NCT07049263

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Sep 2024Jun 2026

Study Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

June 20, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

Emergency maternity carePre-hospital maternity careHealth disparitiesHealth inequalitiesPerinatal periodMaternity care accessEthnicityDeprivationData linkageRetrospective cohort studyMixed methodsPre-hospital

Outcome Measures

Primary Outcomes (2)

  • Severe neonatal morbidity (composite)

    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.

    Up to 6 weeks postpartum.

  • Severe maternal morbidity (composite)

    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.

    Up to 6 weeks pospartum

Secondary Outcomes (40)

  • Mode of birth

    Up to 6 weeks postpartum.

  • Postpartum Haemorrhage

    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

  • +35 more secondary outcomes

Study Arms (2)

NWAS Cohort

A cohort of women who were transferred to Manchester University NHS Foundation Trust during the perinatal period by North West Ambulance Services, between August 2022 and August 2024.

MFT Cohort

A cohort of women who attended Manchester University NHS Foundation Trust for birth between August 2022 and August 2024, but were not transferred by North West Ambulance Services.

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Attended a Manchester University NHS Foundation Trust (MFT) maternity unit.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • \- Opted out of NHS national data usage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator and Consultant Midwife (North West Ambulance Service NHS Foundation Trust)

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 3, 2025

Study Start

September 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 2, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data will be anonymised by the Manchester NHS Foundation Trust (MFT) Clinical Data Science Unit (CDSU) following NHS Data Opt-Out being applied. No personalised patient data will be handled by the DIAAS research team.

Locations