Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial.

OBJECTIVE: The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali. METHODS: A baseline household survey of Malian women aged 15-49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester. RESULTS: Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business. CONCLUSION: The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context. TRIAL REGISTRATION NUMBER: NCT02694055.

SARS-CoV-2 infection by trimester of pregnancy and adverse perinatal outcomes: a Mexican retrospective cohort study.

OBJECTIVE: Conflicting evidence for the association between COVID-19 and adverse perinatal outcomes exists. This study examined the associations between maternal COVID-19 during pregnancy and adverse perinatal outcomes including preterm birth (PTB), low birth weight (LBW), small-for-gestational age (SGA), large-for-gestational age (LGA) and fetal death; as well as whether the associations differ by trimester of infection. DESIGN AND SETTING: The study used a retrospective Mexican birth cohort from the Instituto Mexicano del Seguro Social (IMSS), Mexico, between January 2020 and November 2021. PARTICIPANTS: We used the social security administrative dataset from IMSS that had COVID-19 information and linked it with the IMSS routine hospitalisation dataset, to identify deliveries in the study period with a test for SARS-CoV-2 during pregnancy. OUTCOME MEASURES: PTB, LBW, SGA, LGA and fetal death. We used targeted maximum likelihood estimators, to quantify associations (risk ratio, RR) and CIs. We fit models for the overall COVID-19 sample, and separately for those with mild or severe disease, and by trimester of infection. Additionally, we investigated potential bias induced by missing non-tested pregnancies. RESULTS: The overall sample comprised 17 340 singleton pregnancies, of which 30% tested positive. We found that those with mild COVID-19 had an RR of 0.89 (95% CI 0.80 to 0.99) for PTB and those with severe COVID-19 had an RR of 1.53 (95% CI 1.07 to 2.19) for LGA. COVID-19 in the first trimester was associated with fetal death, RR=2.36 (95% CI 1.04, 5.36). Results also demonstrate that missing non-tested pregnancies might induce bias in the associations. CONCLUSIONS: In the overall sample, there was no evidence of an association between COVID-19 and adverse perinatal outcomes. However, the findings suggest that severe COVID-19 may increase the risk of some perinatal outcomes, with the first trimester potentially being a high-risk period.

Estimating the effect of realistic improvements of metformin adherence on COVID-19 mortality using targeted machine learning.

Background: Type 2 diabetes elevates the risk of severe outcomes in COVID-19 patients, with multiple studies reporting higher case fatality rates. Metformin is a widely used medication for glycemic management. We hypothesize that improved adherence to metformin may lower COVID-19 post-infection mortality risk in this group. Utilizing data from the Mexican Social Security Institute (IMSS), we investigate the relationship between metformin adherence and mortality following COVID-19 infection in patients with chronic metformin prescriptions. Methods: This is a retrospective cohort study consisting of 61,180 IMSS beneficiaries who received a positive polymerase chain reaction (PCR) or rapid test for SARS-CoV-2 and had at least two consecutive months of metformin prescriptions prior to the positive test. The hypothetical intervention is improved adherence to metformin, measured by proportion of days covered (PDC), with the comparison being the observed metformin adherence values. The primary outcome is all-cause mortality following COVID-19 infection. We defined the causal parameter using shift intervention, an example of modified treatment policies. We used the targeted learning framework for estimation of the target estimand. Findings: Among COVID-19 positive patients with chronic metformin prescriptions, we found that a 5% and 10% absolute increase in metformin adherence is associated with a respective 0.26% (95% CI: -0.28%, 0.79%) and 1.26% (95% CI: 0.72%, 1.80%) absolute decrease in mortality risk. Interpretation: Subject to the limitations of a real-world data study, our results indicate a causal association between improved metformin adherence and reduced COVID-19 post-infection mortality risk.

Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial.

