The ASOS-2 Trial Maternal Mortality Sub-study
Maneno muhimu
Kikemikali
Maelezo
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)
Tarehe
Imethibitishwa Mwisho: | 12/31/2019 |
Iliyowasilishwa Kwanza: | 06/24/2019 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 07/21/2019 |
Iliyotumwa Kwanza: | 07/22/2019 |
Sasisho la Mwisho Liliwasilishwa: | 01/26/2020 |
Sasisho la Mwisho Lilichapishwa: | 01/28/2020 |
Tarehe halisi ya kuanza kwa masomo: | 05/05/2019 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 07/30/2020 |
Tarehe ya Kukamilisha Utafiti: | 07/30/2020 |
Hali au ugonjwa
Uingiliaji / matibabu
Procedure: African Surgical OutcomeS-2 Trial
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
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. | Procedure: African Surgical OutcomeS-2 Trial Abdominal, operative delivery of the fetus |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | Female |
Njia ya sampuli | Non-Probability Sample |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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) |
Matokeo
Hatua za Matokeo ya Msingi
1. Transport: Mode of transport [On the day of hospital admission]
2. Transport: Distance [On the day of hospital admission]
3. Transport: Time [On the day of hospital admission]
4. Transport: Delay in seeking healthcare [On the day of hospital admission]
5. Transport: Delay in transport to healthcare [On the day of hospital admission]
6. Transport: Inter-facility delay [At time of death (death recorded in-hospital, censored at 30 days)]
7. Treatment: Referral to high level of care [In-hospital censored at 30 days]
8. Treatment: Prophylactic uterotonic use [On day of caesarean section, at time of caesarean section]
9. Treatment: Therapeutic uterotonic use [On day of caesarean section, at time of caesarean section]
10. Treatment: Surgical safety checklist [On day of caesarean section, at time of caesarean section]
11. Treatment: Type of anaesthetic [On day of caesarean section, at time of caesarean section]
12. Treatment: Airway aspiration [On day of caesarean section, at time of caesarean section]
13. Treatment: Desaturation [On day of caesarean section, at time of caesarean section]
14. Treatment: Spinal hypotension [On day of caesarean section, at time of caesarean section]
15. Treatment: Interventions to arrest bleeding [In hospital, censored at 30 days]
16. Treatment: Blood products [In hospital, censored at 30 days]
17. Treatment: Availability of medications [On day of caesarean section]
18. Treatment: Availability of blood products [On day of caesarean section]
19. Treatment: Availability of resuscitation equipment [On day of caesarean section]
20. Treatment: Availability of monitoring equipment [On day of caesarean section]
21. Treatment: Recovery area [On day of caesarean section]
22. Treatment: Provider-patient ratio [On day of caesarean section]
23. Treatment: Delay in diagnosis [On day of caesarean section]
24. Treatment: Delay between diagnosis and caesarean section [On day of caesarean section]
25. Treatment: Access to hospital resources [On day of caesarean section]
26. Training: Level of training [At time of caesarean section]
Hatua za Matokeo ya Sekondari
1. Cause of death [Maternal death is recorded in-hospital, censored at 30 days.]