Trial no.:	PACTR202402576062416	Date of Approval:	02/02/2024
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Improving Perinatal Bereavement Support Trial (Kenya & Uganda)

Official 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 randomised controlled trial.

Brief summary describing the background and objectives of the trial

Globally, 2 million babies were stillborn and 2.4 million died within 28 days after birth in 2019 (1), with 98% of perinatal deaths occurring in low and middle income countries (LMICs). The death of a baby before or soon after birth is among the most traumatic life-events for parents and families. Around 60-70% of women experience depressive symptoms, with at least 30% suffering prolonged intense grief reactions. Reducing the impact of stillbirth and neonatal death has been identified as an important international research priority. We know that having good care and support from health workers following the perinatal death has a positive effect in helping parents cope, and adjust to the loss. The Improving Perinatal Bereavement Support Trial (Kenya and Uganda) 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 implementation of a co-produced multicomponent intervention, which includes an educational workshop for health workers, 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. Other secondary objectives include assessment of the impact of the intervention on maternal anxiety, risk of depression and development, diagnosis, and treatment of mental health conditions, and the mediating effect of perceived social support, plus cost effectiveness and process evaluation objectives. (1) World Bank. Mortality rates neonatal (per 1000 live births) 2021 [Available from: https://data.worldbank.org/indicator/SH.DYN.NMRT.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Mental and Behavioural Disorders,Pregnancy and Childbirth

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Advanced Bereavement Care educational workshop, Bereavement Champions network and community telephone peer support in substudy clusters

Anticipated trial start date

01/01/2024

Actual trial start date

Anticipated date of last follow up

31/12/2025

Actual Last follow-up date

Anticipated target sample size (number of participants)

840

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study	Randomised	Dynamic (adaptive) random allocation such as minimization	Central randomisation by phone/fax	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	ABC Workshop	The number of workshops during the cross over period will depend on the number of staff at the site. Aim to train minimum 70% of staff at site. Team to also deliver additional workshops (at least 1 or 2) during the intervention period to capture new staff members.	Health care providers will be trained during the 6 week cross over period from usual care to the intervention phase. Each cluster will have 8 trial periods (of 6 weeks) and the intervention will take place for 1 to 6 trial periods depending on the randomly allocated order.	Advancing bereavement care (ABC) is a one-day educational workshop designed for delivery to qualified and / or student health workers including midwives, nurses and doctors in the participating facilities. The workshop learning objectives focus on (i) developing awareness of parents’ and families’ experiences and needs after their baby dies and (ii) knowledge and understanding of evidence informed practice. Participants will receive a copy of the workshop guide in advance and complete a short pre-reading activity prior to attendance. The workshop comprises 5 interactive sessions, delivered as exposition and small and large group work, including a context specific bereavement care educational film (‘The Heartbeat’).	15
Experimental Group	Bereavement Champions and perinatal bereavement care group	The number of training workshops during the cross over period will depend on the number of staff at the site. Ongoing meetings will occur monthly throughout the intervention phase.	The intervention will begin in the 6-week cross over period from usual care to intervention. Each cluster will have 8 trial periods (of 6 weeks) and the intervention will take place for 1 to 6 trial periods depending on the randomly allocated order.	The BC group will be created during the 6 week crossover period and start regular meetings in the first period 1 of intervention in each participating cluster. Eight to twelve health workers in post across maternity (antenatal clinic/ward, labour ward and postnatal wards) and neonatal services (neonatal care unit) who are committed to improving bereavement support for women and families as champions will be sought as members. Bereavement Champions will be prepared for their role with a 2-day training workshop which will focus on listening and communication, behaviour change techniques and motivational conversation skills and the group will identify initial areas of focus and activities to improve care. They will meet monthly, in person, facilitated by the research team to share experiences and progress.	12
Experimental Group	Peer Support	The number and mode (e.g. voice call/sms) of contacts will be determined individually according to participant preference, within peer supporter availability.	Peer support will be offered, at recruitment not sooner than two weeks after birth of the baby and after discharge home and will be ongoing from period 1 of usual care until intervention period 8	Telephone Peer Support is offered in addition to intervention components (ABC workshops and BC network). Participants recruited to the main trial in two clusters (one in each Kenya and Uganda) will be 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 death of a baby (stillbirth or neonatal death > 1 year prior to involvement) who have attended a training workshop and completed a peer support agreement. Total of 280 participants randomised to peer support (140 per country)	280
Control Group	Usual care	Bereaved postnatal women participants in the 6 clusters will be recruited from period 1, which is usual care, before that cluster progresses to the intervention phase in the preselected (randomised) order between period 2 and period 7. Clusters will have between 2 and 6 periods of usual care. Each trial period is 6 weeks duration and there are a total of 8 periods.	Each woman is recruited at 2 weeks post birth and will be followed up until they are 8-12 weeks postnatal. They will remain in the trial for approximately 6-10 weeks.	Usual postnatal and community care	420	Dose Comparison
Experimental Group	Perinatal Bereavement Support	Each cluster will progress to the intervention phase in the preselected (randomised) order between period 2 and period 7. Clusters will have from 1 to 6 periods of the intervention. Each trial period is 6 weeks duration and there are a total of 8 periods.	Bereaved postnatal women will be recruited at 2 weeks post birth and followed up at 8-12 weeks, therefore will be exposed to the intervention for a minimum of 6 weeks.	Perinatal bereavement support is provided in cluster sites where staff have been trained in the ABC education workshops and have a Bereavement Champion network.	420

