Stillbirth or neonatal death in current pregnancy Pregnancy and Childbirth
Conditions
Interventions
A pre and post cohort design, over 14 months, will be conducted to allow implementation of the intervention in one site in each country and assessment of the feasibility of a full-scale effectiveness
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women: 1. Immediate postnatal period 2. Experienced stillbirth (baby born at or after 28 weeks gestation with no signs of life) or early neonatal death (live birth, died 0-6 days before discharge) in the included facilities, within the study recruitment periods 3. Over 18 years at time of recruitment Partners/family members/friends: 1. Identified by women consented to take part in the study during the intervention period only; they will be approached via the woman after she has agreed (a partner’s etc unwillingness to participate will not affect the woman’s continued participation) 2. Aged 18 years or over, at the time of recruitment Health workers: 1. Midwives/nurses, doctors, support staff and others directly involved in the delivery of the study intervention or who provide care or services to women after stillbirth in facilities. 2. Survey only: Health workers involved providing or managing maternity or neonatal services, but not previously directly involved in the research
Exclusion criteria
Exclusion criteria: 1. Women who are unable to give consent 2. Multiple births only where one baby survived the early neonatal period (women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment and retention of women in the study, measured using the study screening and recruitment log at identification of each eligible participant, approach, recruitment and study completion, withdrawal or loss to follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability and uptake of the intervention and experiences of study processes, explored via semi-structured face-to-face or telephone interviews with the following groups: 1.1. Women participating in the study in n up to 120; up to 60 per country) at 6 -8 weeks after the birth 1.2. Partners and family members of women participating in the intervention period (N; up to 60; up to 30 per country) at 6-8 weeks after the birth 1.3. Health workers and others (e.g. parent peer supporters) involved in the delivery of the intervention (up to 30; up to 15 per country) in October – December 2023 2. Characteristics and acceptability of the proposed psychological measures assessed using: 2.1. The Edinburgh Postnatal Depression Score (EPDS) at 6-8 weeks post birth 2.2. The Perinatal Grief Intensity scale (PGS) at 6-8 weeks post birth | — |
Countries
India, Pakistan
Contacts
Public ContactTracey Mills
Outcome results
None listed