Tommy's National Rainbow Clinic Study: a protocol for a multi-site cohort study to evaluate a specialist antenatal service for women and families following a stillbirth or neonatal death.

INTRODUCTION

In the UK, each year, approximately 2250 babies are stillborn, and there are an additional 1150 neonatal deaths. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of grief. Most women who have experienced the loss of a baby will embark on another pregnancy, usually within a year. Parents need specialist support from doctors and midwives in a future pregnancy to reduce the risk of pregnancy complications and meet care and support needs. The Rainbow Clinic aims to meet these needs and was first established in 2013 at Saint Mary's Hospital, Manchester. Initial studies have shown that this model of care improves pregnancy outcomes, decreases anxiety levels and is associated with a strong social return on investment. The Tommy's National Rainbow Clinic Study aims to evaluate the care provided within this new model, to examine women's experiences of care and identify areas of improvement and measure the impact on pregnancy outcomes for mothers and babies.

METHODS AND ANALYSIS

This is a prospective cohort study, measuring a range of maternal and neonatal outcomes following care in Rainbow Clinic. The primary outcome measure is the frequency of stillbirth in the subsequent pregnancy. Measures of maternal well-being include maternal anxiety and psychological symptoms (assessed using Generalised Anxiety Disorder 2-item screening tool (GAD-2), the Cambridge Worry Scale and the Edinburgh Postnatal Depression Scale). Women's experiences of attending Rainbow Clinic will be recorded on a standardised patient experience tool. Data will be collected on resource use, including the number of appointments with health professionals and the number of ultrasound scans performed. Up to 2000 participants are expected to be enrolled in this study.

ETHICS AND PLANNED DISSEMINATION

This study was given a favourable ethical opinion by the South Central-Hampshire B Research Ethics Committee (Reference 20/SC/0180). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will inform the development and evaluation of models of specialist antenatal care for pregnancies after stillbirth and neonatal death.

TRIAL REGISTRATION NUMBER

The study is registered with the clinicaltrials.gov under the registration number NCT04393259.