Maternal MortalityNCT04029207
The ASOS-2 Trial Maternal Mortality Sub-study
An observational study of Maternal Mortality and Cesarean Section, run by University of Cape Town at 1 site in South Africa.
Trial summary
This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Mortality, Cesarean Section, Africa
- What is being tested?
- Cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- 6 May 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.
Who may be able to join
- adult patients
- aged 18 years and over,
- admitted to participating hospitals
- undergoing elective and non-elective caesarean delivery
- who die following their operation before leaving hospital and within 30 days after the operation.
Who cannot join
- prior participation in ASOS-2
- caesarean delivery at a hospital other than the study hospital (left censored)
- patients who are transferred to another hospital before death (right censored)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Groote Schuur Hospital
Observatory, Western Cape, 7925
About this study
Official title: The African Surgical OutcomeS-2 (ASOS-2) Trial Maternal Mortality Sub-study. A Mixed-methods Analysis of a Prospective Case-series Describing Factors Contributing to Maternal Mortality Associated With Caesarean Delivery in Africa
This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.
Read the detailed description
This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. When a maternal death is captured on the trial database, the data manager will flag the event. The hospital that registered the death will be contacted and invited to take part in the sub-study. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.
This study uses 2 a priori frameworks for describing maternal deaths:
- The "transport-treatment-training" framework developed by Dr Andrew Shennan (personal communication). This framework suggests that the important determinants (modifiable contextual factors) of maternal mortality can be classified as being related to transport, treatment and training factors.
- Transport refers to the manner in which the patient accesses existing care. This includes decision to seek help, modes of transportation to the hospital, and inter-facility transportation. We consider the healthcare access network in this category.
- Treatment refers to the manner in which the case was managed at the healthcare facility. It includes delays in diagnosis and decision making as well as delays between decision making and physical intervention (e.g. time from decision for caesarean delivery to time of delivery of the infant). Treatment also includes appropriateness of treatment decisions and the availability of resources needed to provide recommended treatment.
- Training refers to the availability of skilled health care providers and the need for training / upskilling of existing health care providers. ii) The WHO application of ICD-10 codes to deaths during pregnancy, childbirth and puerperium (ICD MM) classification. Within this framework, deaths are described as having a final direct cause, an underlying cause that leads to the final cause, and contributory causes that did not directly cause death, but worsened physiological status or accelerated the underlying event.
The underlying cause of death is defined as the disease or condition that initiated the morbid chain of events leading to death or the circumstances of the accident or violence that produced a fatal injury. Underlying causes will be specified in as much detail as available. The underlying cause will be classified into one of 8 categories:
- Hypertensive disorders in pregnancy
- Obstetric haemorrhage
- Pregnancy-related infection
- Other obstetric complications
- Unanticipated complications of management (iatrogenic)
- Non-obstetric complications (non-obstetric disease, e.g. cardiac disease, malaria)
- Unknown / Undetermined
- Coincidental external causes (e.g. interpersonal violence)
- Conditions
- Maternal Mortality, Cesarean Section, Africa
- Being tested
- Cesarean section
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean sectionProcedure or surgery
Abdominal, operative delivery of the fetus
| Study group | Role | What they receive |
|---|---|---|
| African Surgical OutcomeS-2 Trial | The ASOS-2 Trial is a cluster randomised trial purposively recruiting hospitals across Africa. To be eligible for inclusion a hospital must perform at least 20 cases of adult in-patient surgery with anaesthesia per week, have local ethics approval for the trial, have local hospital management approval and have established a local hospital study team. The trial excludes hospitals with lower surgical volume. The trial aims to include all consecutive adult in-patient surgical cases at participating hospitals (both elective and emergency surgery). Patients under the age of 18 and patients who have already been recruited into the trial are excluded from recruitment. Follow-up is in-hospital, censored at 30 days. Receives: Procedure: Cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transport: Mode of transport
Nominal: walking, private transport, ambulance, public transport
Measured: On the day of hospital admission
Transport: Distance
Continuous: distance in kilometers from patient's home to hospital
Measured: On the day of hospital admission
Transport: Time
Continuous: time in hours from patient's home to hospital
Measured: On the day of hospital admission
Transport: Delay in seeking healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in seeking care
Measured: On the day of hospital admission
Transport: Delay in transport to healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in transport
Measured: On the day of hospital admission
Transport: Inter-facility delay
Binary: Did the patient die while waiting for inter-facility transfer?
