xC-Safe: Optimising maternal and perinatal outcomes through safe and appropriate caesarean sections in low- and middle-income countries (LMIC)
Lead Research Organisation:
University of Birmingham
Department Name: Inst of Metabolism & Systems Research
Abstract
WHAT IS THE PROBLEM?
Caesarean section is considered a life-saving procedure for pregnant women and their babies. Yet, in low- and middle-income countries, mothers who give birth by caesarean section are 100 times more likely to die than those having the procedure in high-income countries. In these settings, caesarean sections also contribute to life-long health problems that affect the women's quality of life and their ability to safely have more children. Their babies are also at high risk of dying during or soon after caesarean section.
The three main reasons for poor outcomes after caesarean section in low- and middle-income countries are:
1. Inappropriate caesarean sections (e.g. performed 'too many, too soon' or 'too little, too late')
2. Unsafe practices in performing the procedure
3. Substandard care in labour (e.g. not culminating in vaginal birth which leads to complicated caesarean sections in advanced labour).
Many issues contribute to the above problems such as lack of knowledge and skills to undertake safe caesarean section (and to achieve safe vaginal births - both normal and by using instruments). In addition, attitudes towards caesarean section and use of vacuum or forceps, marginalisation of midwives, dysfunctional teamwork, a culture of blame and medico-legal concerns, influence of family members and communities in decision-making, poor communication skills between women and healthcare providers and amongst clinicians, and inability to determine why caesarean sections are performed worsen the problem.
WHAT IS NEEDED?
There is no single solution to the above complex problems. We need to both improve the safety of caesarean sections and ensure they are only done when needed. To do this, we will co-develop evidence-based interventions that are acceptable, equitable, sustainable and which can be adapted or scaled-up cost-effectively across settings, by collaborating with women and their support networks, healthcare providers, policymakers and other relevant stakeholders.
WHAT IS OUR AIM?
We propose a 5-year Programme that aims to improve mother and baby outcomes following caesarean sections in low- and middle-income countries. The Programme (C-Safe) plans to (ii) ensure caesarean sections are done for the right reasons (C-Why), (ii) improve their safety (C-Op), and (iii) promote safe and respectful care in labour resulting in vaginal births, including safe delivery with instruments (C-Non). The C-Safe intervention will be implemented using a comprehensive training Programme, empowerment of local opinion leaders (C-Safe Champions) and mothers, team-based working, and learning through audit and feedback, in four hospitals each in India and Tanzania (30,000 births).
WHAT WILL WE DO?
The C-Safe Programme involves four work packages that will (i) identify and bring together evidence on the effects of interventions and outcomes, (ii) rank the interventions and outcomes according to their importance to key local professionals, local maternity care users, and community members, (iii) develop the interventions with regional healthcare providers, women and policymakers on what is considered to be beneficial, acceptable, relevant, accessible and feasible and (iv) test whether the C-Safe strategy changes practices and increases uptake of the intervention by healthcare providers, as well as the number of women receiving it. We will also assess costs and views of healthcare providers, women, their family and community members on being part of it. Building academic and training capacity and capability, and involving women and their communities in all aspects of the study, are core features.
WHO ARE THE TEAM MEMBERS?
The team includes doctors, , midwives, experts in study design, patient and public involvement groups, trainers, policymakers. They are supported by members of the World Health Organization, UNICEF, Jhpiego, Professional associations, ELLY Charity.
Caesarean section is considered a life-saving procedure for pregnant women and their babies. Yet, in low- and middle-income countries, mothers who give birth by caesarean section are 100 times more likely to die than those having the procedure in high-income countries. In these settings, caesarean sections also contribute to life-long health problems that affect the women's quality of life and their ability to safely have more children. Their babies are also at high risk of dying during or soon after caesarean section.
The three main reasons for poor outcomes after caesarean section in low- and middle-income countries are:
1. Inappropriate caesarean sections (e.g. performed 'too many, too soon' or 'too little, too late')
2. Unsafe practices in performing the procedure
3. Substandard care in labour (e.g. not culminating in vaginal birth which leads to complicated caesarean sections in advanced labour).
Many issues contribute to the above problems such as lack of knowledge and skills to undertake safe caesarean section (and to achieve safe vaginal births - both normal and by using instruments). In addition, attitudes towards caesarean section and use of vacuum or forceps, marginalisation of midwives, dysfunctional teamwork, a culture of blame and medico-legal concerns, influence of family members and communities in decision-making, poor communication skills between women and healthcare providers and amongst clinicians, and inability to determine why caesarean sections are performed worsen the problem.
WHAT IS NEEDED?
There is no single solution to the above complex problems. We need to both improve the safety of caesarean sections and ensure they are only done when needed. To do this, we will co-develop evidence-based interventions that are acceptable, equitable, sustainable and which can be adapted or scaled-up cost-effectively across settings, by collaborating with women and their support networks, healthcare providers, policymakers and other relevant stakeholders.
WHAT IS OUR AIM?
We propose a 5-year Programme that aims to improve mother and baby outcomes following caesarean sections in low- and middle-income countries. The Programme (C-Safe) plans to (ii) ensure caesarean sections are done for the right reasons (C-Why), (ii) improve their safety (C-Op), and (iii) promote safe and respectful care in labour resulting in vaginal births, including safe delivery with instruments (C-Non). The C-Safe intervention will be implemented using a comprehensive training Programme, empowerment of local opinion leaders (C-Safe Champions) and mothers, team-based working, and learning through audit and feedback, in four hospitals each in India and Tanzania (30,000 births).
WHAT WILL WE DO?
The C-Safe Programme involves four work packages that will (i) identify and bring together evidence on the effects of interventions and outcomes, (ii) rank the interventions and outcomes according to their importance to key local professionals, local maternity care users, and community members, (iii) develop the interventions with regional healthcare providers, women and policymakers on what is considered to be beneficial, acceptable, relevant, accessible and feasible and (iv) test whether the C-Safe strategy changes practices and increases uptake of the intervention by healthcare providers, as well as the number of women receiving it. We will also assess costs and views of healthcare providers, women, their family and community members on being part of it. Building academic and training capacity and capability, and involving women and their communities in all aspects of the study, are core features.
WHO ARE THE TEAM MEMBERS?
The team includes doctors, , midwives, experts in study design, patient and public involvement groups, trainers, policymakers. They are supported by members of the World Health Organization, UNICEF, Jhpiego, Professional associations, ELLY Charity.
Technical Summary
THE PROBLEM
Maternal and perinatal mortality following caesarean section (CS) is disproportionately high in low- and middle-income countries (LMICs) than in high-income countries (HIC). Unnecessary CSs and unsafe practices arising from limited intra-operative expertise and gaps in knowledge and skills to achieve safe vaginal births, particularly assisted vaginal delivery (AVD), contribute to adverse maternal and perinatal outcomes.
EVIDENCE GAPS
Studies have reported the effects of individual interventions to prevent specific intra-operative CS complications - but none have evaluated the interventions as a comprehensive package to avoid both maternal and perinatal complications following CS in LMICs. While there is a robust system to report 'in whom' CSs are performed, there is no equivalent system to report 'why' they are performed, with poor and varied reporting of CS indications. While the use of vacuum and forceps can avoid difficult and complex CSs, they are rarely used in LMICs - effective interventions are needed to increase AVD use along with physiological births. Unless all the above challenges are addressed in LMICs, we cannot achieve reductions in maternal and perinatal deaths following CS.
AIM
To achieve safe and appropriate CS, and where possible avoid CS, through comprehensive, effective, acceptable, implementable, scalable and sustainable intervention(s) in LMIC settings.
OUR PLAN
A Programme (C-Safe) with interlinked work packages co-developed with women and local teams on CS appropriateness (C-Why), CS safety (C-Op), and safe vaginal births including AVD (C-Non), underpinned by robust implementation strategy (training Programme, C-Safe Champions, team-based work, audit and feedback), to improve pregnancy outcomes. We will undertake systematic reviews, Delphi surveys, stepped-wedge cluster randomised trial (8 sites in India and Tanzania; 30,000 births) with mixed-method evaluation and meaningful stakeholder engagement.
Maternal and perinatal mortality following caesarean section (CS) is disproportionately high in low- and middle-income countries (LMICs) than in high-income countries (HIC). Unnecessary CSs and unsafe practices arising from limited intra-operative expertise and gaps in knowledge and skills to achieve safe vaginal births, particularly assisted vaginal delivery (AVD), contribute to adverse maternal and perinatal outcomes.
EVIDENCE GAPS
Studies have reported the effects of individual interventions to prevent specific intra-operative CS complications - but none have evaluated the interventions as a comprehensive package to avoid both maternal and perinatal complications following CS in LMICs. While there is a robust system to report 'in whom' CSs are performed, there is no equivalent system to report 'why' they are performed, with poor and varied reporting of CS indications. While the use of vacuum and forceps can avoid difficult and complex CSs, they are rarely used in LMICs - effective interventions are needed to increase AVD use along with physiological births. Unless all the above challenges are addressed in LMICs, we cannot achieve reductions in maternal and perinatal deaths following CS.
AIM
To achieve safe and appropriate CS, and where possible avoid CS, through comprehensive, effective, acceptable, implementable, scalable and sustainable intervention(s) in LMIC settings.
OUR PLAN
A Programme (C-Safe) with interlinked work packages co-developed with women and local teams on CS appropriateness (C-Why), CS safety (C-Op), and safe vaginal births including AVD (C-Non), underpinned by robust implementation strategy (training Programme, C-Safe Champions, team-based work, audit and feedback), to improve pregnancy outcomes. We will undertake systematic reviews, Delphi surveys, stepped-wedge cluster randomised trial (8 sites in India and Tanzania; 30,000 births) with mixed-method evaluation and meaningful stakeholder engagement.
