An observational study in Maternal Mortality, Cesarean Section and Africa, sponsored by University of Cape Town. Status unknown at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by University of Cape Town · Observational
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:
African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.
Exclusion Criteria:
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
Abdominal, operative delivery of the fetus
Transport: Mode of transport
Nominal: walking, private transport, ambulance, public transport
Time frame: On the day of hospital admission
Transport: Distance
Continuous: distance in kilometers from patient's home to hospital
Time frame: On the day of hospital admission
Transport: Time
Continuous: time in hours from patient's home to hospital
Time frame: On the day of hospital admission
Transport: Delay in seeking healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in seeking care
Time frame: On the day of hospital admission
Transport: Delay in transport to healthcare
Binary: Obstetrician opinion whether there was a clinically important delay in transport
Time frame: On the day of hospital admission
Transport: Inter-facility delay
Binary: Did the patient die while waiting for inter-facility transfer?
Time frame: 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
Time frame: In-hospital censored at 30 days
Treatment: Prophylactic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Time frame: On day of caesarean section, at time of caesarean section
Treatment: Therapeutic uterotonic use
Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
Time frame: On day of caesarean section, at time of caesarean section
Treatment: Surgical safety checklist
Binary: Whether or not a surgical safety checklist was used
Time frame: On day of caesarean section, at time of caesarean section
Treatment: Type of anaesthetic
Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
Time frame: On day of caesarean section, at time of caesarean section
Treatment: Airway aspiration
Binary: Whether or not airway aspiration occurred
Time frame: 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
Time frame: On day of caesarean section, at time of caesarean section
Treatment: Spinal hypotension
Binary: Whether or not spinal hypotension occured; systolic BP \<= 90mmHg
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: On day of caesarean section
Treatment: Availability of blood products
Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
Time frame: On day of caesarean section
Treatment: Availability of resuscitation equipment
Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
Time frame: 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
Time frame: 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?
Time frame: On day of caesarean section
Treatment: Provider-patient ratio
Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
Time frame: On day of caesarean section
Treatment: Delay in diagnosis
Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: At time of caesarean section
Cause of death
WHO ICD-10 maternal mortality reporting standard
Time frame: Maternal death is recorded in-hospital, censored at 30 days.
Plan to share: Undecided — The Principle Investigator will receive requests to share individual participant data and will decide on a case by case basis.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Cape Town