Measured: At time of death (death recorded in-hospital, censored at 30 days)
Treatment: Referral to high level of care
Binary: Whether or not referral to higher level of care took place
Measured: In-hospital censored at 30 days
Treatment: Prophylactic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Measured: On day of caesarean section, at time of caesarean section
Treatment: Therapeutic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Measured: On day of caesarean section, at time of caesarean section
Treatment: Surgical safety checklist
Binary: Whether or not a surgical safety checklist was used
Measured: On day of caesarean section, at time of caesarean section
Treatment: Type of anaesthetic
Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Measured: On day of caesarean section, at time of caesarean section
Treatment: Airway aspiration
Binary: Whether or not airway aspiration occurred
Measured: On day of caesarean section, at time of caesarean section
Treatment: Desaturation
Binary: Whether or not desaturation below 90% occurred during management of the airway
Measured: On day of caesarean section, at time of caesarean section
Treatment: Spinal hypotension
Binary: Whether or not spinal hypotension occured; systolic BP <= 90mmHg
Measured: On day of caesarean section, at time of caesarean section
Treatment: Interventions to arrest bleeding
Nominal: Which techniques were used? over-sowing, uterine compression suture, uterine artery ligation, uterine tourniquet, intrauterine balloon, hysterectomy, uterine artery embolisation
Measured: In hospital, censored at 30 days
Treatment: Blood products
Nominal: Which products were given? Red blood cells, fresh frozen plasma, freeze dried plasma, cryoprecipitate, platelets, whole blood.
Measured: In hospital, censored at 30 days
Treatment: Availability of medications
Nominal: Oxygen, Propofol, Thiopentone, Etomidate, Ketamine, Suxamethonium, Rocuronium, Nitrous Oxide, Halothane, Isoflurane, Sevoflurane, Oxytocin, Ergometrine, Syntometrine, Misoprostil, Prostaglandin F2alpha, Carbetocin, Phenylephrine, Ephedrine, Adrenalin, Noradrenalin, Morphine, Fentanyl, Pethidine, Lignocaine, Bupivacaine, Tranexamic Acid
Measured: On day of caesarean section
Treatment: Availability of blood products
Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
Measured: On day of caesarean section
Treatment: Availability of resuscitation equipment
Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Measured: On day of caesarean section
Treatment: Availability of monitoring equipment
Nominal: Which monitoring equipment are available in the recovery area and the postoperative ward? O2 saturation, blood pressure, heart rate monitor, thermometer
Measured: On day of caesarean section
Treatment: Recovery area
Binary: Is there a dedicated area where the patient is monitored during recovery from anaesthesia for caesarean section?
Measured: On day of caesarean section
Treatment: Provider-patient ratio
Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Measured: On day of caesarean section
Treatment: Delay in diagnosis
Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Measured: On day of caesarean section
Treatment: Delay between diagnosis and caesarean section
Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
Measured: On day of caesarean section
Treatment: Access to hospital resources
Nominal: Obstetrician opinion whether delayed access or lack of hospital resources contributed to the death: water supply, electricity, medications, telephone, anaesthetic equipment, surgical equipment, monitoring equipment, operating theatre, nursing or assistant, on-call senior obstetric doctor, on-call senior anaesthetic doctor, advice from referral center.
Measured: On day of caesarean section
Training: Level of training
Nominal: Provider level of training at caesarean seciton (for anaesthesia and surgery): Specialist, specialist trainee, non-specialist doctor, non-doctor
Measured: At time of caesarean section
Secondary outcomes (1)
Cause of death
WHO ICD-10 maternal mortality reporting standard
Measured: Maternal death is recorded in-hospital, censored at 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start6 May 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal MortalityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Bruce Biccard, University of Cape Town
- Investigators
- Professor Bruce M Biccard, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029207
- Sponsor's protocol ID
- ASOS-2 Maternal Mortality
- Status last verified
- Jan 2020
- First submitted
- 25 Jun 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Principle Investigator will receive requests to share individual participant data and will decide on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The African Surgical OutcomeS-2 (ASOS-2) Trial Maternal Mortality Sub-study. A Mixed-methods Analysis of a Prospective Case-series Describing Factors Contributing to Maternal Mortality Associated With Caesarean Delivery in Africa
- ClinicalTrials.gov ID
- NCT04029207
- Acronym / sponsor ID
- ASOS-2 Maternal Mortality
- Conditions
- Maternal Mortality, Cesarean Section, Africa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 6 May 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 23 Jul 2019 (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 sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.