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Women, birthed or received in-patient postnatal care in the included facility: - Outcome of the index pregnancy was a stillbirth (e.g., WHO antenatal or intrapartum fetal death ≥ 28 weeks’ gestation or national definition) or neonatal death (live birth at any gestation, baby(ies) died up to 28 days following birth in the facility. - Over 16 years* at time of recruitment (whilst 18 years is 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(22), 16-18 year olds have high rates of adverse pregnancy outcomes including stillbirth and neonatal death and may benefit from the intervention and research. - Able to speak Luganda, English or Kiswahili.	Women who had a multiple birth, where one baby was liveborn and is still living.	Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s)	16 Year(s)	50 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

02/05/2023

Liverpool School of Tropical Medicine

Ethics Committee Address
Street address	City	Postal code	Country
Pembroke Place	Liverpool	L3 5QA	United Kingdom

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

28/07/2023

Kenyatta National Hospital University of Nairobi ERC

Ethics Committee Address
Street address	City	Postal code	Country
PO Box 20723	Nairobi	00202	Kenya

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

12/09/2023

Makerere University REC

Ethics Committee Address
Street address	City	Postal code	Country
PO Box 7072	Kampala	7072	Uganda

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	The primary outcome measure for effectiveness will be maternal grief intensity, measured using a Kiswahili or Luganda version of the Perinatal Grief Intensity Scale (PGIS), assessed 8-12 weeks after birth	8-12 weeks post birth
Secondary Outcome	- Maternal anxiety using Generalised anxiety disorder 7 item scale (GAD-7) to assess generalised anxiety including in pregnancy and the postnatal period - Maternal postpartum depression using The Edinburgh Postnatal Depression Score (EPDS) 10-item tool developed to assess depressive symptoms for postnatal use and validated for use to identify anxiety and depressive symptoms in pregnancy - Diagnosis and treatment of maternal mental health conditions (via self-report), examples anxiety, depression, PTSD and psychosis, 8-12 weeks after birth - Maternal perception of social support using Multidimensional Scale of Perceived Social Support (MPSS) a 12 item measure of perception of adequacy of social support from three sources family, friends and significant others	8-12 weeks after birth

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Moi Teaching and Referral Hospital	Nandi Road	Eldoret		Kenya
Kapsabet District Hospital	C39, Kapsabet	Nandi County		Kenya
Kitale County Referral Hospital	Unnamed Road Hospital Kiminini	Trans Nzoia		Kenya
Kapenguria County Referral Hospital	West Pokot Ke, Makutano - Kapenguria Road	Kapenguria		Kenya
Pumwani Maternity Hospital	General Waruingi Street	Nairobi		Kenya
Mbagathi District Hospital	Mbagathi Road	Nairobi		Kenya
Njiru Health Centre	Nairobi Kangundo Road opposite St Michael Catholic Church	Kasarani		Kenya
Kawempe National Referral Hospital	Plot 1035/3883, Kawempe Bombo Road	Kampala		Uganda
Masaka Regional Referral Hospital	PO Box 18	Masaka		Uganda
Kayunga regional referral hospital	PO Box 18069	Kayunga		Uganda
Mukono General Hospital	PO Box 25	Mukono		Uganda

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
National Institute of Health and Care Research	Alpha House - Enterprise Road	Southampton	SO16 7NS	United Kingdom

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Liverpool School of Tropical Medicine	Pembroke Place	Liverpool	L3 5QA	United Kingdom	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Makerere University	Department of Nursing, Makerere University College of Health Sciences	Kampala		Uganda
University of Nairobi	Kenyatta National Hospital	Nairobi		Kenya

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Public Enquiries	Tracey Mills	tracey.mills@lstmed.ac.uk	+441518321694	Pembroke Place
City	Postal code	Country	Position/Affiliation
Liverpool		United Kingdom	Senior Lecturer in Maternal and Newborn Health
Role	Name	Email	Phone	Street address
Scientific Enquiries	Tracey Mills	tracey.mills@lstmed.ac.uk	+441518321694	Pembroke Place
City	Postal code	Country	Position/Affiliation
Liverpool		United Kingdom	Senior Lecturer in Maternal and Newborn Health
Role	Name	Email	Phone	Street address
Principal Investigator	Sabina Wakasiaka	swakasiaka@gmail.com	+254202711250	University of Nairobi
City	Postal code	Country	Position/Affiliation
Nairobi		Kenya	Senior Lecturer and Kenya PI
Role	Name	Email	Phone	Street address
Principal Investigator	Elizabeth Ayebare	lizayeby@gmail.com	+256414530404	University of Makerere
City	Postal code	Country	Position/Affiliation
Kampala		Uganda	Lecturer and Uganda PI

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Once the analyses of the data have been completed for publication, the data will be published on a compliant data sharing site such as the Clinical Study Data Request (CSDR). It is anticipated that data collected in this study will be suitable for unqualified access to researchers to facilitate secondary analysis in the future.	Statistical Analysis Plan,Study Protocol	After publication (intention to publish date 31/12/2026)	The datasets generated during and/or analysed during this trial will be available upon request from the Sponsor, Liverpool School of Tropical Medicine. The Chief Investigator will make the decision to supply research data to a potential new user(s).
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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