Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage.

BACKGROUND: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle. METHODS: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle. RESULTS: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28). CONCLUSIONS: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery. (Funded by the Bill and Melinda Gates Foundation; E-MOTIVE ClinicalTrials.gov number, NCT04341662.).

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.

BACKGROUND: Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal-fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. METHODS AND FINDINGS: We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women's decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women's willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention's risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women's participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. CONCLUSIONS: This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women's engagement, participation, and trust in such trials.

An investigation into the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companionship in Tehran: a qualitative inquiry on mitigating mistreatment of women during childbirth.

BACKGROUND: A birth companion is a powerful mechanism for preventing mistreatment during childbirth and is a key component of respectful maternity care (RMC). Despite a growing body of evidence supporting the benefits of birth companions in enhancing the quality of care and birth experience, the successful implementation of this practice continues to be a challenge, particularly in developing countries. Our aim was to investigate the acceptability, adoption, appropriateness, feasibility, and fidelity of implementation strategies for birth companions to mitigate the mistreatment of women during childbirth in Tehran. METHODS: This exploratory descriptive qualitative study was conducted between April and August 2023 at Valiasr Hospital in Tehran, Iran. Fifty-two face-to-face in-depth interviews were conducted with a purposive sample of women, birth companions, and maternity healthcare providers. Interviews were audio-recorded, transcribed verbatim, and analyzed using content analysis, with a deductive approach based on the Implementation Outcomes Framework in the MAXQDA 18. RESULTS: Participants found the implemented program to be acceptable and beneficial, however the implementation team noticed that some healthcare providers were initially reluctant to support it and perceived it as an additional burden. However, its adoption has increased over time. Healthcare providers felt that the program was appropriate and feasible, and it improved satisfaction with care and the birth experience. Participants, however, highlighted several issues that need to be addressed. These include the need for training birth companions prior to entering the maternity hospital, informing women about the role of birth companions, assigning a dedicated midwife to provide training, and addressing any physical infrastructure concerns. CONCLUSION: Despite some issues raised by the participants, the acceptability, adoption, appropriateness, feasibility, and fidelity of the implementation strategies for birth companions to mitigate the mistreatment of women during childbirth were well received. Future research should explore the sustainability of this program. The findings of this study can be used to support the implementation of birth companions in countries with comparable circumstances.

Challenges to the implementation of a multi-level intervention to reduce mistreatment of women during childbirth in Iran: a qualitative study using the Consolidated Framework for Implementation Research.

BACKGROUND: Mistreatment during childbirth is a growing concern worldwide, especially in developing countries, such as Iran. In response, we launched a comprehensive implementation research (IR) project to reduce mistreatment during childbirth and enhance positive birth experiences in birth facilities. This study identified the challenges of implementing a multi-level intervention to reduce mistreatment of women during childbirth using the Consolidated Framework for Implementation Research (CFIR). METHODS: An exploratory qualitative study, involving 30 in-depth interviews, was conducted between July 2022 and February 2023. Participants included a purposive sample of key stakeholders at different levels of the health system (macro: Ministry of Health and Medical Education; meso: universities of medical sciences and health services; and micro: hospitals) with sufficient knowledge, direct experience, and/or collaboration in the implementation of the studied interventions. Interviews were transcribed verbatim and coded using directed qualitative content analysis (CFIR constructs) in MAXQDA 18. RESULTS: The identified challenges were: (1) individual level (childbirth preparation classes: e.g., adaptability, design quality and packaging, cosmopolitanism; presence of birth companions: e.g., patient needs and resources, structural characteristics, culture); (2) healthcare provider level (integrating respectful maternity care into in-service training: e.g., relative priority, access to knowledge and information, reflecting and evaluating); (3) hospital level (evaluating the performance of maternity healthcare providers: e.g., executing, external policies and incentives); and (4) national health system level (implementation of pain relief during childbirth guidelines: e.g., networks and communications, patient needs and resources, executing, reflecting and evaluating). CONCLUSIONS: This study provides a clear understanding of the challenges of implementing a multi-level intervention to reduce mistreatment of women during childbirth and highlights potential implications for policy makers and practitioners of maternal health programs. We encourage them to take the lessons learned from this study and revise their current programs and policies regarding the quality of maternity care by focusing on the identified challenges.

