Maternity care during pregnancy after stillbirth or neonatal death Pregnancy and Childbirth Maternity care during pregnancy after stillbirth or neonatal death
Conditions
Interventions
This prospective, observational mixed-methods study determines the feasibility of conducting a large trial of a new care package to improve the emotional and psychological support for parents in pregn
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women and Partners: 1.1. Pregnant women over 16 years old and =20 weeks’ gestation and have experienced a stillbirth or a neonatal death of any previous baby 1.2. Partners, approached through the woman after she has agreed (a partner’s unwillingness to participate will not affect the woman’s continued participation) 1.3. Booked and planning have antenatal care at East Lancashire Hospitals NHS Trust or Pennine Acute Trust 1.4. For feasibility, sufficient command of English to participate in interviews and complete questionnaires will be required. Translation of materials will be explored with the aim of including parents lacking fluency in English in the definitive trial. 2. Health workers: 2.1. Midwives, obstetricians, service managers directly/indirectly involved in providing care to women participating in the study
Exclusion criteria
Exclusion criteria: 1. Pregnant women/partners under 16 years 2. Women/partners who are already receiving care through a specialist antenatal service (eg diabetes, haematology clinics) as they would be receiving specialist midwifery/obstetric care relevant to their complex history. 3. Participants who are unable or unwilling to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates of women and partners recorded as the number of eligible participants who consent to take part, measured using the participant log, at the end of the study. 2. Retention of women and their partners recorded as the number of participants who remain in the study until completion, measured using the participant log, at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Experiences of study participation and the intervention of parents and healthcare staff to determine the acceptability of trial processes and of the intervention. Explored through qualitative interviews, 4-6 weeks after birth (women and partners) and at the end of data collection (health professionals) 2. The characteristics of proposed psychological, cost-effectiveness, utility and clinical outcome measures will be examined in preparation for a definitive trial. These will be assessed by completion of validated self-report questionnaires (Generalised Anxiety Disorder 7 item scale (GAD-7) completed by women and partners at recruitment, 30-37 weeks and 4-6 weeks after the birth. Cambridge Worry Scale completed by women only at recruitment and 30-37 weeks gestation. Edinburgh Postnatal Depression Score completed by women only at recruitment, 30-37 weeks and 4-6 weeks after birth. Maternal-Infant Bonding scale completed by women only at 4-6 weeks after the birth. Maternal Self Efficacy Scale, (MSES) an 8-item scale to assess women’s self-belief in their abilities to meet the needs of their infant, will be completed by women at 4-6 weeks after birth.Investigator designed case report forms (clinical outcomes)completed at recruitment, 30-37 weeks gestation and 4-6 weeks postnatal. 3. Elements of process evaluation will assess fidelity and quality of implementation, clarify causal mechanisms and identify contextual factors impacting on outcomes. Fidelity will be assessed using the intervention logs completed by care co-ordinators during phase two, case report forms completed at 30-37 weeks gestation and 4-6 weeks after the birth and interviews with women and partners 4-6 weeks after birth and health professionals at the end of data collection | — |
Countries
England, United Kingdom
Outcome results
None listed