Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial.

BACKGROUND: The World Health Organization (WHO) Labour Care Guide (LCG) is a paper-based labour monitoring tool designed to facilitate the implementation of WHO's latest guidelines for effective, respectful care during labour and childbirth. Implementing the LCG into routine intrapartum care requires a strategy that improves healthcare provider practices during labour and childbirth. Such a strategy might optimize the use of Caesarean section (CS), along with potential benefits on the use of other obstetric interventions, maternal and perinatal health outcomes, and women's experience of care. However, the effects of a strategy to implement the LCG have not been evaluated in a randomised trial. This study aims to: (1) develop and optimise a strategy for implementing the LCG (formative phase); and (2) To evaluate the implementation of the LCG strategy compared with usual care (trial phase). METHODS: In the formative phase, we will co-design the LCG strategy with key stakeholders informed by facility assessments and provider surveys, which will be field tested in one hospital. The LCG strategy includes a LCG training program, ongoing supportive supervision from senior clinical staff, and audit and feedback using the Robson Classification. We will then conduct a stepped-wedge, cluster-randomized pilot trial in four public hospitals in India, to evaluate the effect of the LCG strategy intervention compared to usual care (simplified WHO partograph). The primary outcome is the CS rate in nulliparous women with singleton, term, cephalic pregnancies in spontaneous labour (Robson Group 1). Secondary outcomes include clinical and process of care outcomes, as well as women's experience of care outcomes. We will also conduct a process evaluation during the trial, using standardized facility assessments, in-depth interviews and surveys with providers, audits of completed LCGs, labour ward observations and document reviews. An economic evaluation will consider implementation costs and cost-effectiveness. DISCUSSION: Findings of this trial will guide clinicians, administrators and policymakers on how to effectively implement the LCG, and what (if any) effects the LCG strategy has on process of care, health and experience outcomes. The trial findings will inform the rollout of LCG internationally. TRIAL REGISTRATION: CTRI/2021/01/030695 (Protocol version 1.4, 25 April 2022).

The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women's and newborn's health outcomes, and women's experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries.

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.].

Systematic review on the cost and cost-effectiveness of mHealth interventions supporting women during pregnancy.

OBJECTIVES: The increased integration of digital health into maternity care-alongside growing use of, and access to, personal digital technology among pregnant women-warrants an investigation of the cost-effectiveness of mHealth interventions used by women during pregnancy and the methodological quality of the cost-effectiveness studies. METHODS: A systematic search was conducted to identify peer-reviewed studies published in the last ten years (2011-2021) reporting on the costs or cost-effectiveness of mHealth interventions used by women during pregnancy. Available data related to program costs, total incremental costs and incremental cost-effectiveness ratios (ICERs) were reported in 2020 United States Dollars. The quality of cost-effectiveness studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). FINDINGS: Nine articles reporting on eight studies met the inclusion criteria. Direct intervention costs ranged from $7.04 to $86 per woman, total program costs ranged from $241,341 to $331,136 and total incremental costs ranged from -$21.16 to $1.12 million per woman. The following ICERs were reported: $2168 per DALY averted, $203.44 per woman ceasing smoking, and $3475 per QALY gained. The full economic evaluation studies (n = 4) were moderate to high in quality and all reported the mHealth intervention as cost-effective. Other studies (n = 4) were low to moderate in quality and reported low costs or cost savings associated with the implementation of the mHealth intervention. CONCLUSIONS FOR PRACTICE: Preliminary evidence suggests mHealth interventions may be cost-effective and "low-cost" but more evidence is needed to ascertain the cost-effectiveness of mHealth interventions regarding positive maternal and child health outcomes and longer-term health service utilisation.

Factors affecting the use of antibiotics and antiseptics to prevent maternal infection at birth: A global mixed-methods systematic review.

BACKGROUND: Over 10% of maternal deaths annually are due to sepsis. Prophylactic antibiotics and antiseptic agents are critical interventions to prevent maternal peripartum infections. We conducted a mixed-method systematic review to better understand factors affecting the use of prophylactic antibiotics and antiseptic agents to prevent peripartum infections. METHODS: We searched MEDLINE, EMBASE, Emcare, CINAHL, Global Health, Global Index Medicus, and Maternity and Infant Care for studies published between 1 January 1990 and 27 May 2022. We included primary qualitative, quantitative, and mixed-methods studies that focused on women, families, and healthcare providers' perceptions and experiences of prophylactic antibiotic and antiseptics during labour and birth in health facilities. There were no language restrictions. We used a thematic synthesis approach for qualitative evidence and GRADE-CERQual approach for assessing confidence in these review findings. Quantitative study results were mapped to the qualitative findings and reported narratively. RESULTS: We included 19 studies (5 qualitative, 12 quantitative and 2 mixed-methods studies), 16 relating to antibiotics, 2 to antiseptic use, and 1 study to both antibiotic and antiseptic use. Most related to providers' perspectives and were conducted in high-income countries. Key themes on factors affecting antibiotic use were providers' beliefs about benefits and harms, perceptions of women's risk of infection, regimen preferences and clinical decision-making processes. Studies on antiseptic use explored women's perceptions of vaginal cleansing, and provider's beliefs about benefits and the usefulness of guidelines. CONCLUSION: We identified a range of factors affecting how providers use prophylactic antibiotics at birth, which can undermine implementation of clinical guidelines. There were insufficient data for low-resource settings, women's perspectives, and regarding use of antiseptics, highlighting the need for further research in these areas. Implications for practice include that interventions to improve prophylactic antibiotic use should take account of local environments and perceived infection risk and ensure contextually relevant guidance.

Cost-effectiveness of antenatal corticosteroids and tocolytic agents in the management of preterm birth: A systematic review.

Background: Preterm birth is a leading cause of neonatal mortality and morbidity, and imposes high health and societal costs. Antenatal corticosteroids (ACS) to accelerate fetal lung maturation are commonly used in conjunction with tocolytics for arresting preterm labour in women at risk of imminent preterm birth. Methods: We conducted a systematic review on the cost-effectiveness of ACS and/or tocolytics as part of preterm birth management. We systematically searched MEDLINE and Embase (December 2021), as well as a maternal health economic evidence repository collated from NHS Economic Evaluation Database, EconLit, PubMed, Embase, CINAHL and PsycInfo, with no date cutoff. Eligible studies were economic evaluations of ACS and/or tocolytics for preterm birth. Two reviewers independently screened citations, extracted data on cost-effectiveness and assessed study quality using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Findings: 35 studies were included: 11 studies on ACS, eight on tocolytics to facilitate ACS administration, 12 on acute and maintenance tocolysis, and four studies on a combination of ACS and tocolytics. ACS was cost-effective prior to 34 weeks' gestation, but economic evidence on ACS use at 34-<37 weeks was conflicting. No single tocolytic was identified as the most cost-effective. Studies disagreed on whether ACS and tocolytic in combination were cost-saving when compared to no intervention. Interpretation: ACS use prior to 34 weeks' gestation appears cost-effective. Further studies are required to identify what (if any) tocolytic option is most cost-effective for facilitating ACS administration, and the economic consequences of ACS use in the late preterm period. Funding: UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by WHO.

How do women, men, and health providers perceive interventions to influence men's engagement in maternal and newborn health? A qualitative evidence synthesis.

Globally, there is growing awareness of the important contributions men can make as key stakeholders in maternal and newborn health (MNH), and increased investment in interventions designed to influence men's engagement to improve MNH outcomes. Interventions typically target men, women, couples or health providers, yet how these stakeholders perceive and experience interventions is not well understood and the fact that women may experience these interventions as disempowering has been identified as a major concern. This review aims to synthesise how women, men, and providers perceive and experience interventions designed to influence men's engagement in MNH, in order to identify perceived benefits and risks of participating in interventions, and other key factors affecting uptake of and adherence to interventions. We conducted a qualitative evidence synthesis based on a systematic search of the literature, analysing a purposive sample of 66 out of 144 included studies to enable rich synthesis. Women, men and providers report that interventions enable more and better care for women, newborns and men, and strengthen family relationships between the newborn, father and mother. At the same time, stakeholders report that poorly designed or implemented interventions carry risks of harm, including constraining some women's access to MNH services and compounding negative impacts of existing gender inequalities. Limited health system capacity to deliver men-friendly MNH services, and pervasive gender inequality, can limit the accessibility and acceptability of interventions. Sociodemographic factors, household needs, and peer networks can influence how men choose to support MNH, and may affect demand for and adherence to interventions. Overall, perceived benefits of interventions designed to influence men's engagement in MNH are compelling, reported risks of harm are likely manageable through careful implementation, and there is clear evidence of demand from women and men, and some providers, for increased opportunities and support for men to engage in MNH.

Clinical guidelines for caring for women with COVID-19 during pregnancy, childbirth and the immediate postpartum period.

BACKGROUND: The spread of the novel coronavirus (COVID-19) was declared a pandemic by the World Health Organization on 11th March 2020. Since then there has been a rapid rise in development of maternal and perinatal health guidelines related to COVID-19. The aim of this project was to develop a database of Australian and international recommendations relating to antenatal, intrapartum and postpartum care of women during the COVID-19 pandemic, in order to identify inconsistencies in clinical guidance. METHODS: We conducted weekly web searches from 30th March to 15th May 2020 to identify recommendations pertaining to the care of women during pregnancy, labour and postpartum period from national or international professional societies, specialist colleges, Ministries of Health, Australian state and territory governments, and international guideline development organisations. Individual recommendations were extracted and classified according to intervention type, time period, and patient population. Findings were reported using descriptive analysis, with areas of consensus and non-consensus identified. RESULTS: We identified 81 guidelines from 48 different organisations. Generally, there was high consensus across guidelines for specific interventions. However, variable guidance was identified on the use of nitrous oxide during labour, administration of antenatal corticosteroids, neonatal isolation after birth, labour and birth companions, and the use of disease modifying agents for treating COVID-19. CONCLUSION: Discrepancies between different guideline development organisations creates challenges for maternity care clinicians during the COVID-19 pandemic. Collating recommendations and keeping up-to-date with the latest guidance can help clinicians provide the best possible care to pregnant women and their babies.