Evidence suggests that mistreatment during childbirth is a growing concern worldwide, especially in developing countries, such as Iran. In this qualitative study, through 30 in-depth interviews with key stakeholders at different levels of the health system (macro: Ministry of Health and Medical Education; meso: universities of medical sciences and health services; and micro: hospitals), we identified the challenges of implementing a multi-level intervention to reduce mistreatment of women during childbirth using the Consolidated Framework for Implementation Research (CFIR). The data were analyzed using directed content analysis and a deductive approach in MAXQDA 18 software. The identified challenges were: (1) individual level (childbirth preparation classes: e.g., adaptability; presence of birth companions: e.g., patient needs and resources); (2) healthcare provider level (integrating respectful maternity care into in-service training: e.g., relative priority); (3) hospital level (evaluating the performance of maternity healthcare providers: e.g., executing, external policies and incentives); and (4) national health system level (implementation of pain relief childbirth guidelines: e.g., networks and communications). This study provides a clear understanding of the challenges of implementing a multi-level intervention to reduce mistreatment of women during childbirth; and highlights potential implications for policy makers and practitioners of maternal health programs.

'If we take the engine out, how will the car go?': beliefs, understanding and access to vasectomy services in Timor-Leste.

Vasectomy is a safe, highly effective and affordable method of permanent contraception, and one of the few currently available contraceptive methods for men. Despite this, vasectomy uptake remains overall low, making up just 2% of the global contraceptive method mix. To better understand access to vasectomy in a country with negligible uptake, we conducted participatory and operational research in the Democratic Republic of Timor-Leste (Timor-Leste). We held 14 participatory group discussions with 175 community participants (84 men, 91 women; aged 18-72) across seven municipalities (Ainaro, Baucau, Bobonaro, Dili, Lautem, Manufahi, and Oecusse), and individual in-depth interviews with 24 healthcare providers (16 women, 8 men; aged 25-56 years). Data were analysed using reflexive thematic analysis. Community awareness and understanding about vasectomy were limited, with concerns expressed about physical and social side effects. Healthcare providers had limited experience and knowledge about vasectomy, and about male sexual and reproductive health more generally. However, our findings also indicate a small but existing demand for vasectomy services that could be grown and better met through health systems strengthening initiatives. Insights from our research have informed programmatic decision-making in Timor-Leste and can be further used to inform national health policy and practice.

Perceptions and experiences of the prevention, detection, and management of postpartum haemorrhage: a qualitative evidence synthesis.

BACKGROUND: Postpartum haemorrhage (PPH), defined as blood loss of 500 mL or more after childbirth, is the leading cause of maternal mortality worldwide. It is possible to prevent complications of PPH with timely and appropriate detection and management. However, implementing the best methods of PPH prevention, detection and management can be challenging, particularly in low- and middle-income countries. OBJECTIVES: Our overall objective was to explore the perceptions and experiences of women, community members, lay health workers, and skilled healthcare providers who have experience with PPH or with preventing, detecting, and managing PPH, in community or health facility settings. SEARCH METHODS: We searched MEDLINE, CINAHL, Scopus, and grey literature on 13 November 2022 with no language restrictions. We then performed reference checking and forward citation searching of the included studies. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that explored perceptions and experiences of PPH prevention, detection, and management among women, community members, traditional birth attendants, healthcare providers, and managers. DATA COLLECTION AND ANALYSIS: We used three-stage maximum variation sampling to ensure diversity in terms of relevance of the study to the review objectives, richness of data, and coverage of critical contextual elements: setting (region, country income level), perspective (type of participant), and topic (prevention, detection, management). We extracted data using a data extraction form designed for this review. We used thematic synthesis to analyse and synthesise the evidence, and we used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. To identify factors that may influence intervention implementation, we mapped each review finding to the Theoretical Domains Framework (TDF) and the Capability, Motivation, and Opportunity model of Behaviour change (COM-B). We used the Behaviour Change Wheel to explore implications for practice. MAIN RESULTS: We included 67 studies and sampled 43 studies for our analysis. Most were from low- or middle-income countries (33 studies), and most included the perspectives of women and health workers. We downgraded our confidence in several findings from high confidence to moderate, low, or very-low confidence, mainly due to concerns about how the studies were conducted (methodological limitations) or concerns about missing important perspectives from some types of participants or in some settings (relevance). In many communities, bleeding during and after childbirth is considered "normal" and necessary to expel "impurities" and restore and cleanse the woman's body after pregnancy and birth (moderate confidence). In some communities, people have misconceptions about causes of PPH or believe that PPH is caused by supernatural powers or evil spirits that punish women for ignoring or disobeying social rules or for past mistakes (high confidence). For women who give birth at home or in the community, female family members or traditional birth attendants are the first to recognise excess bleeding after birth (high confidence). Family members typically take the decision of whether and when to seek care if PPH is suspected, and these family members are often influenced by trusted traditional birth attendants or community midwives (high confidence). If PPH is identified for women birthing at home or in the community, decision-making about the subsequent referral and care pathway can be multifaceted and complex (high confidence). First responders to PPH are not always skilled or trained healthcare providers (high confidence). In health facilities, midwives may consider it easy to implement visual estimation of blood loss with a kidney dish or under-pad, but difficult to accurately interpret the amount of blood loss (very low confidence). Quantifying (rather than estimating) blood loss may be a complex and contentious change of practice for health workers (low confidence). Women who gave birth in health facilities and experienced PPH described it as painful, embarrassing, and traumatic. Partners or other family members also found the experience stressful. While some women were dissatisfied with their level of involvement in decision-making for PPH management, others felt health workers were best placed to make decisions (moderate confidence). Inconsistent availability of resources (drugs, medical supplies, blood) causes delays in the timely management of PPH (high confidence). There is limited availability of misoprostol in the community owing to stockouts, poor supply systems, and the difficulty of navigating misoprostol procurement for community health workers (moderate confidence). Health workers described working on the maternity ward as stressful and intense due to short staffing, long shifts, and the unpredictability of emergencies. Exhausted and overwhelmed staff may be unable to appropriately monitor all women, particularly when multiple women are giving birth simultaneously or on the floor of the health facility; this could lead to delays in detecting PPH (moderate confidence). Inadequate staffing, high turnover of skilled health workers, and appointment of lower-level cadres of health workers are key challenges to the provision of quality PPH care (high confidence). Through team-based simulation training, health workers of different cadres (doctors, midwives, lay health workers) can develop a shared mental model to help them work quickly, efficiently, and amicably as a team when managing women with PPH (moderate confidence). AUTHORS' CONCLUSIONS: Our findings highlight how improving PPH prevention, detection, and management is underpinned by a complex system of interacting roles and behaviours (community, women, health workers of different types and with different experiences). Multiple individual, sociocultural, and environmental factors influence the decisions and behaviours of women, families, communities, health workers, and managers. It is crucial to consider the broader health and social systems when designing and implementing PPH interventions to change or influence these behaviours. We have developed a set of prompts that may help programme managers, policymakers, researchers, and other key stakeholders to identify and address factors that affect implementation and scale-up of interventions to improve PPH prevention, detection, and management.

"Because it eases my Childbirth Plan": a qualitative study on factors contributing to preferences for caesarean section in Thailand.

BACKGROUND: Although caesarean section (CS) rates have increased rapidly in Thailand, the upward trend is not supported by significant maternal or perinatal health benefits. The appropriate use of CS through QUALIty DECision-making by women and providers (QUALI-DEC project) aims to design and implement a strategy to optimize the use of CS through non-clinical interventions. This study aimed to explore the factors influencing women's and health professionals' preferences for CS delivery in Thailand. METHODS: We conducted a formative qualitative study by using semi-structured in-depth interviews with pregnant and postpartum women, and healthcare staff. Purposive sampling was used to recruit participants from eight hospitals across four regions of Thailand. Content analysis was used to develop the main themes. RESULTS: There were 78 participants, including 27 pregnant and 25 postpartum women, 8 administrators, 13 obstetricians, and 5 interns. We identified three main themes and seven sub-themes of women and healthcare providers' perceptions on CS: (1) avoiding the negative experiences from vaginal birth (the pain of labor and childbirth, uncertainty during the labor period); (2) CS is a safer mode of birth (guarantees the baby's safety, a protective shield for doctors); and (3) CS facilitates time management (baby's destiny at an auspicious time, family's management, manage my work/time). CONCLUSIONS: Women mentioned negative experiences and beliefs about vaginal delivery, labor pain, and uncertain delivery outcomes as important factors influencing CS preferences. On the other hand, CS is safer for babies and facilitates multiple tasks in women's lives. From health professionals' perspectives, CS is the easier and safer method for patients and them. Interventions to reduce unnecessary CS, including QUALI-DEC, should be designed and implemented, taking into consideration the perceptions of both women and healthcare providers.

E. coli contamination of drinking water sources in rural and urban settings: an analysis of 38 nationally representative household surveys (2014-2021).

The world is not on track to achieve universal access to safely managed water by 2030, and access is substantially lower in rural areas. This Sustainable Development Goal target and many other global indicators rely on the classification of improved water sources for monitoring access. We aimed to investigate contamination in drinking water sources, comparing improved and unimproved sources in urban and rural settings. We used data from Multiple Indicator Cluster Surveys, which tested samples from the household water source and a glass of water for Escherichia coli contamination across 38 countries. Contamination was widespread and alarmingly high in almost all countries, settings, and water sources, with substantial inequalities between and within countries. Water contamination was found in 51.7% of households at the source and 70.8% in the glass of water. Some improved sources (e.g., protected wells and rainwater) were as likely to be contaminated as unimproved sources. Some sources, like piped water, were considerably more likely to be contaminated in rural than urban areas, while no difference was observed for others. Monitoring water contamination along with further investigation in water collection, storage, and source classification is essential and must be expanded to achieve universal access to safely managed water.

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.

Community perspectives and experiences of quality maternal and newborn care in East New Britain, Papua New Guinea.

BACKGROUND: Quality maternal and newborn care is essential for improving the health of mothers and babies. Low- and middle-income countries, such as Papua New Guinea (PNG), face many barriers to achieving quality care for all. Efforts to improve the quality of maternal and newborn care must involve community in the design, implementation, and evaluation of initiatives to ensure that interventions are appropriate and relevant for the target community. We aimed to describe community members' perspectives and experiences of maternal and newborn care, and their ideas for improvement in one province, East New Britain, in PNG. METHODS: We undertook a qualitative descriptive study in partnership with and alongside five local health facilities, health care workers and community members, using a Partnership Defined Quality Approach. We conducted ten focus group discussions with 68 community members (identified through church, market and other community-based groups) in East New Britain PNG to explore perspectives and experiences of maternal and newborn care, identify enablers and barriers to quality care and interventions to improve care. Discussions were transcribed verbatim. A mixed inductive and deductive analysis was conducted including application of the World Health Organisation (WHO) Quality Maternal and Newborn Care framework. RESULTS: Using the WHO framework, we present the findings in accordance with the five experience of care domains. We found that the community reported multiple challenges in accessing care and facilities were described as under-staffed and under resourced. Community members emphasised the importance of good communication and competent, caring and respectful healthcare workers. Both women and men expressed a strong desire for companionship during labor and birth. Several changes were suggested by the community that could immediately improve the quality of care. CONCLUSIONS: Community perspectives and experiences are critical for informing effective and sustainable interventions to improve the quality of maternal and newborn care and increasing facility-based births in PNG. A greater understanding of the care experience as a key component of quality care is needed and any quality improvement initiatives must include the user experience as a key outcome measure.

Improving the care provided to, and experienced by, women and their families during pregnancy and childbirth is important for improving the health of mothers and babies. Community members should be involved in thinking about appropriate ways to improve care. Papua New Guinea (PNG) is a country in the Pacific which faces multiple challenges to improving care during pregnancy and birth. We aimed to understand what community members think about care provided and experienced during labour and birth in East New Britain, a rural province of PNG. We worked with five health facilities, health workers and community members in East New Britain to develop a qualitative research project. We carried out 10 focus group discussions with community members in East New Britain to understand what the provision and experience of care was like during labour and birth, and ways that it could be improved. We found that community members identified multiple challenges in getting to facilities and many facilities were found to have not enough supplies, equipment, or staff. Community members wanted staff that were good at their work but also caring and respectful. Women wanted to have support people present during labour and birth and many men wanted to be present too. Our results show that it is important to understand what the community thinks about the quality of care during labour and birth and this information is helpful to design effective activities to improve the care provided and experienced.

Measuring women's experiences during antenatal care (ANC): scoping review of measurement tools.

BACKGROUND: The new WHO model for antenatal care (ANC) focuses on improving practice, organisation and delivery of ANC within health systems, which includes both clinical care and women's experiences of care. The goal of this review is to identify tools and measures on women's experiences of ANC. METHODS: We conducted a scoping review to identify tools and measures on women's experiences of ANC. An iterative approach was used to review all tools in a series of four steps: (1) identify papers between 2007 and 2023; (2) identify the tools from these papers; (3) map relevant measures to conceptualizations of experiences of care, notably mistreatment of women and respectful maternity care and (4) identify gaps and opportunities to improve measures. RESULTS: Across the 36 tools identified, a total of 591 measures were identified. Of these, 292/591 (49.4%) measures were included and mapped to the typology of mistreatment of women used as a definition for women's experiences care during ANC in this review, while 299/591 (44.9%) irrelevant measures were excluded. Across the included measures, the highest concentration was across the domains of poor rapport between women and providers (49.8%) followed by failure to meet professional standards of care (23.3%). Approximately, 13.9% of measures were around overall respectful care, followed by health systems (6.3%), and any  physical or verbal abuse, stigma and/or discrimination (4.8%) . CONCLUSION: This analysis provides an overview of the existing tools, gaps and opportunities to measure women's experiences during ANC. Expanding beyond the childbirth period, these findings can be used to inform existing and future tools for research and monitoring measuring women's experiences of ANC.

Mistreatment of women during childbirth and its influencing factors in public maternity hospitals in Tehran, Iran: a multi-stakeholder qualitative study.

BACKGROUND: Mistreatment during labour and childbirth is a common experience for many women around the world. This study aimed to explore the manifestations of mistreatment and its influencing factors in public maternity hospitals in Tehran. METHODS: A formative qualitative study was conducted using a phenomenological approach in five public hospitals between October 2021 and May 2022. Sixty in-depth face-to-face interviews were conducted with a purposive sample of women, maternity healthcare providers, and managers. Data were analyzed with content analysis using MAXQDA 18. RESULTS: Mistreatment of women during labour and childbirth was manifested in four form: (1) physical abuse (fundal pressure); (2) verbal abuse (judgmental comments, harsh and rude language, and threats of poor outcomes); (3) failure to meet professional standards of care (painful vaginal exams, neglect and abandonment, and refusal to provide pain relief); and (4) poor rapport between women and providers (lack of supportive care and denial of mobility). Four themes were also identified as influencing factors: (1) individual-level factors (e.g., providers' perception about women's limited knowledge on childbirth process), (2) healthcare provider-level factors (e.g., provider stress and stressful working conditions); (3) hospital-level factors (e.g., staff shortages); and (4) national health system-level factors (e.g., lack of access to pain management during labour and childbirth). CONCLUSIONS: Our study showed that women experienced various forms of mistreatment during labour and childbirth. There were also multiple level drivers for mistreatment at individual, healthcare provider, hospital and health system levels. Addressing these factors requires urgent multifaceted interventions.

Mistreatment during labour and childbirth is a common experience for many women around the world. A picture of the nature and types of mistreatment; and especially its influencing factors has not yet been identified in Iran. A qualitative approach to explore manifestations of mistreatment during labour and childbirth while learning about the factors that influence them was used for this study. It obtained this information thanks to semi-structured interviews with women, maternity healthcare providers, and managers between October 2021 and May 2022. Our findings showed that women experienced various forms of mistreatment during labour and childbirth. At individual level, e.g., providers' perception about women's limited knowledge on childbirth process was an influencing factor for mistreatment. At healthcare provider level, a highlighted factor was provider stress and stressful working conditions. At hospital level, e.g., staff shortages played a main role; and at national health system level, participants believed that lack of access to pain management during labour and childbirth was an influencing factor for mistreatment. These findings can provide a good platform for designing and implementing intervention programs to reduce disrespectful maternity care. It can also be used as a guide for managers and policymakers to improve the quality of services provided to women.

Women's and health providers' perceptions of companionship during labor and childbirth: a formative study for the implementation of WHO companionship model in Burkina Faso.

INTRODUCTION: A key component of achieving respectful maternal and newborn care is labor companionship. Despite important health benefits for the woman and baby, there are critical gaps in implementing labor companionship for all women globally. The paper aims to present the perceptions and experiences of pregnant women, postpartum women, and health care providers regarding companionship during labor and childbirth, and to identify barriers and facilitating factors to the implementation of labor companionship in Burkina Faso. METHODS: This is a formative study to inform the "Appropriate use of cesarean section through QUALIty DECision-making by women and providers" (QUALI-DEC) study, to design, adapt and implement a strategy to optimize the use of the cesarean section, including labor companionship. We use in-depth interviews (women, potential companions, and health workers) and health facility readiness assessments in eight hospitals across Burkina Faso. We use a thematic analysis approach for interviews, and narrative summaries to describe facility readiness assessment. RESULTS: In all, 77 qualitative interviews and eight readiness assessments are included in this analysis. The findings showed that all participants acknowledged an existing traditional companionship model, which allowed companions to support women only in the hospital waiting room and post-natal room. Despite recognizing clear benefits, participants were not familiar with companionship during labor and childbirth in the hospital as recommended by WHO. Key barriers to implementing companionship throughout labor and birth include limited space in labor and delivery wards, no private rooms for women, hospital rules preventing companionship, and social norms preventing the choice of a companion by the woman. CONCLUSION: Labor companionship was considered highly acceptable in Burkina Faso, but more work is needed to adapt to the hospital environment. Revisions to hospital policies to allow companions during labor and childbirth are needed as well as changes to provide private space for women. Training potential companions about their roles and encouraging women's rights to choose their companions may help to facilitate effective implementation.

A labor companion is a person who supports a woman throughout labor and birth, typically a woman's spouse/partner, family member, or friend. We were interested to explore if a labor companion throughout labor and birth was acceptable to women and health workers, and feasible to start doing for women in Burkina Faso. To achieve this objective, we interviewed 77 women, companions, and health workers about their beliefs and opinions about labor companions, and what might help or be a challenge to having companions. We also visited eight hospitals to understand what the labor ward looks like, and any policies about companions. We found that hospitals were allowing a 'traditional model' of companionship, allowing companions to accompany women only in the waiting and postnatal rooms (not during labor or birth). Both women and health workers believed that companionship during labor and birth would be helpful and desired, which might help to make it a reality for all women. We also identified some challenges, due to crowded labor rooms with limited privacy, and hospital rules that did not allow companionship. We found that sometimes a woman's family would choose the companion, instead of the woman herself, which may mean the woman does not want this person present. We plan to use these findings to help us to develop a program that allows any woman to have a companion present during labor and birth, in a way that ensures that she chooses the companion, and the companion can support her well.

The use of GRADE-CERQual in qualitative evidence synthesis: an evaluation of fidelity and reporting.

BACKGROUND: GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) is a methodological approach to systematically and transparently assess how much confidence decision makers can place in individual review findings from qualitative evidence syntheses. The number of reviews applying GRADE-CERQual is rapidly expanding in guideline and other decision-making contexts. The objectives of this evaluation were, firstly, to describe the uptake of GRADE-CERQual in qualitative evidence synthesis by review authors and, secondly, to assess both reporting of and fidelity to the approach. METHODS: The evaluation had two parts. Part 1 was a citation analysis and descriptive overview of the literature citing GRADE-CERQual. Authors worked together to code and chart the citations, first by title and abstract and second by full text. Part 2 was an assessment and analysis of fidelity to, and reporting of, the GRADE-CERQual approach in included reviews. We developed fidelity and reporting questions and answers based on the most recent guidance for GRADE-CERQual and then used NVivo12 to document assessments in a spreadsheet and code full-text PDF articles for any concerns that had been identified. Our assessments were exported to Excel and we applied count formulae to explore patterns in the data. We employed a qualitative content analysis approach in NVivo12 to sub-coding all the data illustrating concerns for each reporting and fidelity criteria. RESULTS: 233 studies have applied the GRADE-CERQual approach, with most (n = 225, 96.5%) in the field of health research. Many studies (n = 97/233, 41.6%) were excluded from full fidelity and reporting assessment because they demonstrated a serious misapplication of GRADE-CERQual, for example interpreting it as a quality appraisal tool for primary studies or reviews. For the remaining studies that applied GRADE-CERQual to assess confidence in review findings, the main areas of reporting concern involved terminology, labelling and completeness. Fidelity concerns were identified in more than half of all studies assessed. CONCLUSIONS: GRADE-CERQual is being used widely within qualitative evidence syntheses and there are common reporting and fidelity issues. Most of these are avoidable and we highlight these as gaps in knowledge and guidance for applying the GRADE-CERQual approach.

