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NCT Number: NCT07049263

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Work Package 1

Inclusion criteria

  • 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

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.

Treatment and study plan

Primary outcomes

  1. Severe neonatal morbidity (composite)

    Time frame: 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.

  2. Severe maternal morbidity (composite)

    Time frame: 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 outcomes

  1. Mode of birth

    Time frame: Up to 6 weeks postpartum.

    Maternal. Spontaneous vaginal birth, breech birth, instrumental birth (forceps, kiwi or ventouse) or Caesarean section birth.

  2. Postpartum Haemorrhage

    Time frame: Up to 6 weeks postpartum

    Maternal. 500ml - 2000ml

  3. Episiotomy

    Time frame: Up to 6 weeks postpartum

    Maternal.

  4. Length of stay in hospital after birth (maternal and neonatal)

    Time frame: Up to 6 weeks postpartum

    Maternal and neonatal. Days.

  5. Number of antenatal visits and ultrasound scans

    Time frame: Up to 6 weeks postpartum

    Maternal.

  6. Need for blood transfusion

    Time frame: Up to 6 weeks postpartum

    Maternal.

  7. Fetal loss <24 weeks' gestation

    Time frame: Up to 6 weeks postpartum

    Maternal.

  8. Maternal death

    Time frame: Up to 6 weeks postpartum

    Maternal.

  9. Admitted to Intensive Care Unit or High Dependency Unit

    Time frame: Up to 6 weeks postpartum

    Maternal. During the perinatal period.

  10. Unplanned hysterectomy

    Time frame: Up to 6 weeks postpartum

    Maternal.

  11. Readmission to hospital in postnatal period

    Time frame: Up to 6 weeks postpartum

    Maternal.

  12. Major Postpartum Haemorrhage

    Time frame: Up to 6 weeks postpartum

    Maternal. >2000mls

  13. Obstetric Anal Sphincter Injury (OASI)

    Time frame: Up to 6 weeks postpartum

    Maternal. Third or fourth degree perineal tear.

  14. Placental abruption

    Time frame: Up to 6 weeks postpartum.

    Maternal.

  15. Eclampsia

    Time frame: Up to 6 weeks postpartum

    Maternal.

  16. Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP syndrome)

    Time frame: Up to 6 weeks postpartum

    Maternal

  17. Stillbirth

    Time frame: Up to 6 weeks postpartum

    Neonatal

  18. Neonatal Death

    Time frame: Up to 28 days after birth.

    Neonatal

  19. APGAR score <7 at 5 minutes

    Time frame: Up to 6 weeks postpartum

    Neonatal

  20. Fetal growth restriction

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  21. Low arterial cord pH at birth

    Time frame: Up to 6 weeks postpartum

    pH <7.05. Neonatal.

  22. Admission to Neonatal Intensive Care Unit (NICU)

    Time frame: Up to 6 weeks postpartum

    Neonatal

  23. Preterm birth

    Time frame: Up to 6 weeks postpartum

    Neonatal. <34 weeks gestation.

  24. Birth-related injury

    Time frame: Up to 6 weeks postpartum

    Neonatal. Including brachial plexus injury, clavicular fractures.

  25. Diagnosis of Hypoxic Ischemic Encephalopathy (HIE)

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  26. Cord prolapse

    Time frame: Up to 6 weeks postpartum

    Maternal

  27. Birth before arrival at hospital (BBA)

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  28. Breastfeeding at discharge

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  29. Low birth weight (LBW)

    Time frame: Up to 6 weeks postpartum

    Neonatal. Grams.

  30. High Birth Weight (HBW)

    Time frame: Up to 6 weeks postpartum

    Neonatal. Grams.

  31. Gestational diabetes

    Time frame: Up to 6 weeks postpartum

    Maternal.

  32. Pre-eclampsia

    Time frame: Up to 6 weeks postpartum

    Maternal.

  33. Antepartum haemorrhage

    Time frame: Up to 6 weeks postpartum.

    Maternal.

  34. Obstetric cholestasis

    Time frame: Up to 6 weeks postpartum

    Maternal.

  35. Venous thromboembolism

    Time frame: Up to 6 weeks postpartum

    Maternal.

  36. Gestational hypertension

    Time frame: Up to 6 weeks postpartum

    Maternal.

  37. Small for Gestational Age (SGA)

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  38. Large for Gestational Age (LGA)

    Time frame: Up to 6 weeks postpartum

    Neonatal.

  39. Low neonatal axillary temperature

    Time frame: Up to 6 weeks postpartum

    Neonatal. On admission. Celcius.

  40. Admitted with COVID-19, RSV, Whooping Cough or Influenza

    Time frame: Up to 6 weeks postpartum.

    Maternal.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: DIAAS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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