Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes [DIAAS]
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18,000
- 试验地点
- 1
- 主要终点
- Severe neonatal morbidity (composite)
研究概览
简要总结
This study is the first in the United Kingdom (UK) to look at how women and families from different backgrounds use ambulance services during the 'perinatal period' - through pregnancy, birth, and shortly after having a baby. The researchers want to understand whether all women have the same access to urgent and emergency maternity care, and whether there are differences in health outcomes for mothers and babies who use ambulance services.
The study has two parts (called Work-Packages):
Work Package One will look at data from women who were taken by ambulance to a Manchester University National Health Service (NHS) Foundation Trust (MFT) maternity unit during the perinatal period, compared with those who had a baby at MFT but were not taken there by ambulance. It will look at the differences between the two groups and their health outcomes.
Work Package Two will look closely at the text written by paramedics within ambulance records for some women from Work Package One, especially those at increased risk of a poor outcome. The researchers will study what happened during their care journey and look for anything that happens repeatedly within the text to better understand their experiences.
By combining the results from both work packages, the study aims to give a detailed picture of how different women access emergency maternity care and outcomes for themselves and their babies. This will help identify ways to improve services, especially for women who may face barriers to getting the care they need, helping to make sure that maternity care is safe, fair, and more effective for everyone.
详细描述
Background:
This study will be the first United Kingdom (UK)-based study to investigate access to ambulance services for women and families from diverse backgrounds during pregnancy, birth and early postpartum period. The study will explore relevant maternal and infant outcomes for families who seek help from the ambulance service to explore health disparities in accessing urgent and emergency care. Findings from this study will inform local and national policy aimed at reducing maternal and perinatal mortality and morbidity. This will contribute to the identification of access challenges experienced by seldom-heard women in a crucially important, but under investigated area of unscheduled urgent and emergency maternity care.
Methods:
A mixed methods approach including two work packages (WP). WP1 includes a retrospective comparative cohort study (WP1) to describe the characteristics of and outcomes for pregnant women and their neonates who are transferred via ambulance to Manchester University National Health Service (NHS) Foundation Trust (MFT) and those that are not. Descriptive statistics with comparative analyses will be presented. WP2 includes a qualitative framework analysis of a purposive sub-sample of routinely collected free-text digital records documented by paramedics for women who arrived at the unit via ambulance. Purposive sampling will be undertaken for women who are identified at an increased risk of poor maternal and/or neonatal outcomes following WP1 analyses. The patient journey will be mapped, and patient profiles constructed. An explanatory mixed methods approach will be undertaken for triangulation of data for insight.
Discussion:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •North West Ambulance Service (NWAS) Cohort:
- •Had at least one pregnancy start and/or gave birth between 1st August 2022 to 31st August 2024
- •Accessed NWAS service in the perinatal period between 1st August 2022 to 31st August 2024, and were subsequently transferred to an Manchester University NHS Foundation Trust (MFT) maternity unit by ambulance (either to Saint Mary's Oxford Road, Saint Mary's Wythenshawe or Saint Mary's North Manchester sites)
- •Can be linked to the HIVE electronic patient record (EPR) database
- •Has an electronic delivery record on the MFT HIVE database
- •Has not opted out of NHS national data opt-out usage.
- •Comparison Manchester University NHS Foundation Trust (MFT) Cohort:
- •Had at least one pregnancy start and/or gave birth between 1st August 2022 to 31st August 2024
- •Not transferred by ambulance to an MFT maternity unit after contacting NWAS during the perinatal period
- •Attended MFT maternity unit for birth (either Saint Marys Oxford Road, Saint Marys Wythenshawe or Saint Mary's North Manchester Sites) and therefore has an electronic birth record on the MFT HIVE EPR database
- •Has not opted out of NHS national data opt-out usage.
- •Work Package 1
排除标准
- •Opted out of NHS national data usage
- •No pregnancy start or end date recorded/imputed
- •No birth record on the MFT HIVE EPR database
- •Was conveyed by ambulance to a non-MFT maternity unit/site.
- •Work Package 2
- •Inclusion Criteria:
- •Had at least one pregnancy and/or gave birth between August 2022 to August 2024
- •Accessed NWAS service in the perinatal period between August 2022 to August 2024, and subsequently transferred to an MFT maternity unit by ambulance (either St Marys Oxford Road, St Marys Wythenshawe or North Manchester Sites)
- •Has not opted out of NHS national data opt-out usage.
