A study to improve the outcomes of mothers and babies through safe and appropriate caesarean sections

Not Applicable

• Conditions: abour and birth including caesarean section and assisted vaginal birth; Pregnancy and Childbirth

• Registration Number: ISRCTN47224807
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-05
• Last Update Posted: 19 February 2024
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 10000

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified