Labour and birth including caesarean section and assisted vaginal birth Pregnancy and Childbirth
Conditions
Interventions
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, allo
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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 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. 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 24/06/2025: The main outcomes are those measuring the change in practice and are likely to lead to improvements in clinical practice. Co-Primary outcomes are: 1. Caesarean section rate measured as the number of caesarean section births out of the number of total births in Robson groups (1-4), which are defined as: Group 1: Number of nulliparous women, with a singleton fetus with a cephalic presentation at term gestation (=37+0 weeks) in spontaneous labour Group 2: Nulliparous, singleton, cephalic, term births with induced labour or prelabour caesarean section Group 3: Multiparous, singleton, cephalic, term births without previous caesarean section in spontaneous labour Group 4: Multiparous, singleton, cephalic, term births without previous caesarean section with induced labour or prelabour caesarean section 2. Adherence to safe perioperative measures during caesarean section which is defined as adherence to 4 out of 5 C-Op components (prospective us of the WHO CS modified Surgical Safety checklist, administration of prophylactic antibiotics 30-60 minutes before skin incision, vaginal cleansing before procedure, administration of prophylactic uterotonics immediately after birth of baby, and changing of gloves and instruments prior to sheath closure). Previous primary outcome measures: The main outcomes are those measuring the change in practice, and likely to lead to improvements in clinical practice. Changes in more than one process outcome will be required to improve maternal and perinatal clinical outcomes, therefore the main outcomes include the following: 1. Caesarean section rate measured as the number of caesarean section births out of the number of total births taking place per month 2. Assisted vaginal birth rate measured as the number of assisted vaginal births out of the number of total births taking place per month 3. Spontaneous vaginal birth rate (not including assisted vaginal births) measured as the number of ( | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/06/2025: Implementation, acceptability, equity and maternal and perinatal mortality and morbidity (clinical outcomes). Implementation outcomes include the following: 1. Reach (measured as the proportion of women who receive the C-Safe intervention at 3 months after implementation) 2. Adoption (measured as the proportion of healthcare professionals trained at 3 months after implementation) 3. Fidelity (measured as the proportion of individual intervention components given as specified at 3 months after implementation) 4. Adaption (measured as the number of intervention components modified at 3 months after implementation) 5. Appropriateness (measured as perceived fit of the intervention at 3 months after implementation) Acceptability and equity outcomes include the following: 1. Acceptability to women and healthcare providers measured using interviews, surveys and observations at baseline, end of month 6 and month 12 2. Barriers to intervention delivery or study conduct measured using interviews, surveys and observations at baseline, end of month 6 and month 12 3. Patient-reported outcomes such as dignity, information sharing, and positive birth experience, measured using interviews, surveys and observations at baseline, end of month 6 and month 12 Clinical outcomes include the following and will be collected monthly throughout the trial period: Maternal: 1. Postpartum haemorrhage (defined as blood loss =500 ml after birth) measured for all births 2. Surgical site infection (defined as an infection that occurs within 30 days after the operation and involves the skin and subcutaneous tissue of the incision (superficial incisional) and/or the deep soft tissue (for example, fascia, muscle) of the incision (deep incisional) and/or any part of the anatomy (for example, organs and spaces) other than the incision that was opened or manipulated during an operation (organ/space), measured until discharge from hospital. 3. Number | — |
Countries
India, Tanzania
Outcome results
None listed