Pregnancy after stillbirth Pregnancy and Childbirth Pregnancy after stillbirth
Conditions
Interventions
Phase 1: (Pre-implementation - control phase)
Women recruited during the control phase will have existing care provided for women with subsequent pregnancies following stillbirth. The
refine content and delivery of the intervention and pilot data collection tools for the subsequent trial.
• A group comprising of women having the current standard of antenatal care at
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women 18 years or over, at the time of recruitment, booking at the study site for antenatal care (during Phases 1 and 2) with subsequent pregnancy following stillbirth (baby born dead at 28 weeks gestation or more, with a birth weight of 1000grams or more or a body length of 35cm or more (WHO, 2019)) OR 2. Health workers (midwives, nurses, obstetricians, and support staff), and other hospital staff, including managers and administrators directly involved in the study intervention or who provide care of services to pregnant women at the study site
Exclusion criteria
Exclusion criteria: Unable to give consent (pregnant women group)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The key feasibility outcomes will be recruitment and retention of women in the study. Other outcomes will include: 2. Acceptability and uptake of the intervention and experiences of study processes which will be explored through questionnaires and interviews with women and healthcare staff (midwives, nurses, obstetricians, and support staff), involved with the delivery of antenatal care 3. Psychological measures: 3.1. The extent and content of worries in pregnancy (women) measured using the Cambridge Worry Scale at baseline (at first visit to antenatal clinic at the study site) and outcome (at the end of their pregnancy) (both Phase 1 and 2). 3.2. Knowledge, attitudes and perceptions of preparation for childbirth (women) Birth Preparedness and Complications Readiness Tool at baseline (at first visit to antenatal clinic at the study site) and outcome (at the end of their pregnancy) (both Phase 1 and 2). 3.3. Questionnaire to assess awareness of the research, experiences of either routine antenatal care or the intervention and to capture any wider impacts on practice (women & staff) at baseline (at first visit to antenatal clinic at the study site) and outcome (at the end of their pregnancy) (both Phase 1 and 2) for women and baseline (at time of recruitment to study) (phase 1 & 2) and outcome (at end of recruitment of women (for phase 1) and when last woman delivered (for phase 2)) for health care staff. 4. Clinical measures: 4.1. 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]) medical (history, body mass index, smoking status, medication use), obstetric history (pre | — |
Countries
Zimbabwe
Outcome results
None listed