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
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Treatment: Referral to high level of care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Treatment: Referral to high level of care
时间窗: In-hospital censored at 30 days
Binary: Whether or not referral to higher level of care took place
Treatment: Surgical safety checklist
时间窗: 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
时间窗: 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
时间窗: On the day of hospital admission
Binary: Obstetrician opinion whether there was a clinically important delay in transport
Transport: Distance
时间窗: On the day of hospital admission
Continuous: distance in kilometers from patient's home to hospital
Treatment: Therapeutic uterotonic use
时间窗: On day of caesarean section, at time of caesarean section
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Transport: Mode of transport
时间窗: On the day of hospital admission
Nominal: walking, private transport, ambulance, public transport
Transport: Time
时间窗: On the day of hospital admission
Continuous: time in hours from patient's home to hospital
Transport: Inter-facility delay
时间窗: 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
时间窗: On day of caesarean section
Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Treatment: Availability of monitoring equipment
时间窗: 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
时间窗: 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
时间窗: On day of caesarean section
Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Treatment: Desaturation
时间窗: 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
时间窗: 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
时间窗: On day of caesarean section
Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
Treatment: Access to hospital resources
时间窗: 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
时间窗: On day of caesarean section, at time of caesarean section
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Spinal hypotension
时间窗: On day of caesarean section, at time of caesarean section
Binary: Whether or not spinal hypotension occured; systolic BP \<= 90mmHg
Training: Level of training
时间窗: 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
时间窗: On day of caesarean section, at time of caesarean section
Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Treatment: Airway aspiration
时间窗: On day of caesarean section, at time of caesarean section
Binary: Whether or not airway aspiration occurred
Treatment: Interventions to arrest bleeding
时间窗: 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
时间窗: 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
时间窗: On day of caesarean section
Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Treatment: Availability of blood products
时间窗: On day of caesarean section
Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
次要结局
- Cause of death(Maternal death is recorded in-hospital, censored at 30 days.)
研究者
Bruce Biccard
Professor
University of Cape Town