Barron Rebecca L, Tomlinson Emma, Bailey Emilie, Heazell Alexander Ep
Manchester University Hospitals NHS Foundation Trust, Saint Mary's Hospital, Manchester, UK
Manchester University Hospitals NHS Foundation Trust, Saint Mary's Hospital, Manchester, UK.
BMJ Open. 2025 Aug 5;15(8):e103294. doi: 10.1136/bmjopen-2025-103294.
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.
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.
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.
The study is registered with the clinicaltrials.gov under the registration number NCT04393259.
在英国，每年约有2250例死产婴儿，另有1150例新生儿死亡。婴儿在出生前或出生后不久死亡，对女性及其家庭来说是极其痛苦的经历，之后往往会经历一段悲伤期。大多数经历过婴儿夭折的女性通常会在一年内再次怀孕。未来怀孕时，父母需要医生和助产士的专业支持，以降低怀孕并发症的风险，并满足护理和支持需求。彩虹诊所旨在满足这些需求，于2013年在曼彻斯特圣玛丽医院首次设立。初步研究表明，这种护理模式可改善妊娠结局，降低焦虑水平，并具有较高的社会投资回报率。汤米全国彩虹诊所研究旨在评估这种新模式下提供的护理，调查女性的护理体验，确定改进领域，并衡量对母婴妊娠结局的影响。
这是一项前瞻性队列研究，测量彩虹诊所护理后一系列孕产妇和新生儿结局。主要结局指标是后续妊娠中的死产频率。孕产妇幸福感的指标包括孕产妇焦虑和心理症状（使用广泛性焦虑症2项筛查工具（GAD - 2）、剑桥焦虑量表和爱丁堡产后抑郁量表进行评估）。女性在彩虹诊所就诊的体验将通过标准化的患者体验工具进行记录。将收集资源使用数据，包括与医疗专业人员的预约次数和进行超声扫描的次数。预计该研究将招募多达2000名参与者。
本研究获得了南中汉普郡B研究伦理委员会的有利伦理意见（参考编号20/SC/0180）。研究结果将在国际会议上展示，并发表在同行评审的开放获取期刊上。本研究的信息将为死产和新生儿死亡后妊娠的专科产前护理模式的开发和评估提供参考。
该研究已在clinicaltrials.gov上注册，注册号为NCT04393259。
