Perinatal bereavement support Pregnancy and Childbirth
Conditions
Interventions
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 duri
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Women who had a multiple birth, where one baby was liveborn and is still living
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal grief intensity measured using a Kiswahili or Luganda version of the Perinatal Grief Intensity Scale (PGIS) at 8-12 weeks after birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Kenya, Uganda
Contacts
Public ContactTracey Mills
Outcome results
None listed