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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cesarean section | Procedure | Abdominal, operative delivery of the fetus |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cause of death | WHO ICD-10 maternal mortality reporting standard | Maternal death is recorded in-hospital, censored at 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.
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| Name | Affiliation | Role |
|---|---|---|
| Professor Bruce M Biccard | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groote Schuur Hospital | Observatory | Western Cape | 7925 | South Africa |
The Principle Investigator will receive requests to share individual participant data and will decide on a case by case basis.
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| ID | Term |
|---|---|
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |