Emergency Maternity CareDIAASNCT07049263
Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes
An observational study of Emergency Maternity Care and Health Inequalities in Maternity Care Access, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Emergency Maternity Care, Health Inequalities in Maternity Care Access, Disparities in Access to Maternity Care
- How many people
- 18,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2024to 2 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Attended a Manchester University NHS Foundation Trust (MFT) maternity unit.
Who may be able to join
- 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.
Show all 17Show fewer
- 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
- 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
Who cannot join
- 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
- Opted out of NHS national data usage.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester
About this study
Official title: Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes [DIAAS]
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):
Read more
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.
Read the 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.
- Conditions
- Emergency Maternity Care, Health Inequalities in Maternity Care Access, Disparities in Access to Maternity Care, Deprivation, Ethnicity, Ambulances
- Keywords
- Emergency maternity care, Pre-hospital maternity care, Health disparities, Health inequalities, Perinatal period, Maternity care access, Ethnicity, Deprivation, Data linkage, Retrospective cohort study, Mixed methods, Pre-hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 weeks pospartum
Secondary outcomes (40)
Mode of birth
Maternal. Spontaneous vaginal birth, breech birth, instrumental birth (forceps, kiwi or ventouse) or Caesarean section birth.
Measured: Up to 6 weeks postpartum.
Postpartum Haemorrhage
Maternal. 500ml - 2000ml
Measured: Up to 6 weeks postpartum
Episiotomy
Maternal.
Measured: Up to 6 weeks postpartum
Length of stay in hospital after birth (maternal and neonatal)
Maternal and neonatal. Days.
Measured: Up to 6 weeks postpartum
Number of antenatal visits and ultrasound scans
Maternal.
Measured: Up to 6 weeks postpartum
Need for blood transfusion
Maternal.
Measured: Up to 6 weeks postpartum
Fetal loss <24 weeks' gestation
Maternal.
Measured: Up to 6 weeks postpartum
Maternal death
Maternal.
Measured: Up to 6 weeks postpartum
Admitted to Intensive Care Unit or High Dependency Unit
Maternal. During the perinatal period.
Measured: Up to 6 weeks postpartum
Unplanned hysterectomy
Maternal.
Measured: Up to 6 weeks postpartum
Readmission to hospital in postnatal period
Maternal.
Measured: Up to 6 weeks postpartum
Major Postpartum Haemorrhage
Maternal. >2000mls
Measured: Up to 6 weeks postpartum
Obstetric Anal Sphincter Injury (OASI)
Maternal. Third or fourth degree perineal tear.
Measured: Up to 6 weeks postpartum
Placental abruption
Maternal.
Measured: Up to 6 weeks postpartum.
Eclampsia
Maternal.
Measured: Up to 6 weeks postpartum
Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP syndrome)
Maternal
Measured: Up to 6 weeks postpartum
Stillbirth
Neonatal
Measured: Up to 6 weeks postpartum
Neonatal Death
Neonatal
Measured: Up to 28 days after birth.
APGAR score <7 at 5 minutes
Neonatal
Measured: Up to 6 weeks postpartum
Fetal growth restriction
Neonatal.
Measured: Up to 6 weeks postpartum
Low arterial cord pH at birth
pH <7.05. Neonatal.
Measured: Up to 6 weeks postpartum
Admission to Neonatal Intensive Care Unit (NICU)
Neonatal
Measured: Up to 6 weeks postpartum
Preterm birth
Neonatal. <34 weeks gestation.
Measured: Up to 6 weeks postpartum
Birth-related injury
Neonatal. Including brachial plexus injury, clavicular fractures.
Measured: Up to 6 weeks postpartum
Diagnosis of Hypoxic Ischemic Encephalopathy (HIE)
Neonatal.
Measured: Up to 6 weeks postpartum
Cord prolapse
Maternal
Measured: Up to 6 weeks postpartum
Birth before arrival at hospital (BBA)
Neonatal.
Measured: Up to 6 weeks postpartum
Breastfeeding at discharge
Neonatal.
Measured: Up to 6 weeks postpartum
Low birth weight (LBW)
Neonatal. Grams.
Measured: Up to 6 weeks postpartum
High Birth Weight (HBW)
Neonatal. Grams.
Measured: Up to 6 weeks postpartum
Gestational diabetes
Maternal.
Measured: Up to 6 weeks postpartum
Pre-eclampsia
Maternal.
Measured: Up to 6 weeks postpartum
Antepartum haemorrhage
Maternal.
Measured: Up to 6 weeks postpartum.
Obstetric cholestasis
Maternal.
Measured: Up to 6 weeks postpartum
Venous thromboembolism
Maternal.
Measured: Up to 6 weeks postpartum
Gestational hypertension
Maternal.
Measured: Up to 6 weeks postpartum
Small for Gestational Age (SGA)
Neonatal.
Measured: Up to 6 weeks postpartum
Large for Gestational Age (LGA)
Neonatal.
