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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04029207
Enrollment
100
Registered
2019-07-23
Start date
2019-05-06
Completion date
2020-07-31
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Africa, Cesarean Section, Maternal Mortality

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)

Interventions

PROCEDURECesarean section

Abdominal, operative delivery of the fetus

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
University of Cape Town
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Training: Level of trainingAt time of caesarean sectionNominal: Provider level of training at caesarean seciton (for anaesthesia and surgery): Specialist, specialist trainee, non-specialist doctor, non-doctor
Treatment: Airway aspirationOn day of caesarean section, at time of caesarean sectionBinary: Whether or not airway aspiration occurred
Treatment: DesaturationOn day of caesarean section, at time of caesarean sectionBinary: Whether or not desaturation below 90% occurred during management of the airway
Treatment: Spinal hypotensionOn day of caesarean section, at time of caesarean sectionBinary: Whether or not spinal hypotension occured; systolic BP \<= 90mmHg
Transport: Mode of transportOn the day of hospital admissionNominal: walking, private transport, ambulance, public transport
Transport: DistanceOn the day of hospital admissionContinuous: distance in kilometers from patient's home to hospital
Transport: TimeOn the day of hospital admissionContinuous: time in hours from patient's home to hospital
Transport: Delay in seeking healthcareOn the day of hospital admissionBinary: Obstetrician opinion whether there was a clinically important delay in seeking care
Transport: Delay in transport to healthcareOn the day of hospital admissionBinary: Obstetrician opinion whether there was a clinically important delay in transport
Treatment: Therapeutic uterotonic useOn day of caesarean section, at time of caesarean sectionNominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Surgical safety checklistOn day of caesarean section, at time of caesarean sectionBinary: Whether or not a surgical safety checklist was used
Treatment: Type of anaestheticOn day of caesarean section, at time of caesarean sectionNominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Transport: Inter-facility delayAt time of death (death recorded in-hospital, censored at 30 days)Binary: Did the patient die while waiting for inter-facility transfer?
Treatment: Referral to high level of careIn-hospital censored at 30 daysBinary: Whether or not referral to higher level of care took place
Treatment: Prophylactic uterotonic useOn day of caesarean section, at time of caesarean sectionNominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Treatment: Interventions to arrest bleedingIn hospital, censored at 30 daysNominal: Which techniques were used? over-sowing, uterine compression suture, uterine artery ligation, uterine tourniquet, intrauterine balloon, hysterectomy, uterine artery embolisation
Treatment: Blood productsIn hospital, censored at 30 daysNominal: Which products were given? Red blood cells, fresh frozen plasma, freeze dried plasma, cryoprecipitate, platelets, whole blood.
Treatment: Availability of medicationsOn day of caesarean sectionNominal: 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: Availability of blood productsOn day of caesarean sectionNominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
Treatment: Availability of resuscitation equipmentOn day of caesarean sectionNominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Treatment: Availability of monitoring equipmentOn day of caesarean sectionNominal: Which monitoring equipment are available in the recovery area and the postoperative ward? O2 saturation, blood pressure, heart rate monitor, thermometer
Treatment: Recovery areaOn day of caesarean sectionBinary: Is there a dedicated area where the patient is monitored during recovery from anaesthesia for caesarean section?
Treatment: Provider-patient ratioOn day of caesarean sectionInterval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Treatment: Delay in diagnosisOn day of caesarean sectionBinary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Treatment: Delay between diagnosis and caesarean sectionOn day of caesarean sectionBinary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
Treatment: Access to hospital resourcesOn day of caesarean sectionNominal: 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.

Secondary

MeasureTime frameDescription
Cause of deathMaternal death is recorded in-hospital, censored at 30 days.WHO ICD-10 maternal mortality reporting standard

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026