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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). Plain language summary: 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. [ABSTRACT FROM AUTHOR]

Background: Antenatal care (ANC) services are a prime focus of the Government of India's National Health Mission (NHM), of which a key pillar is the promotion of maternal and child health. To ensure uninterrupted service delivery at the last mile, a cadre of Frontline Health Workers (FLHWs) has been appointed and health centres established at the village level. However, the onset of the COVID-19 pandemic and the nationwide lockdown from late March to June 2020 impacted pregnant women's access to institutional antenatal care services. Methods: Using a qualitative research design, data was collected through 12 in-depth interviews (IDIs) with pregnant women and 17 IDIs with frontline health workers in the selected six districts under study. The narratives were analysed using inductive coding in Atlas.ti. Results: During the first wave of the COVID-19 pandemic, pregnant women, most of whom belonged to poor and marginalised groups, were left with limited access to health centres and FLHWs. Respondents from the study areas of rural Jharkhand, Madhya Pradesh and Uttar Pradesh extensively reported concerns stemming from the lockdown that influenced their decision to access ANC services. These included anxieties around meeting their families' daily needs due to a loss of livelihood (in particular, abject food insecurity), inability to access healthcare, and a sense of mistrust in public health systems and functionaries. All of these, coupled with the real threat to health posed by COVID-19, disrupted their plans for pregnancy and delivery, further compunding the risk to their health and wellbeing. Conclusion: This study identified several social, behavioural and structural facets of the communities that contributed to the confusion, anxiety and helplessness experienced during the COVID-19 first wave by both groups, viz. pregnant women and FLHWs. In planning and implementing initiaves to ensure the delivery and uptake of ANC services in this and similar contexts during times of crisis, these facets must be considered. Plain language summary: This article highlights the status of ANC services during the nationwide lockdown imposed in the first wave of the COVID-19 pandemic in the Indian states of Jharkhand, Madhya Pradesh and Uttar Pradesh. Data was collected through 12 in-depth interviews with pregnant women and 17 in-depth interviews with frontline health workers. Findings suggest that pregnant women were aware of the unprecedented threat of COVID-19 and recommended protective measures through trusted sources of information, including their local Accredited Social Health Activist (ASHA). However, both pregnant women and FLHWs believed that the information they received on the health risks of the pandemic and strategies to address these was inadequate. Temporary suspension of health services in the rural countryside meant that pregnant women could not track the foetus's health status, resulting in confusion and distress. Limited or no interaction with FLHWs, coupled with a reported lack of attention to conditions unrelated to COVID-19 and discrimination at healthcare institutions increased the uncertainty around institutional deliveries. This was further heightened by the loss of livelihoods due to the shutdown of businesses during the lockdown, as the respondents could not turn to private hospitals for childbirth. This resulted in the collapse of the trust of pregnant women and their families in the public healthcare system. To bridge this gap and alleviate the sense of mistrust the pandemic has created in its end-users, strategies to improve the utilisation of health services should respond to the barriers identified in this study. [ABSTRACT FROM AUTHOR]