Optimising maternal and perinatal outcomes through safe and appropriate caesarean sections (C-Safe) in low- and middle-income countries: a hybrid effectiveness-implementation design stepped-wedge cluster randomised trial with mixed-methods evaluation

niversity of Birmingham0 sites10,000 target enrollmentFebruary 5, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 5, 2024

End Date

August 31, 2027

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

•The inclusion and exclusion criteria will be the same for the field testing phase and the cluster trial phase with the only exception being the site used in the trial phase not being eligible for inclusion in the cluster trial.
•Health facilities are eligible for inclusion if:
•1\. Urban or peri\-urban public facility
•2\. Secondary or tertiary\-level
•3\. Providing comprehensive emergency obstetric care over 12 months
•4\. Around 4,000 births/year
•Participants:
•Healthcare professionals:
•All healthcare professionals working in maternity setting and delivering the interventional package will be included as participants. This includes but is not limited to midwives, nurses, nurse\-midwives, anaesthetists, neonatologists, obstetricians, junior doctors/ medical officers/residents/trainees and clinical officers. Healthcare administrators and managers in charge of the maternity wards or health facilities will be included as participants. This may include but are not limited to the head of obstetrics, matron\-in\-charge, or medical/clinical director.
•All women and pregnant people attending facilities for birth and receiving the interventional package will be included if they are giving birth during the time their site is randomized to the C\-Safe interventional package.

•1\. Sites used in the field\-testing phase will not be eligible to participate in the stepped\-wedged randomized trial
•2\. Sites are not providing Comprehensive Emergency Obstetric and Newborn Care
•3\. Sitesthat were or are part of another intervention trial, or if any components of the C\-Safe interventional package were previously tested on them
•4\. Co\-enrolment with sites with existing related studies will be discouraged