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
Labour and birth including caesarean section and assisted vaginal birth
After a 2-month baseline period, clusters (public hospitals) will be randomised to the order in which they will receive the C-Safe interventional package for the remainder of the 12-month period, allowing 2 months for full implementation and embedding of the interventional package. The health facilities not receiving the interventional package will continue to follow usual care as per the baseline period until they receive the interventional package. Randomisation will be conducted by an independent statistician, with the order concealed from study investigators until one month before the start of the transition date. Clusters will be randomised to one of four sequences which will dictate the order of the roll-out of the intervention to clusters, stratified by country. The health facilities will be sufficiently geographically distanced to avoid issues around intervention contamination (e.g. staff moving from an intervention site to a control site and taking the intervention techniques with them). Follow–up will be for one month after month 12 of the intervention phase. The C-Safe intervention will include the following packages and training around the delivery of these. Audit and feedback will form part of the intervention. The components may include but are not limited to: 1. C-Why package (decision-making tools for appropriate caesarean section, audit and feedback of caesarean section indications based on the co-developed C-Why classification system). 2. C-Op package (surgical safety interventions including the WHO surgical safety checklist, team huddle and C-Op checklist, vaginal cleansing, single dose prophylactic antibiotics, incision type, surgical drapes and colour-coded suction bottles to detect post-partum haemorrhage, uterotonics, changing gloves and instruments before wound closure, delayed cord clamping and resuscitation for the baby, clinical care handover report). 3. C-Non package (promoting vaginal birth through components of the WHO labour care g
Current participant inclusion criteria as of 24/06/2025: The inclusion and exclusion criteria will be the same for the field testing phase and the cluster trial phase, with the only exception being that the site used in the trial phase will not be eligible for inclusion in the cluster trial. Cluster: 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. A minimum of 2,000 births/year Participants: Healthcare professionals: All healthcare professionals working in a 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 is not limited to, the head of obstetrics, matron-in-charge, or medical/clinical director. Women: 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. Previous participant inclusion criteria: 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. Cluster: 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 pac
1. Sites used in the field-testing phase will not be eligible to participate in the stepped-wedge randomized trial 2. Sites are not providing Comprehensive Emergency Obstetric and Newborn Care 3. Sites that 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