Clinical trial NCT04029207: The ASOS-2 Trial Maternal Mortality Sub-study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal Mortality
Cesarean Section
Africa
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2019-07-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African mothers who die during or after caesarean delivery. The primary study is a cluster randomised trial which samples hospitals across Africa purposively.

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Transport: Mode of transport
timeFrame: On the day of hospital admission
measure: Transport: Distance
timeFrame: On the day of hospital admission
measure: Transport: Time
timeFrame: On the day of hospital admission
measure: Transport: Delay in seeking healthcare
timeFrame: On the day of hospital admission
measure: Transport: Delay in transport to healthcare
timeFrame: On the day of hospital admission
measure: Transport: Inter-facility delay
timeFrame: At time of death (death recorded in-hospital, censored at 30 days)
measure: Treatment: Referral to high level of care
timeFrame: In-hospital censored at 30 days
measure: Treatment: Prophylactic uterotonic use
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Therapeutic uterotonic use
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Surgical safety checklist
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Type of anaesthetic
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Airway aspiration
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Desaturation
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Spinal hypotension
timeFrame: On day of caesarean section, at time of caesarean section
measure: Treatment: Interventions to arrest bleeding
timeFrame: In hospital, censored at 30 days
measure: Treatment: Blood products
timeFrame: In hospital, censored at 30 days
measure: Treatment: Availability of medications
timeFrame: On day of caesarean section
measure: Treatment: Availability of blood products
timeFrame: On day of caesarean section
measure: Treatment: Availability of resuscitation equipment
timeFrame: On day of caesarean section
measure: Treatment: Availability of monitoring equipment
timeFrame: On day of caesarean section
measure: Treatment: Recovery area
timeFrame: On day of caesarean section
measure: Treatment: Provider-patient ratio
timeFrame: On day of caesarean section
measure: Treatment: Delay in diagnosis
timeFrame: On day of caesarean section
measure: Treatment: Delay between diagnosis and caesarean section
timeFrame: On day of caesarean section
measure: Treatment: Access to hospital resources
timeFrame: On day of caesarean section
measure: Training: Level of training
timeFrame: At time of caesarean section
Secondary outcomes:
measure: Cause of death
timeFrame: Maternal death is recorded in-hospital, censored at 30 days.
Other outcomes:
Locations:
city: Observatory
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Professor Bruce M Biccard
role: PRINCIPAL_INVESTIGATOR
References: