The ASOS-2 Trial Maternal Mortality Sub-study

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04029207
• Other study ID #: ASOS-2 Maternal Mortality
• Status: Enrolling by invitation
• Start date: May 6, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: January 2020
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Africa
• Cesarean Section
• Maternal Death
• Maternal Mortality

Intervention

Procedure:
• Cesarean section
Abdominal, operative delivery of the fetus

Locations

Country	Name	City	State
South Africa	Groote Schuur Hospital	Observatory	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transport: Mode of transport	Nominal: walking, private transport, ambulance, public transport	On the day of hospital admission
Primary	Transport: Distance	Continuous: distance in kilometers from patient's home to hospital	On the day of hospital admission
Primary	Transport: Time	Continuous: time in hours from patient's home to hospital	On the day of hospital admission
Primary	Transport: Delay in seeking healthcare	Binary: Obstetrician opinion whether there was a clinically important delay in seeking care	On the day of hospital admission
Primary	Transport: Delay in transport to healthcare	Binary: Obstetrician opinion whether there was a clinically important delay in transport	On the day of hospital admission
Primary	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)
Primary	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
Primary	Treatment: Prophylactic uterotonic use	Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None	On day of caesarean section, at time of caesarean section
Primary	Treatment: Therapeutic uterotonic use	Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None	On day of caesarean section, at time of caesarean section
Primary	Treatment: Surgical safety checklist	Binary: Whether or not a surgical safety checklist was used	On day of caesarean section, at time of caesarean section
Primary	Treatment: Type of anaesthetic	Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.	On day of caesarean section, at time of caesarean section
Primary	Treatment: Airway aspiration	Binary: Whether or not airway aspiration occurred	On day of caesarean section, at time of caesarean section
Primary	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
Primary	Treatment: Spinal hypotension	Binary: Whether or not spinal hypotension occured; systolic BP <= 90mmHg	On day of caesarean section, at time of caesarean section
Primary	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
Primary	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
Primary	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
Primary	Treatment: Availability of blood products	Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate	On day of caesarean section
Primary	Treatment: Availability of resuscitation equipment	Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,	On day of caesarean section
Primary	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
Primary	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
Primary	Treatment: Provider-patient ratio	Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)	On day of caesarean section
Primary	Treatment: Delay in diagnosis	Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred	On day of caesarean section
Primary	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
Primary	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
Primary	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
Secondary	Cause of death	WHO ICD-10 maternal mortality reporting standard	Maternal death is recorded in-hospital, censored at 30 days.