The ASOS-2 Trial Maternal Mortality Sub-study

NCT ID: NCT04029207

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2020-07-31

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)

Conditions

Maternal Mortality; Cesarean Section; Africa

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

African Surgical OutcomeS-2 Trial

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.

Cesarean section

Intervention Type: PROCEDURE

Abdominal, operative delivery of the fetus

Interventions

Cesarean section

Abdominal, operative delivery of the fetus

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Bruce Biccard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor Bruce M Biccard

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Locations

Groote Schuur Hospital

Observatory, Western Cape, South Africa

Countries

South Africa

Other Identifiers

ASOS-2 Maternal Mortality

Identifier Type: -

Identifier Source: org_study_id