Manchester University NHS Foundation Trust
Manchester, United Kingdom
NCT Number: NCT07049263
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.
This study is active but is not currently recruiting participants.
Notify MeFemale
Observational
Manchester, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Work Package 1
Inclusion criteria
Work Package 1
Exclusion criteria
Work Package 2
Inclusion criteria
Work Package 2
Exclusion criteria
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.
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.
Time frame: Up to 6 weeks postpartum.
Maternal. Spontaneous vaginal birth, breech birth, instrumental birth (forceps, kiwi or ventouse) or Caesarean section birth.
Time frame: Up to 6 weeks postpartum
Maternal. 500ml - 2000ml
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal and neonatal. Days.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal. During the perinatal period.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal. >2000mls
Time frame: Up to 6 weeks postpartum
Maternal. Third or fourth degree perineal tear.
Time frame: Up to 6 weeks postpartum.
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal
Time frame: Up to 6 weeks postpartum
Neonatal
Time frame: Up to 28 days after birth.
Neonatal
Time frame: Up to 6 weeks postpartum
Neonatal
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
pH <7.05. Neonatal.
Time frame: Up to 6 weeks postpartum
Neonatal
Time frame: Up to 6 weeks postpartum
Neonatal. <34 weeks gestation.
Time frame: Up to 6 weeks postpartum
Neonatal. Including brachial plexus injury, clavicular fractures.
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
Maternal
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
Neonatal. Grams.
Time frame: Up to 6 weeks postpartum
Neonatal. Grams.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum.
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Maternal.
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
Neonatal.
Time frame: Up to 6 weeks postpartum
Neonatal. On admission. Celcius.
Time frame: Up to 6 weeks postpartum.
Maternal.
Manchester University NHS Foundation Trust
Other Gov
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
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.
Published trials that share one or more normalized conditions with this study.
NCT07672054
Behavior, Behavior, Animal
Derby, United Kingdom
View Trial DetailsNCT06905613
Ambulances, Technical Feasibility
Uppsala, Uppsala County, Sweden
View Trial DetailsNCT07472335
Acute Disease, Aged
Gothenburg, Sweden
View Trial DetailsNCT06460090
Behavior, Communication
Dublin, Ireland
View Trial Details