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The ASOS-2 Trial Maternal Mortality Sub-study

NCT04029207 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-01-29

No results posted yet for this study

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.

Conditions

  • Maternal Mortality
  • Cesarean Section
  • Africa

Interventions

PROCEDURE

Cesarean section

Abdominal, operative delivery of the fetus

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Professor Bruce M Biccard · University of Cape Town

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029207 on ClinicalTrials.gov