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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]

Objectives: Ethical dilemmas at both the individual and structural level are part of the daily work of midwives and gender inequality and injustice can affect women's sexual and reproductive health. Mainstream bioethical theory has been criticized for neglecting women's issues. To ensure women's experiences are addressed, a gender lens on ethics is crucial. Aim: This study develops a theory model by exploring ethical dilemmas related to gender in the context of maternity care from the perspective of midwifery science and feminist ethics. Methods: The research strategy followed a coherent stepwise approach: literature search, thematic analysis, elaboration of a gender ethics protocol, and the integration of various components into a preliminary gender ethics model for midwifery. Findings: A literature search was performed using Scopus and Web of Science to identify ethical dilemmas in maternity care linked to gender and power. The search of articles published between 1996 and 2019 returned 61 abstracts. These abstracts were screened and assigned one of the following themes: The Midwifery Profession, The Rights of the Woman, Fetal Rights Dominate, and Medicalization of Pregnancy and Childbirth. A tentative gender ethics frame was developed and tested on two articles on abortion, one from Denmark and one from Japan. The protocol facilitated the gender analysis of ethical dilemmas related to abortion, which were related to the imbalance of power relations in health care. In the final step, we synthesized the dimensions of gender and power in a gender ethics model for midwifery. Discussion: The gender ethics protocol developed revealed gendered dimensions of ethical dilemmas in midwifery. This gender analysis adds to the understanding of the "do no harm" principle by revealing assumptions and stereotypes that promote unequal power relations. The gender ethics model is an innovative approach that envisions and exposes power imbalance at the micro, meso, and macro levels. Conclusions: The protocol could improve gender competence among researchers, midwives/professionals, and midwifery students throughout the world. Plain Language summary: As gender inequity, gender inequality, and oppression infuse dimensions in all human cultures and societies, not the least in midwifery practice where the layers of injustice affect women during pregnancy and birth in high-, middle-, and low-income countries, the time has come to renew the perspectives of normative ethics. In this study, we explore gender ethical dilemmas unique to maternity care from the perspective of midwifery science and feminist ethics. A literature search uncovered ethical dilemmas in midwifery, and four broad themes were identified: Midwifery Profession, Rights of the Woman, Fetal Rights Dominate, and Medicalization of Pregnancy and Childbirth. Next, we developed a gender ethics protocol suitable for providing gender ethical interpretations of results. The protocol was tested and refined using two articles (one from the Denmark and one from Japan) that address ethical dilemmas of abortion care. The pilot analysis indicates that the autonomy of midwives and their scope of practice might be constrained and that the obstetric medicalized/authoritative knowledge still plays a dominate role in maternity practice. Here, we present an elaborate model, gender ethics model for midwifery (GEMM), developed for midwifery science that can be further refined. The model challenges the views of maternity care and contributes to a deeper understanding of how fluid concepts such as gender and power circulate and influence women's and birthing person's sexual and reproductive health. Statement of significance: Problem or issue Layers of injustice affect women during pregnancy and birth in both high-, middle-, and low-income countries. The time has come to renew the perspectives of normative ethics. What is already known? Globally, ethical dilemmas at both the individual and structural levels pervade the daily work of midwives, but ethical research that includes gender theory in midwifery science is limited. What this paper adds Here, we present a gender ethics protocol and develop an innovative gender theory ethics model for midwifery to improve gender competence among researchers, midwives/professionals, and midwifery students. [ABSTRACT FROM AUTHOR]