- •Work Package 2
- •Exclusion criteria:
- •- Opted out of NHS national data usage.
结局指标
主要结局
Severe neonatal morbidity (composite)
时间窗: Up to 6 weeks postpartum.
Including stillbirth, neonatal death, admission to neonatal intensive care unit, APGAR score \<7 at 5 minutes, fetal growth restriction, low arterial cord pH, early preterm birth (\<34 weeks), birth injuries and Hypoxic Ischemic Encephalopathy (HIE) diagnosis.
Severe maternal morbidity (composite)
时间窗: Up to 6 weeks pospartum
Including maternal death, admission to high dependency or intensive care areas, postnatal hospital readmission, major postpartum haemorrhage (PPH), obstetric anal sphincter injury (OASI), unplanned hysterectomy, placental abruption, eclampsia and Hemolysis Elevated Liver Enzymes and Low Platelets (HELLP) syndrome.
次要结局
- Mode of birth(Up to 6 weeks postpartum.)
- Postpartum Haemorrhage(Up to 6 weeks postpartum)
- Maternal death(Up to 6 weeks postpartum)
- Unplanned hysterectomy(Up to 6 weeks postpartum)
- Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP syndrome)(Up to 6 weeks postpartum)
- Stillbirth(Up to 6 weeks postpartum)
- Neonatal Death(Up to 28 days after birth.)
- Fetal growth restriction(Up to 6 weeks postpartum)
- Low arterial cord pH at birth(Up to 6 weeks postpartum)
- Obstetric cholestasis(Up to 6 weeks postpartum)
- Venous thromboembolism(Up to 6 weeks postpartum)
- Admitted to Intensive Care Unit or High Dependency Unit(Up to 6 weeks postpartum)
- Episiotomy(Up to 6 weeks postpartum)
- Length of stay in hospital after birth (maternal and neonatal)(Up to 6 weeks postpartum)
- Number of antenatal visits and ultrasound scans(Up to 6 weeks postpartum)
- Readmission to hospital in postnatal period(Up to 6 weeks postpartum)
- Major Postpartum Haemorrhage(Up to 6 weeks postpartum)
- Obstetric Anal Sphincter Injury (OASI)(Up to 6 weeks postpartum)
- Placental abruption(Up to 6 weeks postpartum.)
- Eclampsia(Up to 6 weeks postpartum)
- Pre-eclampsia(Up to 6 weeks postpartum)
- Antepartum haemorrhage(Up to 6 weeks postpartum.)
- Gestational hypertension(Up to 6 weeks postpartum)
- Small for Gestational Age (SGA)(Up to 6 weeks postpartum)
- Large for Gestational Age (LGA)(Up to 6 weeks postpartum)
- Low neonatal axillary temperature(Up to 6 weeks postpartum)
- Need for blood transfusion(Up to 6 weeks postpartum)
- Fetal loss <24 weeks' gestation(Up to 6 weeks postpartum)
- APGAR score <7 at 5 minutes(Up to 6 weeks postpartum)
- Preterm birth(Up to 6 weeks postpartum)
- Birth-related injury(Up to 6 weeks postpartum)
- Diagnosis of Hypoxic Ischemic Encephalopathy (HIE)(Up to 6 weeks postpartum)
- Gestational diabetes(Up to 6 weeks postpartum)
- Admitted with COVID-19, RSV, Whooping Cough or Influenza(Up to 6 weeks postpartum.)
- Admission to Neonatal Intensive Care Unit (NICU)(Up to 6 weeks postpartum)
- Cord prolapse(Up to 6 weeks postpartum)
- Birth before arrival at hospital (BBA)(Up to 6 weeks postpartum)
- Breastfeeding at discharge(Up to 6 weeks postpartum)
- Low birth weight (LBW)(Up to 6 weeks postpartum)
- High Birth Weight (HBW)(Up to 6 weeks postpartum)
研究者
Stephanie Heys
Chief Investigator and Consultant Midwife (North West Ambulance Service NHS Foundation Trust)
Manchester University NHS Foundation Trust