Detailed description
This sub-study is a mixed-methods analysis of a prospective case-series of maternal deaths within the African Surgical OutcomeS-2 trial cohort. The aims of the sub-study are i) to describe the contextual factors that contribute towards maternal deaths after caesarean delivery in Africa using a conceptual framework of "transport-treatment-training" and ii) to classify the maternal deaths in the ASOS-2 trial according to the WHO ICD-10 maternal mortality reporting standard. Data will be extracted from the ASOS-2 trial database. When a maternal death is captured on the trial database, the data manager will flag the event. The hospital that registered the death will be contacted and invited to take part in the sub-study. A sub-study case report form (CRF) and semi-structured telephonic interviews will be used to gather additional information from clinicians who were experienced a maternal death during the trial.
This study uses 2 a priori frameworks for describing maternal deaths:
- The "transport-treatment-training" framework developed by Dr Andrew Shennan (personal communication). This framework suggests that the important determinants (modifiable contextual factors) of maternal mortality can be classified as being related to transport, treatment and training factors.
- Transport refers to the manner in which the patient accesses existing care. This includes decision to seek help, modes of transportation to the hospital, and inter-facility transportation. We consider the healthcare access network in this category.
- Treatment refers to the manner in which the case was managed at the healthcare facility. It includes delays in diagnosis and decision making as well as delays between decision making and physical intervention (e.g. time from decision for caesarean delivery to time of delivery of the infant). Treatment also includes appropriateness of treatment decisions and the availability of resources needed to provide recommended treatment.
- Training refers to the availability of skilled health care providers and the need for training / upskilling of existing health care providers. ii) The WHO application of ICD-10 codes to deaths during pregnancy, childbirth and puerperium (ICD MM) classification. Within this framework, deaths are described as having a final direct cause, an underlying cause that leads to the final cause, and contributory causes that did not directly cause death, but worsened physiological status or accelerated the underlying event.
The underlying cause of death is defined as the disease or condition that initiated the morbid chain of events leading to death or the circumstances of the accident or violence that produced a fatal injury. Underlying causes will be specified in as much detail as available. The underlying cause will be classified into one of 8 categories:
- Hypertensive disorders in pregnancy
- Obstetric haemorrhage
- Pregnancy-related infection
- Other obstetric complications
- Unanticipated complications of management (iatrogenic)
- Non-obstetric complications (non-obstetric disease, e.g. cardiac disease, malaria)
- Unknown / Undetermined
- Coincidental external causes (e.g. interpersonal violence)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African Surgical OutcomeS-2 Trial | – | Procedure: Cesarean sectionThe ASOS-2 Trial is a cluster randomised trial purposively recruiting hospitals across Africa. To be eligible for inclusion a hospital must perform at least 20 cases of adult in-patient surgery with anaesthesia per week, have local ethics approval for the trial, have local hospital management approval and have established a local hospital study team. The trial excludes hospitals with lower surgical volume. The trial aims to include all consecutive adult in-patient surgical cases at participating hospitals (both elective and emergency surgery). Patients under the age of 18 and patients who have already been recruited into the trial are excluded from recruitment. Follow-up is in-hospital, censored at 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.
Key inclusion criteria (5 listed)
- adult patients
- aged 18 years and over,
- admitted to participating hospitals
- undergoing elective and non-elective caesarean delivery
- who die following their operation before leaving hospital and within 30 days after the operation.
Key exclusion criteria (3 listed)
- prior participation in ASOS-2
- caesarean delivery at a hospital other than the study hospital (left censored)
- patients who are transferred to another hospital before death (right censored)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean sectionAbdominal, operative delivery of the fetus | Procedure or surgery | African Surgical OutcomeS-2 Trial |
Primary outcome
Transport: Mode of transport
Time frame: On the day of hospital admission
Nominal: walking, private transport, ambulance, public transport
Transport: Distance
Time frame: On the day of hospital admission
Continuous: distance in kilometers from patient's home to hospital
Transport: Time
Time frame: On the day of hospital admission
Continuous: time in hours from patient's home to hospital
Transport: Delay in seeking healthcare
Time frame: On the day of hospital admission
Binary: Obstetrician opinion whether there was a clinically important delay in seeking care
Transport: Delay in transport to healthcare
Time frame: On the day of hospital admission
Binary: Obstetrician opinion whether there was a clinically important delay in transport
Transport: Inter-facility delay
Time frame: At time of death (death recorded in-hospital, censored at 30 days)
Binary: Did the patient die while waiting for inter-facility transfer?
Treatment: Referral to high level of care
Time frame: In-hospital censored at 30 days
Binary: Whether or not referral to higher level of care took place
Treatment: Prophylactic uterotonic use
Time frame: On day of caesarean section, at time of caesarean section
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Therapeutic uterotonic use
Time frame: On day of caesarean section, at time of caesarean section
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Surgical safety checklist
Time frame: On day of caesarean section, at time of caesarean section
Binary: Whether or not a surgical safety checklist was used
Treatment: Type of anaesthetic
Time frame: On day of caesarean section, at time of caesarean section
Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Treatment: Airway aspiration
Time frame: On day of caesarean section, at time of caesarean section
Binary: Whether or not airway aspiration occurred
Treatment: Desaturation
Time frame: On day of caesarean section, at time of caesarean section
Binary: Whether or not desaturation below 90% occurred during management of the airway
Treatment: Spinal hypotension
Time frame: On day of caesarean section, at time of caesarean section
Binary: Whether or not spinal hypotension occured; systolic BP <= 90mmHg
Treatment: Interventions to arrest bleeding
Time frame: In hospital, censored at 30 days
Nominal: Which techniques were used? over-sowing, uterine compression suture, uterine artery ligation, uterine tourniquet, intrauterine balloon, hysterectomy, uterine artery embolisation
Treatment: Blood products
Time frame: In hospital, censored at 30 days
Nominal: Which products were given? Red blood cells, fresh frozen plasma, freeze dried plasma, cryoprecipitate, platelets, whole blood.
Treatment: Availability of medications
Time frame: On day of caesarean section
Nominal: Oxygen, Propofol, Thiopentone, Etomidate, Ketamine, Suxamethonium, Rocuronium, Nitrous Oxide, Halothane, Isoflurane, Sevoflurane, Oxytocin, Ergometrine, Syntometrine, Misoprostil, Prostaglandin F2alpha, Carbetocin, Phenylephrine, Ephedrine, Adrenalin, Noradrenalin, Morphine, Fentanyl, Pethidine, Lignocaine, Bupivacaine, Tranexamic Acid
Treatment: Availability of blood products
Time frame: On day of caesarean section
Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
Treatment: Availability of resuscitation equipment
Time frame: On day of caesarean section
Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Treatment: Availability of monitoring equipment
Time frame: On day of caesarean section
Nominal: Which monitoring equipment are available in the recovery area and the postoperative ward? O2 saturation, blood pressure, heart rate monitor, thermometer
Treatment: Recovery area
Time frame: On day of caesarean section
Binary: Is there a dedicated area where the patient is monitored during recovery from anaesthesia for caesarean section?
Treatment: Provider-patient ratio
Time frame: On day of caesarean section
Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Treatment: Delay in diagnosis
Time frame: On day of caesarean section
Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Treatment: Delay between diagnosis and caesarean section
Time frame: On day of caesarean section
Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
Treatment: Access to hospital resources
Time frame: On day of caesarean section
Nominal: Obstetrician opinion whether delayed access or lack of hospital resources contributed to the death: water supply, electricity, medications, telephone, anaesthetic equipment, surgical equipment, monitoring equipment, operating theatre, nursing or assistant, on-call senior obstetric doctor, on-call senior anaesthetic doctor, advice from referral center.
Training: Level of training
Time frame: At time of caesarean section
Nominal: Provider level of training at caesarean seciton (for anaesthesia and surgery): Specialist, specialist trainee, non-specialist doctor, non-doctor
1 secondary outcome
Cause of death
Time frame: Maternal death is recorded in-hospital, censored at 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: Undecided. The Principle Investigator will receive requests to share individual participant data and will decide on a case by case basis.
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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.
Professor Bruce M Biccard principal investigator
University of Cape Town
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 Maternal Mortality and Cesarean Section, run by University of Cape Town at 1 site in South Africa.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. 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 South Africa. 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?
Results are not available in the source record.
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?
Transport: Mode of transport (time frame: On the day of hospital admission). The study lists 26 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 29 Jan 2020.