Validating the implementation of an indicator reporting policies and laws on free public maternal health-related services in the era of universal health coverage: A multi-country cross-sectional study.

BACKGROUND: The concept of universal health coverage (UHC) encompasses both access to essential health services and freedom from financial harm. The World Health Organization's Maternal Newborn Child and Adolescent Health (MNCAH) Policy Survey collects data on policies that have the potential to reduce maternal morbidity and mortality. The indicator, "Are the following health services provided free of charge at point-of-use in the public sector for women of reproductive age?", captures the free provision of 13 key categories of maternal health-related services, to measure the success of UHC implementation with respect to maternal health. However, it is unknown whether it provides a valid measure of the provision of free care. Therefore, this study compared free maternal healthcare laws and policies against actual practice in three countries. METHODS AND FINDINGS: We conducted a cross-sectional study in four districts/provinces in Argentina, Ghana, and India. We performed desk reviews to identify free care laws and policies at the country level and compared those with reports at the global level. We conducted exit interviews with women aged 15-49 years who used a component service or their accompanying persons, as well as with facility chief financial officers or billing administrators, to determine if women had out-of-pocket expenditures associated with accessing services. For designated free services, prevalence of expenditures at the service level for women and reports by financial officers of women ever having expenditures associated with services designated as free were computed. These three sources of data (desk review, surveys of women and administrators) were triangulated, and chi-square analysis was conducted to determine if charges were levied differentially by standard equity stratifiers. Designation of services as free matched what was reported in the MNCAH Policy Survey for Argentina and Ghana. In India, insecticide-treated bed nets and testing and treatment for syphilis were only designated as free for selected populations, differing from the WHO MNCAH Policy Survey. Among 1046, 923, and 1102 women and accompanying persons who were interviewed in Argentina, Ghana, and India, respectively, the highest prevalence of associated expenditures among women who received a component service in each setting was for cesarean section in Argentina (26%, 24/92); family planning in Ghana (78.4%, 69/88); and postnatal maternal care in India (94.4%, 85/90). The highest prevalence of women ever having out of pocket expenditures associated with accessing any free service reported by financial officers was 9.1% (2/22) in Argentina, 64.1% (93/145) in Ghana, and 29.7% (47/158) in India. Across the three countries, self-reports of out of pocket expenditures were significantly associated with district/province and educational status of women. Additionally, wealth quintile in Argentina and age in India were significantly associated with women reporting out of pocket expenditures. CONCLUSIONS: Free care laws were largely accurately reported in the global MNCAH policy database. Notably, we found that women absorbed both direct and indirect costs and made both formal and informal payments for services designated as free. Therefore, the policy indicator does not provide a valid reflection of UHC in the three settings.

Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial.

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .

Neurodevelopmental assessment of normocephalic children born to Zika virus exposed and unexposed pregnant people.

BACKGROUND: Studies examining the association between in utero Zika virus (ZIKV) exposure and child neurodevelopmental outcomes have produced varied results. METHODS: We aimed to assess neurodevelopmental outcomes among normocephalic children born from pregnant people enrolled in the Zika in Pregnancy in Honduras (ZIPH) cohort study, July-December 2016. Enrollment occurred during the first prenatal visit. Exposure was defined as prenatal ZIKV IgM and/or ZIKV RNA result at enrollment. Normocephalic children, >6 months old, were selected for longitudinal follow-up using the Bayley Scales of Infant and Toddler Development (BSID-III) and the Ages & Stages Questionnaires: Social-Emotional (ASQ:SE-2). RESULTS: One hundred fifty-two children were assessed; after exclusion, 60 were exposed and 72 were unexposed to ZIKV during pregnancy. Twenty children in the exposed group and 21 children in the unexposed group had a composite score <85 in any of the BSID-III domains. Although exposed children had lower cognitive and language scores, differences were not statistically significant. For ASQ:SE-2 assessment, there were not statistically significant differences between groups. CONCLUSIONS: This study found no statistically significant differences in the neurodevelopment of normocephalic children between in utero ZIKV exposed and unexposed. Nevertheless, long-term monitoring of children with in utero ZIKV exposure is warranted. IMPACT: This study found no statistically significant differences in the neurodevelopment in normocephalic children with in utero Zika virus exposure compared to unexposed children, although the exposed group showed lower cognitive and language scores that persisted after adjustment by maternal age and education and after excluding children born preterm and low birth weight from the analysis. Children with prenatal Zika virus exposure, including those normocephalic and have no evidence of abnormalities at birth, should be monitored for neurodevelopmental delays. Follow-up is important to be able to detect developmental abnormalities that might not be detected earlier in life.

Validation of a measure to assess decision-making autonomy in family planning services in three low- and middle-income countries: The Family Planning Autonomous Decision-Making scale (FP-ADM).

BACKGROUND: Integrating measures of respectful care is an important priority in family planning programs, aligned with maternal health efforts. Ensuring women can make autonomous reproductive health decisions is an important indicator of respectful care. While scales have been developed and validated in family planning for dimensions of person-centered care, none focus specifically on decision-making autonomy. The Mothers Autonomy in Decision-Making (MADM) scale measures autonomy in decision-making during maternity care. We adapted the MADM scale to measure autonomy surrounding a woman's decision to use a contraceptive method within the context of contraceptive counselling. This study presents a psychometric validation of the Family Planning Autonomous Decision-Making (FP-ADM) scale using data from Argentina, Ghana, and India. METHODS AND FINDINGS: We used cross-sectional data from women in four subnational areas in Argentina (n = 890), Ghana (n = 1,114), and India (n = 1,130). In each area, 20 primary sampling units (PSUs) were randomly selected based on probability proportional to size. Households were randomly selected in Ghana and India. In Argentina, all facilities providing reproductive and maternal health services within selected PSUs were included and women were randomly selected upon exiting the facility. Interviews were conducted with a sample of 360 women per district. In total, 890 women completed the FP-ADM in Argentina, 1,114 in Ghana and 1,130 in India. To measure autonomous decision-making within FP service delivery, we adapted the items of the MADM scale to focus on family planning. To assess the scale's psychometric properties, we first examined the eigenvalues and conducted a parallel analysis to determine the number of factors. We then conducted exploratory factor analysis to determine which items to retain. The resulting factors were then identified based on the corresponding items. Internal consistency reliability was assessed with Cronbach's alpha. We assessed both convergent and divergent construct validity by examining associations with expected outcomes related to the underlying construct. The Eigenvalues and parallel analysis suggested a two-factor solution. The two underlying dimensions of the construct were identified as "Bidirectional Exchange of Information" (Factor 1) and "Empowered Choice" (Factor 2). Cronbach's alpha was calculated for the full scale and each subscale. Results suggested good internal consistency of the scale. There was a strong, significant positive association between whether a woman expressed satisfaction with quality of care received from the healthcare provider and her FP-ADM score in all three countries and a significant negative association between a woman's FP-ADM score and her stated desire to switch contraceptive methods in the future. CONCLUSIONS: Our results suggest the FP-ADM is a valid instrument to assess decision-making autonomy in contraceptive counseling and service delivery in diverse low- and middle-income countries. The scale evidenced strong construct, convergent, and divergent validity and high internal consistency reliability. Use of the FP-ADM scale could contribute to improved measurement of person-centered family planning services.

"Factors associated with provider unwillingness to perform induced abortion in Argentina: A cross-sectional study in four provinces following the legalization of abortion on request".

BACKGROUND: The 2020 Law on Access to the Voluntary Interruption of Pregnancy is a landmark piece of legislation regarding access to abortion in Argentina. Under the new law, abortion is legal up to 14 weeks and 6 days gestation, with exceptions made to the gestational age limit to save a woman´s life, to preserve a woman´s health, and in case of rape. However, widespread refusal to provide care by authorized health providers (due to conscientious objection or lack of awareness of the new law) could hinder access to legal abortion. This study aimed to assess knowledge of the current legal framework and willingness to perform abortions by authorized professionals in Argentina, to compare perceptions about any requirements necessary to perform abortions on legal grounds between willing and unwilling providers and to explore factors associated with refusal to provide care. METHODS: We conducted a cross-sectional study based on a self-administered, anonymous survey to authorized abortion providers in public health facilities in four provinces of Argentina. FINDINGS: Most authorized providers knew the grounds upon which it is currently legal to perform abortions; however, almost half reported being unwilling to perform abortions, mainly due to conscientious objection. Both willing and unwilling providers believed there were additional requirements not actually stipulated by law. Using logistic regression, we found that province where providers serve, working in a tertiary level facility, and older age were factors associated with unwillingness to provide care. CONCLUSIONS: The results of our study indicate that, even in a favorable legal context, barriers at the provider level may hinder access to abortion in Argentina. They help to demonstrate the need for specific actions that can improve access such as training, further research and public policies that guarantee facilities have sufficient professionals willing to provide abortion care.

Validating indicators for monitoring availability and geographic distribution of emergency obstetric and newborn care (EmoNC) facilities: A study triangulating health system, facility, and geospatial data.

Availability of emergency obstetric and newborn care (EmONC) is a strong supply side measure of essential health system capacity that is closely and causally linked to maternal mortality reduction and fundamentally to achieving universal health coverage. The World Health Organization's indicator "Availability of EmONC facilities" was prioritized as a core indicator to prevent maternal death. The indicator focuses on whether there are sufficient emergency care facilities to meet the population need, but not all facilities designated as providing EmONC function as such. This study seeks to validate "Availability of EmONC" by comparing the value of the indicator after accounting for key aspects of facility functionality and an alternative measure of geographic distribution. This study takes place in four subnational geographic areas in Argentina, Ghana, and India using a census of all birthing facilities. Performance of EmONC in the 90 days prior to data collection was assessed by examining facility records. Data were collected on facility operating hours, staffing, and availability of essential medications. Population estimates were generated using ArcGIS software using WorldPop to estimate the total population, and the number of women of reproductive age (WRA), pregnancies and births in the study areas. In addition, we estimated the population within two-hours travel time of an EmONC facility by incorporating data on terrain from Open Street Map. Using these data sources, we calculated and compared the value of the indicator after incorporating data on facility performance and functionality while varying the reference population used. Further, we compared its value to the proportion of the population within two-hours travel time of an EmONC facility. Included in our study were 34 birthing facilities in Argentina, 51 in Ghana, and 282 in India. Facility performance of basic EmONC (BEmONC) and comprehensive EmONC (CEmONC) signal functions varied considerably. One facility (4.8%) in Ghana and no facility in India designated as BEmONC had performed all seven BEmONC signal functions. In Argentina, three (8.8%) CEmONC-designated facilities performed all nine CEmONC signal functions, all located in Buenos Aires Region V. Four CEmONC-designated facilities in Ghana (57.1%) and the three CEmONC-designated facilities in India (23.1%) evidenced full CEmONC performance. No sub-national study area in Argentina or India reached the target of 5 BEmONC-level facilities per 20,000 births after incorporating facility functionality yet 100% did in Argentina and 50% did in India when considering only facility designation. Demographic differences also accounted for important variation in the indicator's value. In Ghana, the total population in Tolon within 2 hours travel time of a designated EmONC facility was estimated at 99.6%; however, only 91.1% of women of reproductive age were within 2 hours travel time. Comparing the value of the indicator when calculated using different definitions reveals important inconsistencies, resulting in conflicting information about whether the threshold for sufficient coverage is met. This raises important questions related to the indicator's validity. To provide a valid measure of effective coverage of EmONC, the construct for measurement should extend beyond the most narrow definition of availability and account for functionality and geographic accessibility.

Validating midwifery professionals' scope of practice and competency: A multi-country study comparing national data to international standards.

