The ASOS-2 Trial Maternal Mortality Sub-study
- Conditions
- Maternal MortalityAfricaCesarean Section
- Interventions
- Procedure: Cesarean section
- Registration Number
- NCT04029207
- Lead Sponsor
- University of Cape Town
- 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.
- 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:
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:
1. Hypertensive disorders in pregnancy
2. Obstetric haemorrhage
3. Pregnancy-related infection
4. Other obstetric complications
5. Unanticipated complications of management (iatrogenic)
6. Non-obstetric complications (non-obstetric disease, e.g. cardiac disease, malaria)
7. Unknown / Undetermined
8. Coincidental external causes (e.g. interpersonal violence)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description African Surgical OutcomeS-2 Trial Cesarean section 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.
- Primary Outcome Measures
Name Time Method Treatment: Referral to high level of care In-hospital censored at 30 days Binary: Whether or not referral to higher level of care took place
Treatment: Surgical safety checklist On day of caesarean section, at time of caesarean section Binary: Whether or not a surgical safety checklist was used
Transport: Delay in seeking healthcare 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 On the day of hospital admission Binary: Obstetrician opinion whether there was a clinically important delay in transport
Transport: Distance On the day of hospital admission Continuous: distance in kilometers from patient's home to hospital
Treatment: Therapeutic uterotonic use On day of caesarean section, at time of caesarean section Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Transport: Mode of transport On the day of hospital admission Nominal: walking, private transport, ambulance, public transport
Transport: Time On the day of hospital admission Continuous: time in hours from patient's home to hospital
Transport: Inter-facility delay At time of death (death recorded in-hospital, censored at 30 days) Binary: Did the patient die while waiting for inter-facility transfer?
Treatment: Availability of resuscitation equipment On day of caesarean section Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Treatment: Availability of monitoring equipment 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 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 On day of caesarean section Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Treatment: Desaturation On day of caesarean section, at time of caesarean section Binary: Whether or not desaturation below 90% occurred during management of the airway
Treatment: Blood products 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: Delay between diagnosis and caesarean section On day of caesarean section Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
Treatment: Access to hospital resources 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.
Treatment: Prophylactic uterotonic use On day of caesarean section, at time of caesarean section Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Spinal hypotension On day of caesarean section, at time of caesarean section Binary: Whether or not spinal hypotension occured; systolic BP \<= 90mmHg
Training: Level of training 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
Treatment: Type of anaesthetic On day of caesarean section, at time of caesarean section Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Treatment: Airway aspiration On day of caesarean section, at time of caesarean section Binary: Whether or not airway aspiration occurred
Treatment: Interventions to arrest bleeding 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: Availability of medications 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: Delay in diagnosis On day of caesarean section Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Treatment: Availability of blood products On day of caesarean section Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
- Secondary Outcome Measures
Name Time Method Cause of death Maternal death is recorded in-hospital, censored at 30 days. WHO ICD-10 maternal mortality reporting standard
Trial Locations
- Locations (1)
Groote Schuur Hospital
🇿🇦Observatory, Western Cape, South Africa