The ASOS-2 Trial Maternal Mortality Sub-study
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
1 other identifier
observational
100
1 country
1
Brief 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 "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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started May 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2019
CompletedFirst Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedJanuary 29, 2020
January 1, 2020
1.2 years
June 25, 2019
January 27, 2020
Conditions
Outcome Measures
Primary Outcomes (26)
Transport: Mode of transport
Nominal: walking, private transport, ambulance, public transport
On the day of hospital admission
Transport: Distance
Continuous: distance in kilometers from patient's home to hospital
On the day of hospital admission
Transport: Time
Continuous: time in hours from patient's home to hospital
On the day of hospital admission
Transport: Delay in seeking healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in seeking care
On the day of hospital admission
Transport: Delay in transport to healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in transport
On the day of hospital admission
Transport: Inter-facility delay
Binary: Did the patient die while waiting for inter-facility transfer?
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
In-hospital censored at 30 days
Treatment: Prophylactic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
On day of caesarean section, at time of caesarean section
Treatment: Therapeutic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
On day of caesarean section, at time of caesarean section
Treatment: Surgical safety checklist
Binary: Whether or not a surgical safety checklist was used
On day of caesarean section, at time of caesarean section
Treatment: Type of anaesthetic
Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
On day of caesarean section, at time of caesarean section
Treatment: Airway aspiration
Binary: Whether or not airway aspiration occurred
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
On day of caesarean section, at time of caesarean section
Treatment: Spinal hypotension
Binary: Whether or not spinal hypotension occured; systolic BP \<= 90mmHg
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
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.
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
On day of caesarean section
Treatment: Availability of blood products
Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
On day of caesarean section
Treatment: Availability of resuscitation equipment
Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
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
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?
On day of caesarean section
Treatment: Provider-patient ratio
Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
On day of caesarean section
Treatment: Delay in diagnosis
Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
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
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.
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
At time of caesarean section
Secondary Outcomes (1)
Cause of death
Maternal death is recorded in-hospital, censored at 30 days.
Study Arms (1)
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.
Interventions
Abdominal, operative delivery of the fetus
Eligibility Criteria
African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cape Townlead
- Bill and Melinda Gates Foundationcollaborator
Study Sites (1)
Groote Schuur Hospital
Observatory, Western Cape, 7925, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor Bruce M Biccard
University of Cape Town
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 25, 2019
First Posted
July 23, 2019
Study Start
May 6, 2019
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
January 29, 2020
Record last verified: 2020-01