Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes

Active, not recruiting

• Conditions: Emergency Maternity Care; Ethnicity; Disparities in Access to Maternity Care; Ambulances; Health Inequalities in Maternity Care Access; Deprivation; Pre-hospital

• Registration Number: NCT07049263
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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.

Detailed Description

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:

The study aims to provide an in-depth understanding of access to emergency maternity care to allow investigation of opportunities for alternative clinical decision making and review of current service provision. This also helps to identify women with increased risk factors for accessing urgent and emergency care as a gateway to maternity services. This will help to address timely access to the most appropriate services, reducing risk factors for adverse maternity and neonatal outcomes and associated impact upon the emergency services. Findings will be used to inform local and national interventions for at risk populations who access ambulance services during pregnancy, birth, and early postpartum. Findings will also support system conversations around the reasons for seeking help from the ambulance service in the perinatal period and ways to improve access and care provisions for underserved communities.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2025-08-01
• Study Completion: 2026-03-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 18000

Inclusion Criteria

1. 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.

2. 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

Exclusion Criteria

• 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:

• Female
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe neonatal morbidity (composite)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Maternal death	Up to 6 weeks postpartum	Maternal.
Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP syndrome)	Up to 6 weeks postpartum	Maternal
Antepartum haemorrhage	Up to 6 weeks postpartum.	Maternal.
Gestational hypertension	Up to 6 weeks postpartum	Maternal.
Gestational diabetes	Up to 6 weeks postpartum	Maternal.
Admission to Neonatal Intensive Care Unit (NICU)	Up to 6 weeks postpartum	Neonatal
Cord prolapse	Up to 6 weeks postpartum	Maternal
Birth before arrival at hospital (BBA)	Up to 6 weeks postpartum	Neonatal.
Breastfeeding at discharge	Up to 6 weeks postpartum	Neonatal.
Low birth weight (LBW)	Up to 6 weeks postpartum	Neonatal. Grams.
High Birth Weight (HBW)	Up to 6 weeks postpartum	Neonatal. Grams.
Mode of birth	Up to 6 weeks postpartum.	Maternal. Spontaneous vaginal birth, breech birth, instrumental birth (forceps, kiwi or ventouse) or Caesarean section birth.
Postpartum Haemorrhage	Up to 6 weeks postpartum	Maternal. 500ml - 2000ml
Unplanned hysterectomy	Up to 6 weeks postpartum	Maternal.
Stillbirth	Up to 6 weeks postpartum	Neonatal
Neonatal Death	Up to 28 days after birth.	Neonatal
Fetal growth restriction	Up to 6 weeks postpartum	Neonatal.
Low arterial cord pH at birth	Up to 6 weeks postpartum	pH \<7.05. Neonatal.
Obstetric cholestasis	Up to 6 weeks postpartum	Maternal.
Venous thromboembolism	Up to 6 weeks postpartum	Maternal.
Admitted to Intensive Care Unit or High Dependency Unit	Up to 6 weeks postpartum	Maternal. During the perinatal period.
Episiotomy	Up to 6 weeks postpartum	Maternal.
Length of stay in hospital after birth (maternal and neonatal)	Up to 6 weeks postpartum	Maternal and neonatal. Days.
Number of antenatal visits and ultrasound scans	Up to 6 weeks postpartum	Maternal.
Readmission to hospital in postnatal period	Up to 6 weeks postpartum	Maternal.
Major Postpartum Haemorrhage	Up to 6 weeks postpartum	Maternal. \>2000mls
Obstetric Anal Sphincter Injury (OASI)	Up to 6 weeks postpartum	Maternal. Third or fourth degree perineal tear.
Placental abruption	Up to 6 weeks postpartum.	Maternal.
Eclampsia	Up to 6 weeks postpartum	Maternal.
Pre-eclampsia	Up to 6 weeks postpartum	Maternal.
Small for Gestational Age (SGA)	Up to 6 weeks postpartum	Neonatal.
Large for Gestational Age (LGA)	Up to 6 weeks postpartum	Neonatal.
Low neonatal axillary temperature	Up to 6 weeks postpartum	Neonatal. On admission. Celcius.
Need for blood transfusion	Up to 6 weeks postpartum	Maternal.
Fetal loss <24 weeks' gestation	Up to 6 weeks postpartum	Maternal.
APGAR score <7 at 5 minutes	Up to 6 weeks postpartum	Neonatal
Preterm birth	Up to 6 weeks postpartum	Neonatal. \<34 weeks gestation.
Birth-related injury	Up to 6 weeks postpartum	Neonatal. Including brachial plexus injury, clavicular fractures.
Diagnosis of Hypoxic Ischemic Encephalopathy (HIE)	Up to 6 weeks postpartum	Neonatal.
Admitted with COVID-19, RSV, Whooping Cough or Influenza	Up to 6 weeks postpartum.	Maternal.

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom