No |
Additional files
- 37825 protocol_v1.1 24July19.pdf
- Protocol file
Editorial Notes
15/08/2023: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 01/06/2020 to 30/09/2020.
05/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
08/07/2022: The intention to publish date has been changed from 01/07/2022 to 30/11/2022.
06/01/2022: The intention to publish date has been changed from 01/07/2021 to 01/07/2022.
02/09/2021: Contact details updated.
02/03/2021: The recruitment resumed.
18/12/2020: Contact details updated.
23/07/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/07/2020 to 31/07/2021.
2. Due to current public health guidance, recruitment for this study has been paused.
10/02/2020: Trial's existence confirmed by University of Manchester Research Ethics Committee 4.
