Title: Better maternity care pathways in pregnancies after stillbirth or neonatal death: A feasibility study
Funder: Department of Health and Social Care

Abstract: Background: Despite improvements in maternity care in the UK, around 1 in 220 pregnancies ends in stillbirth. The majority of women embark on another pregnancy, often soon after the baby s death. During subsequent pregnancies parents consistently report high stress and anxiety, often persisting beyond the birth of a healthy child. Psychological distress during pregnancy is a risk factor for poor outcomes, notably pre-term birth and small for gestational-age. In the longer term, persistence of stress and anxiety predicts disrupted early attachment with the subsequent baby, increasing the risk of parenting and social difficulties. Thus, appropriate emotional support is key in pregnancy after stillbirth or neonatal death and may decrease the risk of poor psychological, pregnancy and social outcomes. Our recent exploratory studies of womens and health professionals experiences of UK maternity care identified substantial variability in existing provision across units/clinicians. Many parents perceived suboptimal communication, lack of psychological support, preparation for birth and the transition to parenthood. Due to increased risk of recurrence, obstetric-led care and birth in a specialist maternity unit are recommended for most women with a history of perinatal loss. Within the current high-risk model, parents inevitably encounter many different professionals during their maternity care; this fragmentation impairs development of supportive relationships. A package of care improving continuity of midwifery support during subsequent pregnancy and beyond, and providing access to additional emotional support and parent education could improve psychological, physical and pregnancy outcomes. However no study has assessed whether it would be feasible to conduct a definitive trial to determine whether a new package of care would improve outcomes for parents and would be cost-effective for the NHS. Aim: To explore the feasibility of a trial of a multicomponent intervention focused on a midwife care co-ordinator to improve parents experiences and psychological wellbeing in pregnancy after stillbirth. Design: A prospective, pre and post observational cohort study over 36 months. Setting: Two large maternity units in North-West England: Burnley General Hospital (East Lancashire Healthcare Trust) and North Manchester General Hospital (Pennine Acute Trust). Sample: Forty pregnant women (20 in each site) who have previously experienced a stillbirth or neonatal death, are &le;12 weeks pregnant and not eligible for a specialist maternity service (e.g: cardiac disease, diabetes) will be recruited to the intervention. A separate group of 20 women (10 in each site) meeting the same criteria, having the current pattern of care at the same units, in the six months immediately preceding the introduction of the intervention will be recruited as controls to explore experiences of care and pilot data collection for a subsequent trial. Women recruited in the intervention phase will be allocated a named midwife who will coordinate their care in partnership with their named obstetrician; conduct antenatal visits, facilitate birth planning and continued postnatal contact, liaise with other health professionals and facilitate additional emotional support through regular contacts between appointments and provision of support/education sessions. Partners of women participating (up to 12) and health professionals involved in care (up to 15) will be recruited for interviews to explore their experiences of the research and the intervention. Outcomes: The main outcomes will be recruitment and retention of women and their partners, and acceptability of the intervention. The experiences of health professionals in delivering the intervention and methods of assessment of fidelity in practice compared with planned intervention will also be explored. This study will inform the design of a UK-wide cluster randomised trial to test the impact and cost-effectiveness of the intervention on range of clinical, psychological and health economic outcomes, potential funding will be sought under the NIHR Health Services and Delivery Research Programme (HS&DR).

Lay abstract: In the UK, 13 babies die shortly before or soon after birth every day, causing long lasting grief for parents. Most women who have had a stillbirth or neonatal death conceive again, often soon after the loss. Subsequent pregnancies are associated with high stress and anxiety for parents, increasing complications such as the baby being born too early or too small. Difficult feelings and emotions often persist, even after the birth of a healthy baby and can disrupt early bonding, making family and social problems more likely later in life. Sensitive and appropriate support is vital for parents in pregnancy after the death of a baby. However, our recent research demonstrated that not all parents had good care all of the time; tactless and insensitive communication and lack of emotional support were common issues. This study will examine whether it is possible to conduct research testing a new package of care to improve support for parents who have previously experienced death of a baby. Women would have a named midwife care-coordinator, who would deliver antenatal care alongside their doctor, maintain a relationship with the family in pregnancy and during the early days after birth and provide access to extra support. This change will be introduced with a small group of women in two hospitals in North-West England and compared with similar women who received care immediately prior to the change. We will assess whether parents are willing to take part and stay in the research study, whether the change works as planned and the best ways of assessing the effect on well-being and maternity services. If this is study is successful we will seek funding for a larger study to assess whether this change would benefit women, represents good value for money and should be introduced to the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH