Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol.

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.Trial registration: ISRCTN67214403.

A research agenda to improve incidence and outcomes of assisted vaginal birth.

Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.

L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en œuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en œuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.

El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.

Educational interventions targeting pregnant women to optimise the use of caesarean section: What are the essential elements? A qualitative comparative analysis.

BACKGROUND: Caesarean section (CS) rates are increasing globally, posing risks to women and babies. To reduce CS, educational interventions targeting pregnant women have been implemented globally, however, their effectiveness is varied. To optimise benefits of these interventions, it is important to understand which intervention components influence success. In this study, we aimed to identify essential intervention components that lead to successful implementation of interventions focusing on pregnant women to optimise CS use. METHODS: We re-analysed existing systematic reviews that were used to develop and update WHO guidelines on non-clinical interventions to optimise CS. To identify if certain combinations of intervention components (e.g., how the intervention was delivered, and contextual characteristics) are associated with successful implementation, we conducted a Qualitative Comparative Analysis (QCA). We defined successful interventions as interventions that were able to reduce CS rates. We included 36 papers, comprising 17 CS intervention studies and an additional 19 sibling studies (e.g., secondary analyses, process evaluations) reporting on these interventions to identify intervention components. We conducted QCA in six stages: 1) Identifying conditions and calibrating the data; 2) Constructing truth tables, 3) Checking quality of truth tables; 4) Identifying parsimonious configurations through Boolean minimization; 5) Checking quality of the solution; 6) Interpretation of solutions. We used existing published qualitative evidence synthesis to develop potential theories driving intervention success. RESULTS: We found successful interventions were those that leveraged social or peer support through group-based intervention delivery, provided communication materials to women, encouraged emotional support by partner or family participation, and gave women opportunities to interact with health providers. Unsuccessful interventions were characterised by the absence of at least two of these components. CONCLUSION: We identified four key essential intervention components which can lead to successful interventions targeting women to reduce CS. These four components are 1) group-based delivery, 2) provision of IEC materials, 3) partner or family member involvement, and 4) opportunity for women to interact with health providers. Maternal health services and hospitals aiming to better prepare women for vaginal birth and reduce CS can consider including the identified components to optimise health and well-being benefits for the woman and baby.

Interventions to reintroduce or increase assisted vaginal births: a systematic review of the literature.

OBJECTIVE: To synthesise the evidence from studies that implemented interventions to increase/reintroduce the use of assisted vaginal births (AVB). DESIGN: Systematic review. ELIGIBILITY CRITERIA: We included experimental, semi-experimental and observational studies that reported any intervention to reintroduce/increase AVB use. DATA SOURCES: We searched PubMed, EMBASE, CINAHL, LILACS, Scopus, Cochrane, WHO Library, Web of Science, ClinicalTrials.gov and WHO.int/ictrp through September 2021. RISK OF BIAS: For trials, we used the Cochrane Effective Practice and Organisation of Care tool; for other designs we used Risk of Bias for Non-Randomised Studies of Interventions. DATA EXTRACTION AND SYNTHESIS: Due to heterogeneity in interventions, we did not conduct meta-analyses. We present data descriptively, grouping studies according to settings: high-income countries (HICs) or low/middle-income countries (LMICs). We classified direction of intervention effects as (a) statistically significant increase or decrease, (b) no statistically significant change or (c) statistical significance not reported in primary study. We provide qualitative syntheses of the main barriers and enablers for success of the intervention. RESULTS: We included 16 studies (10 from LMICs), mostly of low or moderate methodological quality, which described interventions with various components (eg, didactic sessions, simulation, hands-on training, guidelines, audit/feedback). All HICs studies described isolated initiatives to increase AVB use; 9/10 LMIC studies tested initiatives to increase AVB use as part of larger multicomponent interventions to improve maternal/perinatal healthcare. No study assessed women's views or designed interventions using behavioural theories. Overall, interventions were less successful in LMICs than in HICs. Increase in AVB use was not associated with significant increase in adverse maternal or perinatal outcomes. The main barriers to the successful implementation of the initiatives were related to staff and hospital environment. CONCLUSIONS: There is insufficient evidence to indicate which intervention, or combination of interventions, is more effective to safely increase AVB use. More research is needed, especially in LMICs, including studies that design interventions taking into account theories of behaviour change. PROSPERO REGISTRATION NUMBER: CRD42020215224.

Interventions targeting healthcare providers to optimise use of caesarean section: a qualitative comparative analysis to identify important intervention features.

BACKGROUND: Rapid increases in caesarean section (CS) rates have been observed globally; however, CS rates exceeding 15% at a population-level have limited benefits for women and babies. Many interventions targeting healthcare providers have been developed to optimise use of CS, typically aiming to improve and monitor clinical decision-making. However, interventions are often complex, and effectiveness is varied. Understanding intervention and implementation features that likely lead to optimised CS use is important to optimise benefits. The aim of this study was to identify important components that lead to successful interventions to optimise CS, focusing on interventions targeting healthcare providers.  METHODS: We used Qualitative Comparative Analysis (QCA) to identify if certain combination of important intervention features (e.g. type of intervention, contextual characteristics, and how the intervention was delivered) are associated with a successful intervention as reflected in a reduction of CS. We included 21 intervention studies targeting healthcare providers to reduce CS, comprising of 34 papers reporting on these interventions. To develop potential theories driving intervention success, we used existing published qualitative evidence syntheses on healthcare providers' perspectives and experiences of interventions targeted at them to reduce CS. RESULTS: We identified five important components that trigger successful interventions targeting healthcare providers: 1) training to improve providers' knowledge and skills, 2) active dissemination of CS indications, 3) actionable recommendations, 4) multidisciplinary collaboration, and 5) providers' willingness to change. Importantly, when one or more of these components are absent, dictated nature of intervention, where providers are enforced to adhere to the intervention, is needed to prompt successful interventions. Unsuccessful interventions were characterised by the absence of these components. CONCLUSION: We identified five important intervention components and combinations of intervention components which can lead to successful interventions targeting healthcare providers to optimise CS use. Health facility managers, researchers, and policy-makers aiming to improve providers' clinical decision making and reduce CS may consider including the identified components to optimise benefits.

Association between prelabour caesarean section and perinatal outcomes: analysis of demographic and health surveys from 26 low-income and middle-income countries.

OBJECTIVES: Caesarean section (CS) conducted before labour (prelabour CS (PLCS)), compared with vaginal birth, may pose additional maternal and perinatal risks. No multicountry analysis has examined PLCS in low-income and middle-income countries (LMICs). This study assessed rates, risk factors and associations of PLCS with perinatal outcomes in LMICs. DESIGN: Population-based cross-sectional surveys. SETTING: Demographic and Health Surveys conducted between 2015 and 2018 in 26 LMICs (13 countries in Africa, 11 in Asia and 2 in the Americas). PARTICIPANTS: Women aged 15-49 years with singleton term births. OUTCOME MEASURES: Main outcomes were early neonatal mortality, neonatal mortality, early breastfeeding (within 1 hour of birth), skin-to-skin contact and duration of hospital stay. RESULTS: 255 227 women were included in the main analysis. Average rates of primary PLCS ranged from 1.3% in Zambia to 19.5% in Maldives. Median PLCS rate was 1.8% in the poorest versus 5.8% in the richest subgroups.Higher maternal age, education, economic status and BMI, lower parity, urban residence, delivery in private hospitals, larger baby size, having health insurance, more antenatal care (ANC) visits, ANC by a doctor and ANC in private hospitals were associated with increased primary PLCS.Across the 26 countries, primary PLCS, compared with vaginal delivery, was associated with increased neonatal mortality (adjusted odds ratio, aOR 1.2, 95% CI 1.0 to 1.5), decreased early breastfeeding (aOR 0.4, 95% CI 0.3 to 0.5) and skin-to-skin contact (aOR 0.4, 95% CI 0.3 to 0.5) and longer hospital stay (aOR 6.6, 95% CI 5.9 to 7.4). No significant association was found for early neonatal mortality (aOR 1.2, 95% CI 0.9 to 1.5). CONCLUSION: Primary PLCS, compared with vaginal birth, is associated with adverse perinatal outcomes in singleton term pregnancies in LMICs. Caesarean births should be audited regularly to monitor trends, appropriateness and context-specific drivers of CS.

Collaborative model of intrapartum care: qualitative study on barriers and facilitators to implementation in a private Brazilian hospital.

INTRODUCTION: A collaborative (midwife-obstetrician) model of intrapartum care (CMIC) is associated with lower caesarean section (CS) rates than physician-led models. In 2019, the largest private maternity hospital in Latin America (14.000 deliveries/year, 89% CS) created a quality improvement initiative to optimise intrapartum care and safely reduce CS in low-risk women managed by its internal team of healthcare providers (HCP). We conducted formative research to identify potential barriers and facilitators to the implementation of a CMIC. METHODS: Three groups of stakeholders participated in focus groups and interviews: hospital managers and clinical coordinators, HCP working in labour/delivery wards and pregnant women intending to give birth in the hospital. We explored participants' views about the acceptability of implementing a CMIC where a nurse-midwife (NM) on shift would be the main intrapartum HCP, with continuous support/supervision of a dedicated, in-house, obstetrician-gynaecologist (OB-GYN). A thematic analysis approach was used. RESULTS: 12 HCPs, 5 clinical coordinators, 2 hospital managers and 7 women participated. OB-GYNs, coordinators and managers highlighted health system, organisational and structural factors (NMs' limited experience/skills, professional roles, financial reimbursement) as potential barriers. NMs identified logistical and human resources as additional barriers. Women viewed the CMIC with perplexity and insecurity because of cultural beliefs about the dominant role of OB-GYNs, and limited information about NM's capabilities. All professionals agreed that women's acceptance of a CMIC will require educational interventions and communication strategies to inform potential users about the advantages and safety of this model. CONCLUSION: There are important barriers and facilitators to implement a CMIC in a private Brazilian maternity hospital. Factors related to health system structure and organisation may have the greatest impact. A CMIC is more likely to succeed if stakeholders' concerns about responsibilities, power and financial revenues are addressed, and educational interventions targeted at users are deployed prior to its implementation.

Do women prefer caesarean sections? A qualitative evidence synthesis of their views and experiences.

BACKGROUND: Caesarean sections (CS) continue to increase worldwide. Multiple and complex factors are contributing to the increase, including non-clinical factors related to individual women, families and their interactions with health providers. This global qualitative evidence synthesis explores women's preferences for mode of birth and factors underlying preferences for CS. METHODS: Systematic database searches (MEDLINE, EMBASE, CINAHL, PsycINFO) were conducted in December 2016 and updated in May 2019 and February 2021. Studies conducted across all resource settings were eligible for inclusion, except those from China and Taiwan which have been reported in a companion publication. Phenomena of interest were opinions, views and perspectives of women regarding preferences for mode of birth, attributes of CS, societal and cultural beliefs about modes of birth, and right to choose mode of birth. Thematic synthesis of data was conducted. Confidence in findings was assessed using GRADE-CERQual. RESULTS: We included 52 studies, from 28 countries, encompassing the views and perspectives of pregnant women, non-pregnant women, women with previous CS, postpartum women, and women's partners. Most of the studies were conducted in high-income countries and published between 2011 and 2021. Factors underlying women preferences for CS had to do mainly with strong fear of pain and injuries to the mother and child during labour or birth (High confidence), uncertainty regarding vaginal birth (High confidence), and positive views or perceived advantages of CS (High confidence). Women who preferred CS expressed resoluteness about it, but there were also many women who had a clear preference for vaginal birth and those who even developed strategies to keep their birth plans in environments that were not supportive of vaginal births (High confidence). The findings also identified that social, cultural and personal factors as well as attributes related to health systems impact on the reasons underlying women preferences for various modes of birth (High confidence). CONCLUSIONS: A wide variety of factors underlie women's preferences for CS in the absence of medical indications. Major factors contributing to perceptions of CS as preferable include fear of pain, uncertainty with vaginal birth and positive views on CS. Interventions need to address these factors to reduce unnecessary CS.

Prevalence of and reasons for women's, family members', and health professionals' preferences for cesarean section in Iran: a mixed-methods systematic review.

BACKGROUND: Cesarean section (CS) rates have been increasing globally. Iran has one of the highest CS rates in the world (47.9%). This review was conducted to assess the prevalence of and reasons for women's, family members', and health professionals' preferences for CS in Iran. METHODS AND FINDINGS: In this mixed-methods systematic review, we searched MEDLINE/PubMed, Embase, CINAHL, POPLINE, PsycINFO, Global Health Library, Google scholar; as well as Iranian scientific databases including SID, and Magiran from 1 January 1990 to 8th October 2019. Primary quantitative, qualitative, and mixed-methods studies that had been conducted in Iran with Persian or English languages were included. Meta-analysis of quantitative studies was conducted by extracting data from 65 cross-sectional, longitudinal, and baseline measurements of interventional studies. For meta-synthesis, we used 26 qualitative studies with designs such as ethnography, phenomenology, case studies, and grounded theory. The Review Manager Version 5.3 and the Comprehensive Meta-Analysis (CMA) software were used for meta-analysis and meta-regression analysis. Results showed that 5.46% of nulliparous women (95% CI 5.38-5.50%; χ2 = 1117.39; df = 28 [p < 0.00001]; I2 = 97%) preferred a CS mode of delivery. Results of subgroup analysis based on the time of pregnancy showed that proportions of preference for CS reported by women were 5.94% (95% CI 5.86-5.99%) in early and middle pregnancy, and 3.81% (95% CI 3.74-3.83%), in late pregnancy. The heterogeneity was high in this review. Most women were pregnant, regardless of their parity; the risk level of participants were unknown, and some Persian publications were appraised as low in quality. A combined inductive and deductive approach was used to synthesis the qualitative data, and CERQual was used to assess confidence in the findings. Meta-synthesis generated 10 emerging themes and three final themes: 'Women's factors', 'Health professional factors', andex 'Health organization, facility, or system factors'. CONCLUSION: Despite low preference for CS among women, CS rates are still so high. This implies the role of factors beyond the individual will. We identified a multiple individual, health facility, and health system factors which affected the preference for CS in Iran. Numerous attempts were made in recent years to design, test and implement interventions to decrease unnecessary CS in Iran, such as mother-friendly hospitals, standard protocols for labor and birth, preparation classes for women, midwives, and gynaecologists, and workshops for specialists and midwives through the "health sector evolution policy". Although these programs were effective, high rates of CS persist and more efforts are needed to optimize the use of CS.

Reducing unnecessary caesarean sections: scoping review of financial and regulatory interventions.

BACKGROUND: Caesarean sections (CS) are increasing worldwide. Financial incentives and related regulatory and legislative factors are important determinants of CS rates. This scoping review examines the evidence base of financial, regulatory and legislative interventions intended to reduce CS rates. METHODS: We searched MEDLINE, EMBASE, CINAHL and two trials registers in June 2019. Both experimental and observational intervention studies were eligible for inclusion. Primary outcome measures were: CS, spontaneous vaginal and instrumental birth rates. We assessed quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. RESULTS: We identified 9057 articles and assessed 65 full-texts. We included 16 observational studies. Most of the studies were conducted in high-income countries. Three studies assessed payment methods for health workers: equalising physician fees for vaginal and caesarean delivery reduced CS rates in one study; however, little or no difference in CS rates was found in the remaining two studies. Nine studies assessed payment methods for health organisations: There was no difference in CS rates between diagnosis-related group (DRG) payment system compared to fee-for-service system in one study. However, DRG system was associated with lower odds for CS in another study. There was little or no difference in CS rates following implementation of global budget payment (GBP) system in two studies. Vaginal birth after caesarean section (VBAC) increased after implementation of a case-based payment system in one study. Caesarean section increased while VBAC rates decreased following implementation of a cap-based payment system in another study. Financial incentive for providers to promote vaginal delivery combined with free vaginal delivery policy was found to reduce CS rates in one study. Studied regulatory and legislative interventions (comprising legislatively imposed practice guidelines for physicians in one study and multi-faceted strategy which included policies to control CS on maternal request in another study) were found to reduce CS rates. The GRADE quality of evidence varied from very low to low. CONCLUSIONS: Available evidence on the effects of financial and regulatory strategies intended to reduce unnecessary CS is inconclusive given inconsistency in effects and low quality of the available evidence. More rigorous studies are needed.

Implementation and evaluation of nonclinical interventions for appropriate use of cesarean section in low- and middle-income countries: protocol for a multisite hybrid effectiveness-implementation type III trial.

BACKGROUND: While cesarean sections (CSs) are a life-saving intervention, an increasing number are performed without medical reasons in low- and middle-income countries (LMICs). Unnecessary CS diverts scarce resources and thereby reduces access to healthcare for women in need. Argentina, Burkina Faso, Thailand, and Vietnam are committed to reducing unnecessary CS, but many individual and organizational factors in healthcare facilities obstruct this aim. Nonclinical interventions can overcome these barriers by helping providers improve their practices and supporting women's decision-making regarding childbirth. Existing evidence has shown only a modest effect of single interventions on reducing CS rates, arguably because of the failure to design multifaceted interventions effectively tailored to the context. The aim of this study is to design, adapt, and test a multifaceted intervention for the appropriate use of CS in Argentina, Burkina Faso, Thailand, and Vietnam. METHODS: We designed an intervention (QUALIty DECision-making-QUALI-DEC) with four components: (1) opinion leaders at heathcare facilities to improve adherence to best practices among clinicians, (2) CS audits and feedback to help providers identify potentially avoidable CS, (3) a decision analysis tool to help women make an informed decision on the mode of birth, and (4) companionship to support women during labor. QUALI-DEC will be implemented and evaluated in 32 hospitals (8 sites per country) using a pragmatic hybrid effectiveness-implementation design to test our implementation strategy, and information regarding its impact on relevant maternal and perinatal outcomes will be gathered. The implementation strategy will involve the participation of women, healthcare professionals, and organizations and account for the local environment, needs, resources, and social factors in each country. DISCUSSION: There is urgent need for interventions and implementation strategies to optimize the use of CS while improving health outcomes and satisfaction in LMICs. This can only be achieved by engaging all stakeholders involved in the decision-making process surrounding birth and addressing their needs and concerns. The study will generate robust evidence about the effectiveness and the impact of this multifaceted intervention. It will also assess the acceptability and scalability of the intervention and the capacity for empowerment among women and providers alike. TRIAL REGISTRATION: ISRCTN67214403.

Optimising the use of caesarean section: a generic formative research protocol for implementation preparation.

BACKGROUND: Caesarean section rates are rising across all geographical regions. Very high rates for some groups of women co-occur with very low rates for others. Both extremes are associated with short and longer term harms. This is a major public health concern. Making the most effective use of caesarean section is a critical component of good quality, sustainable maternity care. In 2018, the World Health Organization published evidence-based recommendations on non-clinical interventions to reduce unnecessary caesarean section. The guideline identified critical research gaps and called for formative research to be conducted ahead of any interventional research to define locally relevant determinants of caesarean birth and factors that may affect implementation of multifaceted optimisation strategies. This generic formative research protocol is designed as a guide for contextual assessment and understanding for anyone planning to take action to optimise the use of caesarean section. METHODS: This formative protocol has three main components: (1) document review; (2) readiness assessment; and (3) primary qualitative research with women, healthcare providers and administrators. The document review and readiness assessment include tools for local mapping of policies, protocols, practices and organisation of care to describe and assess the service context ahead of implementation. The qualitative research is organized according to twelve identified interventions that may optimise use of caesarean section. Each intervention is designed as a "module" and includes a description of the intervention, supporting evidence, theory of change, and in-depth interview/focus group discussion guides. All study instruments are included in this protocol. DISCUSSION: This generic protocol is designed to underpin the formative stage of implementation research relating to optimal use of caesarean section. We encourage researchers, policy-makers and ministries of health to adapt and adopt this design to their context, and share their findings as a catalyst for rapid uptake of what works.

A cross-sectional audit showed that most Cochrane intervention reviews searched trial registers.

OBJECTIVE: The objective of this study was to assess current Cochrane Review practice in identifying and incorporating information from clinical trial registers. STUDY DESIGN AND SETTING: A cross-sectional study was conducted to assess a sample of new or updated intervention reviews from all Cochrane Review Groups up to February 1, 2017. Two assessors independently extracted data from each review using a pretested audit questionnaire. Data were analyzed relating to the frequency of reporting (1) the register source and search strategy; (2) the results of trial register searches; and (3) the use of trial register information in the review. RESULTS: Over 90% (236/260) of Cochrane Reviews reported searching a trial register (e.g., ClinicalTrials.gov or the WHO International Clinical Trials Registry Platform). In reviews that reported trial register searches, 39% (92/236) indicated the number of trial records retrieved and 56.8% (134/236) used information from the trial register records in the review. Trial record information was incorporated into the results (39.6%; 53/134), risk of bias assessments (53.7%; 72/134), and discussion (24.6%, 33/134) and conclusion sections (25.4%, 34/134). CONCLUSION: Most audited reviews used trial register information. Guidance may be needed to better incorporate information from these valuable resources in Cochrane Reviews to assist future research decisions made by funders and prospective study investigators.

Interventions to reduce unnecessary caesarean sections in healthy women and babies.

Optimising the use of caesarean section (CS) is of global concern. Underuse leads to maternal and perinatal mortality and morbidity. Conversely, overuse of CS has not shown benefits and can create harm. Worldwide, the frequency of CS continues to increase, and interventions to reduce unnecessary CSs have shown little success. Identifying the underlying factors for the continuing increase in CS use could improve the efficacy of interventions. In this Series paper, we describe the factors for CS use that are associated with women, families, health professionals, and health-care organisations and systems, and we examine behavioural, psychosocial, health system, and financial factors. We also outline the type and effects of interventions to reduce CS use that have been investigated. Clinical interventions, such as external cephalic version for breech delivery at term, vaginal breech delivery in appropriately selected women, and vaginal birth after CS, could reduce the frequency of CS use. Approaches such as labour companionship and midwife-led care have been associated with higher proportions of physiological births, safer outcomes, and lower health-care costs relative to control groups without these interventions, and with positive maternal experiences, in high-income countries. Such approaches need to be assessed in middle-income and low-income countries. Educational interventions for women should be complemented with meaningful dialogue with health professionals and effective emotional support for women and families. Investing in the training of health professionals, eliminating financial incentives for CS use, and reducing fear of litigation is fundamental. Safe, private, welcoming, and adequately resourced facilities are needed. At the country level, effective medical leadership is essential to ensure CS is used only when indicated. We conclude that interventions to reduce overuse must be multicomponent and locally tailored, addressing women's and health professionals' concerns, as well as health system and financial factors.

Non-clinical interventions for reducing unnecessary caesarean section.

