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.

Towards a better tomorrow: addressing intersectional gender power relations to eradicate inequities in maternal health.

An equity lens to maternal health has typically focused on assessing the differences in coverage and use of healthcare services and critical interventions. While this approach is important, we argue that healthcare experiences, dignity, rights, justice, and well-being are fundamental components of high quality and person-centred maternal healthcare that must also be considered. Looking at differences across one dimension alone does not reflect how fundamental drivers of maternal health inequities-including racism, ethnic or caste-based discrimination, and gendered power relations-operate. In this paper, we describe how using an intersectionality approach to maternal health can illuminate how power and privilege (and conversely oppression and exclusion) intersect and drive inequities. We present an intersectionality-informed analysis on antenatal care quality to illustrate the advantages of this approach, and what is lost in its absence. We reviewed and mapped equity-informed interventions in maternal health to existing literature to identify opportunities for improvement and areas for innovation. The gaps and opportunities identified were then synthesised to propose recommendations on how to apply an intersectionality lens to maternal health research, programmes, and policies.

From global recommendations to (in)action: A scoping review of the coverage of companion of choice for women during labour and birth.

Women greatly value and benefit from the presence of someone they trust to support them throughout labour and childbirth ('labour companion of choice'). Labour companionship improves maternal and perinatal outcomes, including enhancing physiological labour and birth experiences. Despite clear benefits, implementation is slow. We conducted a scoping review to assess coverage and models of labour companionship, including quantitative studies reporting coverage of labour companionship in any level health facility globally. We searched MEDLINE, CINAHL, and Global Health from 1 January 2010-14 December 2021. We extracted data on study design, labour companionship coverage, timing and type of companions allowed, and recoded data into categories for comparison across studies. We included data from a maternal health sentinel network of hospitals in Latin America, using descriptive statistics to assess coverage among 120,581 women giving birth in these sites from April 2018-April 2022. In the scoping review, we included 77 studies from 27 countries. There was wide variation in the coverage of labour companionship: almost one-third of studies reported coverage less than 40%, and one-third of studies reported coverage between 40-80%. Husbands or partners were the most frequent companion (37.7%, 29/77), followed by family member or friend (gender not specified) (32.5%, 25/77), family member or friend (female-only) (13.0%, 10/77). Across nine sentinel hospitals in five Latin American countries, there was variation in coverage, with no companion at any time ranging from 14.9%-93.8%. Despite the well-known benefits and factors affecting implementation of labour companionship, more work is needed to improve equitable coverage. Concerted efforts are needed to engage with communities, health workers, health managers, and policy-makers to establish policies, address implementation barriers, and integrate data on coverage into perinatal records and quality processes to ensure that all women have access. Harmonized reporting of labour companionship would greatly enhance understanding at global level.

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.].

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.

Indonesian midwives' perspectives on changes in the provision of maternity care during the COVID-19 pandemic: A qualitative study.

OBJECTIVE: To explore how COVID-19 influenced the provision of high-quality maternity care in Indonesia. DESIGN AND METHODS: A qualitative descriptive study using in-depth interviews was undertaken. Thematic analysis was used to analyse data, and behaviour change frameworks (Theoretical Domain Framework (TDF) and Capability, Opportunity, and Motivation (COM-B)) were used to identify and map facilitators and barriers influencing maternity care provision during the COVID-19 pandemic. SETTING AND PARTICIPANTS: Fifteen midwives working in community maternity care facilities in Surabaya and Mataram, Indonesia were included. Surabaya is in western Indonesia, with around 56,000 births per year and a population of around 3 million. Mataram is in eastern Indonesia, with around 7,000 births per year and a population of around 500,000. FINDINGS: The main changes to maternity care provision during the COVID-19 pandemic were reduced frequency of antenatal and postpartum care visits, reduced support for women, including unavailability of maternity care and reduced number of antenatal care and labour companions, changes in location of provision of care, and public health changes related to COVID-19. The main factors influencing the provision of high-quality maternity care during the COVID-19 pandemic were behavioural regulation, professional role and identity, and environmental context and resources. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Maternity care provision underwent substantial changes during the COVID-19 pandemic in Indonesia. Findings from this study can contribute to better understanding of how maternity care provision changed during the pandemic, and how positive changes can be reinforced, and negative changes can be addressed.

'We are going into battle without appropriate armour': A qualitative study of Indonesian midwives' experiences in providing maternity care during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has impacted the provision of maternity care worldwide. The continuation of maternity services during the pandemic is vital, but midwives have reported feeling overwhelmed in providing these services at this time. However, there are limited studies in Indonesia that have explored the experiences of midwives in providing care during the pandemic. AIM: Our study aims to explore Indonesian midwives' experiences in providing maternity care during the COVID-19 pandemic. METHODS: We used a descriptive qualitative approach using in-depth interviews to explore the experiences of 15 midwives working in different level of maternity care facilities in two regions in Indonesia, Surabaya and Mataram. All interviews were conducted via WhatsApp call and were audio-recorded with permission. Data were analysed using inductive thematic analysis. FINDINGS: Four themes were identified: 1) fear for the wellbeing of the family and herself, 2) increased workload, 3) motivation and support for midwives, and 4) challenges in providing maternity care for women. DISCUSSION: Sense of duty and loyalty to other midwives motivated midwives to continue working despite their fears and increased workload. Inadequate protection and support and practical challenges faced by midwives should be addressed to ensure midwives' wellbeing and the continuity of maternity care. CONCLUSION: Our study provides insight into Indonesian midwives' experiences in providing maternity care during the COVID-19 pandemic. Adequate protection through PPE availability, effective training and support for midwives' wellbeing is needed to support midwives in providing maternity care during the pandemic. Community's adherence to COVID-19 protocols and good collaboration between primary health centres and hospitals would also benefit midwives.