免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / The ASOS-2 Trial Maternal Mortality Sub-study
The ASOS-2 Trial Maternal Mortality Sub-study
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Maternal Mortality Cesarean Section Africa | Procedure: Cesarean section |
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:
- Hypertensive disorders in pregnancy
- Obstetric haemorrhage
- Pregnancy-related infection
- Other obstetric complications
- Unanticipated complications of management (iatrogenic)
- Non-obstetric complications (non-obstetric disease, e.g. cardiac disease, malaria)
- Unknown / Undetermined
- Coincidental external causes (e.g. interpersonal violence)
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | May 6, 2019 |
| Estimated Primary Completion Date : | July 31, 2020 |
| Estimated Study Completion Date : | July 31, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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: Cesarean section
Abdominal, operative delivery of the fetus
|
Outcome Measures
Primary Outcome Measures :
- Transport: Mode of transport [ Time Frame: On the day of hospital admission ]Nominal: walking, private transport, ambulance, public transport
- Transport: Distance [ Time Frame: On the day of hospital admission ]Continuous: distance in kilometers from patient's home to hospital
- Transport: Time [ Time Frame: On the day of hospital admission ]Continuous: time in hours from patient's home to hospital
- Transport: Delay in seeking healthcare [ Time Frame: On the day of hospital admission ]Binary: Obstetrician opinion whether there was a clinically important delay in seeking care
- Transport: Delay in transport to healthcare [ Time Frame: On the day of hospital admission ]Binary: Obstetrician opinion whether there was a clinically important delay in transport
- Transport: Inter-facility delay [ Time Frame: At time of death (death recorded in-hospital, censored at 30 days) ]Binary: Did the patient die while waiting for inter-facility transfer?
- Treatment: Referral to high level of care [ Time Frame: In-hospital censored at 30 days ]Binary: Whether or not referral to higher level of care took place
- Treatment: Prophylactic uterotonic use [ Time Frame: On day of caesarean section, at time of caesarean section ]Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
- Treatment: Therapeutic uterotonic use [ Time Frame: On day of caesarean section, at time of caesarean section ]Nominal: Oxytocin, Ergometrine, Misoprostil, Carbetocin, None
- Treatment: Surgical safety checklist [ Time Frame: On day of caesarean section, at time of caesarean section ]Binary: Whether or not a surgical safety checklist was used
- Treatment: Type of anaesthetic [ Time Frame: On day of caesarean section, at time of caesarean section ]Nominal: Regional, general with endotracheal intubation, general without endotracheal intubation.
- Treatment: Airway aspiration [ Time Frame: On day of caesarean section, at time of caesarean section ]Binary: Whether or not airway aspiration occurred
- Treatment: Desaturation [ Time Frame: On day of caesarean section, at time of caesarean section ]Binary: Whether or not desaturation below 90% occurred during management of the airway
- Treatment: Spinal hypotension [ Time Frame: On day of caesarean section, at time of caesarean section ]Binary: Whether or not spinal hypotension occured; systolic BP <= 90mmHg
- Treatment: Interventions to arrest bleeding [ Time Frame: In hospital, censored at 30 days ]Nominal: Which techniques were used? over-sowing, uterine compression suture, uterine artery ligation, uterine tourniquet, intrauterine balloon, hysterectomy, uterine artery embolisation
- Treatment: Blood products [ Time Frame: In hospital, censored at 30 days ]Nominal: Which products were given? Red blood cells, fresh frozen plasma, freeze dried plasma, cryoprecipitate, platelets, whole blood.
- Treatment: Availability of medications [ Time Frame: On day of caesarean section ]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
- Treatment: Availability of blood products [ Time Frame: On day of caesarean section ]Nominal: Red blood cells, Plasma, Platelets, Cryoprecipitate
- Treatment: Availability of resuscitation equipment [ Time Frame: On day of caesarean section ]Nominal: Airway suction, endotracheal intubation equipment, mechanical ventilator, supraglottic airway devices, defibrillator,
- Treatment: Availability of monitoring equipment [ Time Frame: On day of caesarean section ]Nominal: Which monitoring equipment are available in the recovery area and the postoperative ward? O2 saturation, blood pressure, heart rate monitor, thermometer
- Treatment: Recovery area [ Time Frame: On day of caesarean section ]Binary: Is there a dedicated area where the patient is monitored during recovery from anaesthesia for caesarean section?
- Treatment: Provider-patient ratio [ Time Frame: On day of caesarean section ]Interval: Nurse-to-patient ratio in postoperative ward (during the day, during the night)
- Treatment: Delay in diagnosis [ Time Frame: On day of caesarean section ]Binary: Obstetrician opinion whether a clinical important delay in diagnosis occurred
- Treatment: Delay between diagnosis and caesarean section [ Time Frame: On day of caesarean section ]Binary: Obstetrician opinion whether a clinical important delay between diagnosis and caesarean section occurred
- Treatment: Access to hospital resources [ Time Frame: On day of caesarean section ]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.
- Training: Level of training [ Time Frame: At time of caesarean section ]Nominal: Provider level of training at caesarean seciton (for anaesthesia and surgery): Specialist, specialist trainee, non-specialist doctor, non-doctor
Secondary Outcome Measures :
- Cause of death [ Time Frame: Maternal death is recorded in-hospital, censored at 30 days. ]WHO ICD-10 maternal mortality reporting standard
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
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)
Contacts and Locations
Locations
| South Africa | |
| Groote Schuur Hospital | |
| Observatory, Western Cape, South Africa, 7925 | |
Sponsors and Collaborators
University of Cape Town
Bill and Melinda Gates Foundation
Investigators
| Principal Investigator: | Professor Bruce M Biccard | University of Cape Town |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 25, 2019 | ||||
| First Posted Date | July 23, 2019 | ||||
| Last Update Posted Date | January 29, 2020 | ||||
| Actual Study Start Date | May 6, 2019 | ||||
| Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Cause of death [ Time Frame: Maternal death is recorded in-hospital, censored at 30 days. ] WHO ICD-10 maternal mortality reporting standard
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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.
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:
|
||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| Intervention | Procedure: Cesarean section
Abdominal, operative delivery of the fetus
|
||||
| Study Groups/Cohorts | 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.
Intervention: Procedure: Cesarean section
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Enrolling by invitation | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 31, 2020 | ||||
| Estimated Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | South Africa | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04029207 | ||||
| Other Study ID Numbers | ASOS-2 Maternal Mortality | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Bruce Biccard, University of Cape Town | ||||
| Study Sponsor | University of Cape Town | ||||
| Collaborators | Bill and Melinda Gates Foundation | ||||
| Investigators |
|
||||
| PRS Account | University of Cape Town | ||||
| Verification Date | January 2020 | ||||