BACKGROUND: There is a global shortage of midwives, whose services are essential to meet the healthcare needs of pregnant women and newborns. Evidence suggests that if enough midwives, trained and regulated to global standards, were deployed worldwide, maternal, and perinatal mortality would decline significantly. Health workforce planning estimates the number of midwives needed to achieve population coverage of midwifery interventions. However, to provide a valid measure of midwifery care coverage, an indicator must consider not only the raw number of midwives, but also their scope and competency. The tasks midwives are authorized to deliver and their competency to perform essential skills and behaviors provide crucial information for understanding the availability of safe, high-quality midwifery services. Without reliable estimates for an adequate midwifery workforce, progress toward ending preventable maternal and perinatal mortality will continue to be uneven. The International Labor Organization (ILO) and the International Confederation of Midwives (ICM) suggest standards for midwifery scope of practice and competencies. This paper compares national midwifery regulations, scope, and competencies in three countries to the ILO and ICM standards to validate measures of midwife density. We also assess midwives' self-reported skills/behaviors from the ICM competencies and their acquisition. METHODS AND FINDINGS: We compared midwives' scope of practice in Argentina, Ghana, and India to the ILO Tasks and ICM Essential Competencies for Midwifery Practice. We compared midwives self-reported skills/behaviors with the ICM Competencies. Univariate and bivariate analysis was conducted to describe the association between midwives' skills and selected characteristics. National scopes of practice matched two ILO tasks in Argentina, four in India, and all in Ghana. National standards partially reflected ICM skills in Categories 2, 3, and 4 (pre-pregnancy and antenatal care; care during labor and birth; and ongoing care of women and newborns, respectively) in Argentina (range 11% to 67%), mostly in India (range 74% to 100%) and completely in Ghana (100% match). 1,266 midwives surveyed reported considerable variation in competency for skills and behaviors across ICM Category 2, 3, and 4. Most midwives reported matching skills and behaviors around labor and childbirth (Category 2). Higher proportions of midwives reported gaining basic skills through in-service training and on-job-experience than in pre-service training. CONCLUSION: Estimating the density of midwives needed for an adequate midwifery workforce capable of providing effective population coverage is predicated on a valid numerator. A reliable and valid count of midwives to meet population needs assumes that each midwife counted has the authority to exercise the same behaviors and reflects the ability to perform them with comparable competency. Our results demonstrate variation in midwifery scopes of practice and self-reported competencies in comparison to global standards that pose a threat to the reliability and validity of the numerator in measures of midwife density, and suggest the potential for expanded authorization and improved education and training to meet global reference standards for midwifery practice has not been fully realized. Although the universally recognized standard, this study demonstrates that the complex, composite descriptions of skills and behaviors in the ICM competencies make them difficult to use as benchmark measures with any precision, as they are not defined or structured to serve as valid measures for assessing workforce competency. A simplified, content-validated measurement system is needed to facilitate evaluation of the competency of the midwifery workforce.

Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis.

BACKGROUND: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. METHODS: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). RESULTS: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons. CONCLUSION: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.

Authorization of midwives to perform basic emergency obstetric and newborn care signal functions in Argentina, Ghana, and India: A multi-country validation study of a key global maternal and newborn health indicator.

BACKGROUND: Midwives' authorization to deliver the seven basic emergency obstetric and newborn care (BEmONC) functions is a core policy indicator in global monitoring frameworks, yet little evidence supports whether such data are captured accurately, or whether authorization demonstrates convergence with midwives' skills and actual provision of services. In this study, we aimed to validate the data reported in global monitoring frameworks (criterion validity) and to determine whether a measure of authorization is a valid indicator for BEmONC availability (construct validity). METHODS: We conducted a validation study in Argentina, Ghana, and India. To assess accuracy of the reported data on midwives' authorization to provide BEmONC services, we reviewed national regulatory documents and compared with reported country-specific data in Countdown to 2030 and the World Health Organization Maternal, Newborn, Child and Adolescent Health Policy Survey. To assess whether authorization demonstrates convergent validity with midwives' skills, training, and performance of BEmONC signal functions, we surveyed 1257 midwives/midwifery professionals and assessed variance. RESULTS: We detected discrepancies between data reported in the global monitoring frameworks and the national regulatory framework in all three countries. We found wide variations between midwives' authorization to perform signal functions and their self-reported skills and actual performance within the past 90 days. The percentage of midwives who reported performing all signal functions for which they were authorized per country-specific regulations was 17% in Argentina, 23% in Ghana, and 31% in India. Additionally, midwives in all three countries reported performing some signal functions that the national regulations did not authorize. CONCLUSION: Our findings suggest limitations in criterion and construct validity for this indicator in Argentina, Ghana, and India. Some signal functions such as assisted vaginal delivery may be obsolete based on current practice patterns. Findings suggest the need to re-examine the emergency interventions that should be included as BEmONC signal functions.

Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS).

BACKGROUND: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews. METHODS: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool. RESULTS: We developed and piloted the "VPASS (Vaccines during Pregnancy - sites supporting Active Safety Surveillance) assessment tool" through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system's purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR). CONCLUSION: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.

Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis.

INTRODUCTION: Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions. METHODS AND ANALYSIS: We aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.

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.

Improving measures of access to legal abortion: A validation study triangulating multiple data sources to assess a global indicator.

BACKGROUND: Global mechanisms have been established to monitor and facilitate state accountability regarding the legal status of abortion. However, there is little evidence describing whether these mechanisms capture accurate data. Moreover, it is uncertain whether the "legal status of abortion" is a valid proxy measure for access to safe abortion, pursuant to the global goals of reducing preventable maternal mortality and advancing reproductive rights. Therefore, this study sought to assess the accuracy of reported monitoring data, and to determine whether evidence supports the consistent application of domestic law by health care professionals such that legality of abortion functions as a valid indicator of access. METHODS AND FINDINGS: We conducted a validation study using three countries as illustrative case examples: Argentina, Ghana, and India. We compared data reported by two global monitoring mechanisms (Countdown to 2030 and the Global Abortion Policies Database) against domestic source documents collected through in-depth policy review. We then surveyed health care professionals authorized to perform abortions about their knowledge of abortion law in their countries and their personal attitudes and practices regarding provision of legal abortion. We compared professionals' responses to the domestic legal frameworks described in the source documents to establish whether professionals consistently applied the law as written. This analysis revealed weaknesses in the criterion validity and construct validity of the "legal status of abortion" indicator. We detected discrepancies between data reported by the global monitoring and accountability mechanisms and the domestic policy reviews, even though all referenced the same source documents. Further, provider surveys unearthed important context-specific barriers to legal abortion not captured by the indicator, including conscientious objection and imposition of restrictions at the provider's discretion. CONCLUSIONS: Taken together, these findings denote weaknesses in the indicator "legal status of abortion" as a proxy for access to safe abortion, as well as inaccuracies in data reported to global monitoring mechanisms. This information provides important groundwork for strengthening indicators for monitoring access to abortion and for renewed advocacy to assure abortion rights worldwide.

Multisite, mixed methods study to validate 10 maternal health system and policy indicators in Argentina, Ghana and India: a research protocol.

INTRODUCTION: Most efforts to assess maternal health indicator validity focus on measures of service coverage. Fewer measures focus on the upstream enabling environment, and such measures are typically not research validated. Thus, methods for validating system and policy-level indicators are not well described. This protocol describes original multicountry research to be conducted in Argentina, Ghana and India, to validate 10 indicators from the monitoring framework for the 'Strategies toward Ending Preventable Maternal Mortality' (EPMM). The overall aim is to improve capacity to drive and track progress towards achieving the priority recommendations in the EPMM strategies. This work is expected to contribute new knowledge on validation methodology and reveal important information about the indicators under study and the phenomena they target for monitoring. Validating the indicators in three diverse settings will explore the external validity of results. METHODS AND ANALYSIS: This observational study explores the validity of 10 indicators from the EPMM monitoring framework via seven discrete validation exercises that will use mixed methods: (1) cross-sectional review of policy data, (2) retrospective review of facility-level patient and administrative data and (3) collection of primary quantitative and qualitative cross-sectional data from health service providers and clients. There is a specific methodological approach and analytic plan for each indicator, directed by unique, relevant validation research questions. ETHICS AND DISSEMINATION: The protocol was approved by the Office of Human Research Administration at Harvard University in November 2019. Individual study sites received approval via local institutional review boards by January 2020 except La Pampa, Argentina, approved June 2020. Our dissemination plan enables unrestricted access and reuse of all published research, including data sets. We expect to publish at least one peer-reviewed publication per validation exercise. We will disseminate results at conferences and engage local stakeholders in dissemination activities in each study country.

