Care after stillbirth or neonatal death Not Applicable
Conditions
Interventions
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
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
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Unable to give consent 2. Multiple births only where one baby survived the early neonatal period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment and retention of women in the study: 1.1. Women who fulfill the eligibility criteria, women who are invited to participate in the study, those recruited and any participants who leave the study before completion, recorded in a participant log 1.2. Reasons for non-recruitment (e.g. refusal to participate, language barrier) will also be recorded. Permission will be sought to collect data on reasons for non-participation from women, partners/family members and health workers who have provided contact details but decline to take part 1.3. Reasons for withdrawal and loss to follow-up documented during the course of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 2. Acceptability of study processes and the intervention (phase 2) captured by semi-structured face to face (or telephone) interviews with: 2.1. Women participating in the study during phase 2 (N up to 60; up to 30 per country) 6 -8 weeks after the birth 2.2. Partners and family members of women participating in phase 2 (N; up to 30; up to 15 per country) 6-8 weeks after the birth 2 | — |
Countries
Kenya, Uganda
Contacts
Public ContactTracey Mills
Outcome results
None listed