The ASOS-2 Trial Maternal Mortality Sub-study

Study Overview
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Brief Summary
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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
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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: i) 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)

Official Title
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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

Conditions
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Maternal Mortality, Cesarean Section, Africa

Intervention / Treatment
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* Procedure: Cesarean section


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| African Surgical OutcomeS-2 Trial<br>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. | Procedure: Cesarean section<br>* Abdominal, operative delivery of the fetus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause of death | WHO ICD-10 maternal mortality reporting standard | Maternal death is recorded in-hospital, censored at 30 days. |