BACKGROUND: Caesarean section rates are increasing globally. The factors contributing to this increase are complex, and identifying interventions to address them is challenging. Non-clinical interventions are applied independently of a clinical encounter between a health provider and a patient. Such interventions may target women, health professionals or organisations. They address the determinants of caesarean births and could have a role in reducing unnecessary caesarean sections. This review was first published in 2011. This review update will inform a new WHO guideline, and the scope of the update was informed by WHO's Guideline Development Group for this guideline. OBJECTIVES: To evaluate the effectiveness and safety of non-clinical interventions intended to reduce unnecessary caesarean section. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and two trials registers in March 2018. We also searched websites of relevant organisations and reference lists of related reviews. SELECTION CRITERIA: Randomised trials, non-randomised trials, controlled before-after studies, interrupted time series studies and repeated measures studies were eligible for inclusion. The primary outcome measures were: caesarean section, spontaneous vaginal birth and instrumental birth. DATA COLLECTION AND ANALYSIS: We followed standard methodological procedures recommended by Cochrane. We narratively described results of individual studies (drawing summarised evidence from single studies assessing distinct interventions). MAIN RESULTS: We included 29 studies in this review (19 randomised trials, 1 controlled before-after study and 9 interrupted time series studies). Most of the studies (20 studies) were conducted in high-income countries and none took place in low-income countries. The studies enrolled a mixed population of pregnant women, including nulliparous women, multiparous women, women with a fear of childbirth, women with high levels of anxiety and women having undergone a previous caesarean section.Overall, we found low-, moderate- or high-certainty evidence that the following interventions have a beneficial effect on at least one primary outcome measure and no moderate- or high-certainty evidence of adverse effects.Interventions targeted at women or familiesChildbirth training workshops for mothers alone may reduce caesarean section (risk ratio (RR) 0.55, 95% confidence interval (CI) 0.33 to 0.89) and may increase spontaneous vaginal birth (RR 2.25, 95% CI 1.16 to 4.36). Childbirth training workshops for couples may reduce caesarean section (RR 0.59, 95% CI 0.37 to 0.94) and may increase spontaneous vaginal birth (RR 2.13, 95% CI 1.09 to 4.16). We judged this one study with 60 participants to have low-certainty evidence for the outcomes above.Nurse-led applied relaxation training programmes (RR 0.22, 95% CI 0.11 to 0.43; 104 participants, low-certainty evidence) and psychosocial couple-based prevention programmes (RR 0.53, 95% CI 0.32 to 0.90; 147 participants, low-certainty evidence) may reduce caesarean section. Psychoeducation may increase spontaneous vaginal birth (RR 1.33, 95% CI 1.11 to 1.61; 371 participants, low-certainty evidence). The control group received routine maternity care in all studies.There were insufficient data on the effect of the four interventions on maternal and neonatal mortality or morbidity.Interventions targeted at healthcare professionalsImplementation of clinical practice guidelines combined with mandatory second opinion for caesarean section indication slightly reduces the risk of overall caesarean section (mean difference in rate change -1.9%, 95% CI -3.8 to -0.1; 149,223 participants). Implementation of clinical practice guidelines combined with audit and feedback also slightly reduces the risk of caesarean section (risk difference (RD) -1.8%, 95% CI -3.8 to -0.2; 105,351 participants). Physician education by local opinion leader (obstetrician-gynaecologist) reduced the risk of elective caesarean section to 53.7% from 66.8% (opinion leader education: 53.7%, 95% CI 46.5 to 61.0%; control: 66.8%, 95% CI 61.7 to 72.0%; 2496 participants). Healthcare professionals in the control groups received routine care in the studies. There was little or no difference in maternal and neonatal mortality or morbidity between study groups. We judged the certainty of evidence to be high.Interventions targeted at healthcare organisations or facilitiesCollaborative midwifery-labourist care (in which the obstetrician provides in-house labour and delivery coverage, 24 hours a day, without competing clinical duties), versus a private practice model of care, may reduce the primary caesarean section rate. In one interrupted time series study, the caesarean section rate decreased by 7% in the year after the intervention, and by 1.7% per year thereafter (1722 participants); the vaginal birth rate after caesarean section increased from 13.3% before to 22.4% after the intervention (684 participants). Maternal and neonatal mortality were not reported. We judged the certainty of evidence to be low.We studied the following interventions, and they either made little or no difference to caesarean section rates or had uncertain effects.Moderate-certainty evidence suggests little or no difference in caesarean section rates between usual care and: antenatal education programmes for physiologic childbirth; antenatal education on natural childbirth preparation with training in breathing and relaxation techniques; computer-based decision aids; individualised prenatal education and support programmes (versus written information in pamphlet).Low-certainty evidence suggests little or no difference in caesarean section rates between usual care and: psychoeducation; pelvic floor muscle training exercises with telephone follow-up (versus pelvic floor muscle training without telephone follow-up); intensive group therapy (cognitive behavioural therapy and childbirth psychotherapy); education of public health nurses on childbirth classes; role play (versus standard education using lectures); interactive decision aids (versus educational brochures); labourist model of obstetric care (versus traditional model of obstetric care).We are very uncertain as to the effect of other interventions identified on caesarean section rates as the certainty of the evidence is very low. AUTHORS' CONCLUSIONS: We evaluated a wide range of non-clinical interventions to reduce unnecessary caesarean section, mostly in high-income settings. Few interventions with moderate- or high-certainty evidence, mainly targeting healthcare professionals (implementation of guidelines combined with mandatory second opinion, implementation of guidelines combined with audit and feedback, physician education by local opinion leader) have been shown to safely reduce caesarean section rates. There are uncertainties in existing evidence related to very-low or low-certainty evidence, applicability of interventions and lack of studies, particularly around interventions targeted at women or families and healthcare organisations or facilities.