Factors influencing appropriate use of interventions for management of women experiencing preterm birth: A mixed-methods systematic review and narrative synthesis.

BACKGROUND: Preterm birth-related complications are the leading cause of death in newborns and children under 5. Health outcomes of preterm newborns can be improved with appropriate use of antenatal corticosteroids (ACSs) to promote fetal lung maturity, tocolytics to delay birth, magnesium sulphate for fetal neuroprotection, and antibiotics for preterm prelabour rupture of membranes. However, there are wide disparities in the rate and consistency in the use of these interventions across settings, which may underlie the differential health outcomes among preterm newborns. We aimed to assess factors (barriers and facilitators) affecting the appropriate use of ACS, tocolytics, magnesium sulphate, and antibiotics to improve preterm birth management. METHODS AND FINDINGS: We conducted a mixed-methods systematic review including primary qualitative, quantitative, and mixed-methods studies. We searched MEDLINE, EMBASE, CINAHL, Global Health, and grey literature from inception to 16 May 2022. Eligible studies explored perspectives of women, partners, or community members who experienced preterm birth or were at risk of preterm birth and/or received any of the 4 interventions, health workers providing maternity and newborn care, and other stakeholders involved in maternal care (e.g., facility managers, policymakers). We used an iterative narrative synthesis approach to analysis, assessed methodological limitations using the Mixed Methods Appraisal Tool, and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. Behaviour change models (Theoretical Domains Framework; Capability, Opportunity, and Motivation (COM-B)) were used to map barriers and facilitators affecting appropriate use of these interventions. We included 46 studies from 32 countries, describing factors affecting use of ACS (32/46 studies), tocolytics (13/46 studies), magnesium sulphate (9/46 studies), and antibiotics (5/46 studies). We identified a range of barriers influencing appropriate use of the 4 interventions globally, which include the following: inaccurate gestational age assessment, inconsistent guidelines, varied knowledge, perceived risks and benefits, perceived uncertainties and constraints in administration, confusion around prescribing and administering authority, and inadequate stock, human resources, and labour and newborn care. Women reported hesitancy in accepting interventions, as they typically learned about them during emergencies. Most included studies were from high-income countries (37/46 studies), which may affect the transferability of these findings to low- or middle-income settings. CONCLUSIONS: In this study, we identified critical factors affecting implementation of 4 interventions to improve preterm birth management globally. Policymakers and implementers can consider these barriers and facilitators when formulating policies and planning implementation or scale-up of these interventions. Study findings can inform clinical preterm birth guidelines and implementation to ensure that barriers are addressed, and enablers are reinforced to ensure these interventions are widely available and appropriately used globally.

Correction: Factors influencing appropriate use of interventions for management of women experiencing preterm birth: A mixed-methods systematic review and narrative synthesis.

[This corrects the article DOI: 10.1371/journal.pmed.1004074.].

Measuring user experience of care among caregivers of sick children: Validation and descriptive analysis in a sample of 75 health facilities in rural Tanzania.

OBJECTIVE: User experience is an important aspect of quality of care that is highly valued by patients. However, there are currently no validated tools for measuring user experience among caregivers of sick children in low- and middle-income countries. We aimed to develop and validate a measure of user experience in this population in primary healthcare facilities in rural Tanzania, where major quality improvement efforts to date have not included a large focus on user experience. We then aimed to describe variation in user experience between and within facilities. METHODS: Informed by theory and formative qualitative research, we developed questions to measure user experience across three domains: prompt care, respect, and communication. We then conducted interviewer-administered surveys with caregivers of sick children. Using survey data, we conducted psychometric analyses to inform the development of a composite measure of user experience. Finally, we used multilevel models to describe variation in user experience and examine associations with facility, patient, and caregiver characteristics. RESULTS: Surveys were completed by 1085 caregivers across 75 facilities. In exploratory factor analysis, user experience items did not group according to theoretical domains. We therefore assessed items individually and designed a single 8-item additive measure of user experience. Using this composite measure, and adjusting for differences in case mix across facilities, we found that 69% of variation in user experience was within facilities and 31% was between facilities. Smaller facility size and more caregiver education were positively associated with user experience. CONCLUSIONS: We found that user experience varied significantly across health facilities in rural Tanzania, highlighting opportunities for improvement. Measurement tools are needed to inform efforts to improve user experience and monitor changes over time. The scale developed in this study could serve as a starting point for the measurement of user experience among caregivers in similar settings.

Fentanyl for labour pain management: a scoping review.

BACKGROUND: Labour pain has been identified as an important reason for women to prefer caesarean section (CS). Fentanyl is one of the short acting opioids recommended by World Health Organization for pain relief during labour. This study aimed to identify and describe the available evidence on the use of fentanyl (monotherapy) for labour pain management by any routes of administration or regime. METHODS: We included the records published until 31 December 2021 which reported administration of fentanyl to women with normal labour for labour pain relief. Data were extracted by one reviewer and checked by another reviewer using a standardised agreement form. We mapped and presented data descriptively in figure and tabular format. RESULTS: We included 51 records from 49 studies in our scoping review. The studies were conducted in 12 countries, mostly high-income countries. The study designs of the 51 included records were varied as follows: 38 (74.5%) experimental studies (35 randomised controlled trials and three quasi-experimental studies), and 12 (23.5%) observational studies (five retrospective cohort studies, four prospective cohort studies, two retrospective descriptive studies, and one descriptive study) and one qualitative study. Of the included records, six used intranasal fentanyl, five used subcutaneous fentanyl, 18 (35.3%) used intravenous fentanyl, 18 (35.3%) used intrathecal fentanyl, and nine used epidural fentanyl. Many records compared fentanyl with another analgesic agent while five records (9.8%) had no comparison group and seven records (13.7%) compared with no analgesia group. The doses of fentanyl varied by routes, study and the requirement depended on the women. Pain assessment was the most frequent outcome measure presented in the records (78.4%). Only nine records (17.6%) investigated women's satisfaction about labour pain relief using fentanyl and seven records (13.7%) reported the effect of fentanyl on breastfeeding. The most common reported neonatal outcomes were foetal heart rate (33 records, 64.7%) and Apgar score (32 records, 62.7%). CONCLUSION: There is limited primary evidence especially randomised controlled trials to evaluate the effectiveness and harms of different routes of fentanyl in low- or middle-income countries. There is a need for high-quality research to establish the most effective route of fentanyl and associated effects for evidence-based international guidelines.

Quality newborn care in East New Britain, Papua New Guinea: measuring early newborn care practices and identifying opportunities for improvement.

BACKGROUND: Renewed attention and investment is needed to improve the quality of care during the early newborn period to address preventable newborn deaths and stillbirths in Papua New Guinea (PNG). We aimed to assess early newborn care practices and identify opportunities for improvement in one province (East New Britain) in PNG. METHODS: A mixed-methods study was undertaken in five rural health facilities in the province using a combination of facility audits, labour observations and qualitative interviews with women and maternity providers. Data collection took place between September 2019 and February 2020. Quantitative data were analysed descriptively, whilst qualitative data were analysed using content analysis. Data were triangulated by data source. RESULTS: Five facility audits, 30 labour observations (in four of the facilities), and interviews with 13 women and eight health providers were conducted to examine early newborn care practices. We found a perinatal mortality rate of 32.2 perinatal deaths per 1000 total births and several barriers to quality newborn care, including an insufficient workforce, critical infrastructure and utility constraints, and limited availability of essential newborn medicines and equipment. Most newborns received at least one essential newborn care practice in the first hour of life, such as immediate and thorough drying (97%). CONCLUSIONS: We observed high rates of essential newborn care practices including immediate skin-to-skin and delayed cord clamping. We also identified multiple barriers to improving the quality of newborn care in East New Britain, PNG. These findings can inform the development of effective interventions to improve the quality of newborn care. Further, this study demonstrates that multi-faceted programs that include increased investment in the health workforce, education and training, and availability of essential equipment, medicines, and supplies are required to improve newborn outcomes.

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.