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

Status Enrolling by invitation

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.

Clinical 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) ;

Related Conditions & MeSH terms

• Africa
• Cesarean Section
• Maternal Death
• Maternal Mortality

• NCT number: NCT04029207
• Study type: Observational
• Source: University of Cape Town
• Status: Enrolling by invitation
• Start date: May 6, 2019
• Completion date: July 31, 2020