Measured: Up to 6 weeks postpartum
Low neonatal axillary temperature
Neonatal. On admission. Celcius.
Measured: Up to 6 weeks postpartum
Admitted with COVID-19, RSV, Whooping Cough or Influenza
Maternal.
Measured: Up to 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Sep 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion2 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Maternity CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Stephanie Heys, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049263
- Sponsor's protocol ID
- G90058
- Other IDs
- NIHR206378
- Acronym
- DIAAS
- Status last verified
- Sep 2025
- First submitted
- 20 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities In Access to the Northwest Ambulance Service During Pregnancy, Birth and Postpartum Period and Its Association With Neonatal and Maternal Outcomes [DIAAS]
- ClinicalTrials.gov ID
- NCT07049263
- Acronym / sponsor ID
- DIAAS / G90058
- Conditions
- Emergency Maternity Care, Health Inequalities in Maternity Care Access, Disparities in Access to Maternity Care, Deprivation, Ethnicity, Ambulances
- Keywords
- Emergency maternity care, Pre-hospital maternity care, Health disparities, Health inequalities, Perinatal period, Maternity care access, Ethnicity, Deprivation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 2 Jun 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Attended a Manchester University NHS Foundation Trust (MFT) maternity unit.
Key inclusion criteria (17 listed)
- North West Ambulance Service (NWAS) Cohort:
- Comparison Manchester University NHS Foundation Trust (MFT) Cohort:
- Work Package 1
- Female
- Had at least one pregnancy and/or gave birth between August 2022 to August 2024
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
40 secondary outcomes
Mode of birth
Time frame: Up to 6 weeks postpartum.
Postpartum Haemorrhage
Time frame: Up to 6 weeks postpartum
Episiotomy
Time frame: Up to 6 weeks postpartum
Length of stay in hospital after birth (maternal and neonatal)
Time frame: Up to 6 weeks postpartum
Number of antenatal visits and ultrasound scans
Time frame: Up to 6 weeks postpartum
Need for blood transfusion
Time frame: Up to 6 weeks postpartum
Fetal loss <24 weeks' gestation
Time frame: Up to 6 weeks postpartum
Maternal death
Time frame: Up to 6 weeks postpartum
Admitted to Intensive Care Unit or High Dependency Unit
Time frame: Up to 6 weeks postpartum
Unplanned hysterectomy
Time frame: Up to 6 weeks postpartum
Readmission to hospital in postnatal period
Time frame: Up to 6 weeks postpartum
Major Postpartum Haemorrhage
Time frame: Up to 6 weeks postpartum
Obstetric Anal Sphincter Injury (OASI)
Time frame: Up to 6 weeks postpartum
Placental abruption
Time frame: Up to 6 weeks postpartum.
Eclampsia
Time frame: Up to 6 weeks postpartum
Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP syndrome)
Time frame: Up to 6 weeks postpartum
Stillbirth
Time frame: Up to 6 weeks postpartum
Neonatal Death
Time frame: Up to 28 days after birth.
APGAR score <7 at 5 minutes
Time frame: Up to 6 weeks postpartum
Fetal growth restriction
Time frame: Up to 6 weeks postpartum
Low arterial cord pH at birth
Time frame: Up to 6 weeks postpartum
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Up to 6 weeks postpartum
Preterm birth
Time frame: Up to 6 weeks postpartum
Birth-related injury
Time frame: Up to 6 weeks postpartum
Diagnosis of Hypoxic Ischemic Encephalopathy (HIE)
Time frame: Up to 6 weeks postpartum
Cord prolapse
Time frame: Up to 6 weeks postpartum
Birth before arrival at hospital (BBA)
Time frame: Up to 6 weeks postpartum
Breastfeeding at discharge
Time frame: Up to 6 weeks postpartum
Low birth weight (LBW)
Time frame: Up to 6 weeks postpartum
High Birth Weight (HBW)
Time frame: Up to 6 weeks postpartum
Gestational diabetes
Time frame: Up to 6 weeks postpartum
Pre-eclampsia
Time frame: Up to 6 weeks postpartum
Antepartum haemorrhage
Time frame: Up to 6 weeks postpartum.
Obstetric cholestasis
Time frame: Up to 6 weeks postpartum
Venous thromboembolism
Time frame: Up to 6 weeks postpartum
Gestational hypertension
Time frame: Up to 6 weeks postpartum
Small for Gestational Age (SGA)
Time frame: Up to 6 weeks postpartum
Large for Gestational Age (LGA)
Time frame: Up to 6 weeks postpartum
Low neonatal axillary temperature
Time frame: Up to 6 weeks postpartum
Admitted with COVID-19, RSV, Whooping Cough or Influenza
Time frame: Up to 6 weeks postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Maternity Care and Health Inequalities in Maternity Care Access, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe neonatal morbidity (composite) (time frame: Up to 6 weeks postpartum.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.