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Improving Perinatal Bereavement Support Trial (Kenya & Uganda)

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202402576062416
Enrollment
840
Registered
2024-02-02
Start date
2024-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and Behavioural Disorders Pregnancy and Childbirth

Interventions

ABC Workshop
Bereavement Champions and perinatal bereavement care group
Peer Support
Usual care
Perinatal Bereavement Support

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Women who had a multiple birth, where one baby was liveborn and is still living.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
- 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

Countries

Kenya, Uganda

Contacts

Public ContactTracey Mills

Senior Lecturer in Maternal and Newborn Health

tracey.mills@lstmed.ac.uk+441518321694

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026