C-Safe: Optimizing maternal and perinatal outcomes through safe and appropriate caesarean sections in low-and middle-income countries (LMIC)EC.Ref No. 47_2023
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 4,000
- 试验地点
- 5
- 主要终点
- Our main outcomes include the following:Caesarean section rate per month, Assisted vaginal birth rate per month, Vaginal birth rate (not including assisted vaginal births) per month, Rates of mode of birth in Robsons groups (1-4) per month, Indications for caesarean sections per month, Use of C-Safe checklists and delivery of the C-Safe packages (C-Op and C-Non) per month
研究概览
简要总结
C-Safe aims to develop, implement, and evaluate a multi-faceted intervention (C-Safe) targeting healthcare professionals, pregnant women, families, communities and health systems to reduce maternal and perinatal mortality and morbidity following caesarean section (CS) in Iow- and middle-income countries (LMIC).
It is a programme with four work packages.
- package 1 and 2 map the evidence and prioritize components of the intervention and outcome measures.
- package 3 will co-develop and refine the intervention in a field testing phase
- package 4 will test the intervention (stepped wedge cluster randomised controlled trial with surveys and qualitative research).
This registration and these methods relate specifically to packages 3 and 4.
Given the complex challenges that affect trial design and successful implementation in the C-Safe intervention, a field-testing phase will be conducted ahead of the cluster trial. The field-testing phase will use mixed-methods to understand how birth is currently managed in the study settings, as a basis for tailoring and adapting the implementation of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects include healthcare professionals and managers in maternity wards of the selected facilities, as well as women who have given birth in the previous month.
- •Cluster: Health facilities are eligible for inclusion if:
- •Urban or peri-urban public facility
- •Secondary or tertiary-level
- •Providing comprehensive emergency obstetric care (50) over 12 months (see Box 1)
- •Minimum of 4,000 births/ year.
排除标准
- •Sites used in the field-testing phase will not be eligible to participate in the stepped wedged randomized trial.
- •We will exclude sites if they are not providing Comprehensive Emergency Obstetric and Newborn Care.
- •We will also exclude sites if they were or are, part of another intervention trial, or if any components of the C-Safe interventional package were previously tested on them.
- •Co-enrolment with sites with existing related studies will be discouraged.
结局指标
主要结局
Our main outcomes include the following:Caesarean section rate per month, Assisted vaginal birth rate per month, Vaginal birth rate (not including assisted vaginal births) per month, Rates of mode of birth in Robsons groups (1-4) per month, Indications for caesarean sections per month, Use of C-Safe checklists and delivery of the C-Safe packages (C-Op and C-Non) per month
时间窗: 3, 6 ,9 months
次要结局
- secondary outcomes are those on implementation, acceptability, equity and clinical outcomes(implementation- 3 months, Acceptability - baseline, 3,6 and 12 months,)
研究者
Ms Inderjeet Kaur
Fernandez Foundation