Attributes of the food and physical activity built environments from the Southern Cone of Latin America.

Previous studies have shown the influence of the physical and social environments on the development of obesity and non-communicable diseases (NCD). An obesogenic environment promotes higher dietary energy intakes and sedentary behaviors while limiting opportunities or incentives for active living. This paper presents a dataset with key attributes of the food and physical activity built environment, including green spaces, quality of streets and sidewalks, and different types of food retail outlets in four cities of the Southern Cone of Latin America. A total of 139 representative neighborhoods randomly selected from: Marcos Paz and Bariloche (Argentina), Temuco (Chile) and Canelones-Barros Blancos (Uruguay) were evaluated, where standardized community walks were conducted for direct observation of the built environment. This dataset will contribute valuable data to the evaluation of obesogenic environments in the region, and could be linked to additional ecological information about risk factors for NCDs and socio-economic features from other sources. Understanding environmental influences on cardiovascular risk factors and individual habits may help explain NCD outcomes and plan urban policies.

Safety of components and platforms of COVID-19 vaccines considered for use in pregnancy: A rapid review.

BACKGROUND: Rapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed. METHODS: We conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185). RESULTS: We retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns. CONCLUSION: This rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.

COVID-19 and pregnancy: An umbrella review of clinical presentation, vertical transmission, and maternal and perinatal outcomes.

BACKGROUND: We conducted an overview of systematic reviews (SRs) summarizing the best evidence regarding the effect of COVID-19 on maternal and child health following Cochrane methods and PRISMA statement for reporting (PROSPERO-CRD42020208783). METHODS: We searched literature databases and COVID-19 research websites from January to October 2020. We selected relevant SRs reporting adequate search strategy, data synthesis, risk of bias assessment, and/or individual description of included studies describing COVID-19 and pregnancy outcomes. Pair of reviewers independently selected studies through COVIDENCE web-software, performed the data extraction, and assessed its quality through the AMSTAR-2 tool. Discrepancies were resolved by consensus. Each SR's results were synthesized and for the most recent, relevant, comprehensive, and with the highest quality, by predefined criteria, we presented GRADE evidence tables. RESULTS: We included 66 SRs of observational studies out of 608 references retrieved and most (61/66) had "critically low" overall quality. We found a relatively low degree of primary study overlap across SRs. The most frequent COVID-19 clinical findings during pregnancy were fever (28-100%), mild respiratory symptoms (20-79%), raised C-reactive protein (28-96%), lymphopenia (34-80%), and pneumonia signs in diagnostic imaging (7-99%). The most frequent maternal outcomes were C-section (23-96%) and preterm delivery (14-64%). Most of their babies were asymptomatic (16-93%) or presented fever (0-50%), low birth weight (5-43%) or preterm delivery (2-69%). The odds ratio (OR) of receiving invasive ventilation for COVID-19 versus non-COVID-19 pregnant women was 1.88 (95% Confidence Interval [CI] 1.36-2.60) and the OR that their babies were admitted to neonatal intensive care unit was 3.13 (95%CI 2.05-4.78). The risk of congenital transmission or via breast milk was estimated to be low, but close contacts may carry risks. CONCLUSION: This comprehensive overview supports that pregnant women with COVID-19 may be at increased risk of adverse pregnancy and birth outcomes and low risk of congenital transmission.