OBJECTIVE: To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation) risk factors for PPH. METHODS: The present study is a secondary analysis of the CHAMPION non-inferiority randomized trial-a two-arm, double-blind, active-controlled study conducted at 23 hospitals in 10 countries, between July 2015 and January 2018. Women with singleton pregnancies, expected to deliver vaginally with cervical dilatation up to 6 cm were eligible. Randomization was stratified by country, with 1:1 assignment. Women in the intervention and control groups received a single intramuscular injection of 100 µg of HSC or 10 IU of oxytocin, respectively. The drugs were administered immediately after birth, and the third stage of labor was managed according to the WHO guidelines. Blood was collected using a plastic drape. For this analysis, we defined a woman as being at risk if she had any one or more of the biologic or pharmacologic risk factor(s). RESULTS: The HSC and oxytocin arms contained 14 770 and 14 768 women, respectively. The risk ratios (RR) for PPH were 1.29 (95% confidence interval [CI] 1.08-1.53) or 1.73 (95% CI 1.51-1.98) for those with only biologic (macrosomia, parity 3 or more, and PPH in the previous pregnancy) or only pharmacologic (induced or augmented) risk factors, respectively, compared with those with neither risk factors. CONCLUSIONS: Findings reinforce previous evidence that macrosomia, high parity, history of PPH, and induction/augmentation are risk factors for PPH. We did not find a difference in effects between HSC and oxytocin for PPH among women who were neither induced nor augmented or among those who were induced or augmented.

Adverse effects of temperature on perinatal and pregnancy outcomes: methodological challenges and knowledge gaps.

Evidence linking temperature with adverse perinatal and pregnancy outcomes is emerging. We searched for literature published until 30 January 2023 in PubMed, Web of Science, and reference lists of articles focusing on the outcomes that were most studied like preterm birth, low birth weight, stillbirth, and hypertensive disorders of pregnancy. A review of the literature reveals important gaps in knowledge and several methodological challenges. One important gap is the lack of knowledge of how core body temperature modulates under extreme ambient temperature exposure during pregnancy. We do not know the magnitude of non-modulation of body temperature during pregnancy that is clinically significant, i.e., when the body starts triggering physiologic counterbalances. Furthermore, few studies are conducted in places where extreme temperature conditions are more frequently encountered, such as in South Asia and sub-Saharan Africa. Little is also known about specific cost-effective interventions that can be implemented in vulnerable communities to reduce adverse outcomes. As the threat of global warming looms large, effective interventions are critically necessary to mitigate its effects.

Defining and estimating effects in cluster randomized trials: A methods comparison.

Across research disciplines, cluster randomized trials (CRTs) are commonly implemented to evaluate interventions delivered to groups of participants, such as communities and clinics. Despite advances in the design and analysis of CRTs, several challenges remain. First, there are many possible ways to specify the causal effect of interest (eg, at the individual-level or at the cluster-level). Second, the theoretical and practical performance of common methods for CRT analysis remain poorly understood. Here, we present a general framework to formally define an array of causal effects in terms of summary measures of counterfactual outcomes. Next, we provide a comprehensive overview of CRT estimators, including the t-test, generalized estimating equations (GEE), augmented-GEE, and targeted maximum likelihood estimation (TMLE). Using finite sample simulations, we illustrate the practical performance of these estimators for different causal effects and when, as commonly occurs, there are limited numbers of clusters of different sizes. Finally, our application to data from the Preterm Birth Initiative (PTBi) study demonstrates the real-world impact of varying cluster sizes and targeting effects at the cluster-level or at the individual-level. Specifically, the relative effect of the PTBi intervention was 0.81 at the cluster-level, corresponding to a 19% reduction in outcome incidence, and was 0.66 at the individual-level, corresponding to a 34% reduction in outcome risk. Given its flexibility to estimate a variety of user-specified effects and ability to adaptively adjust for covariates for precision gains while maintaining Type-I error control, we conclude TMLE is a promising tool for CRT analysis.

Air pollution and child health impacts of decarbonization in 16 global cities: Modelling study.

Most research on the air pollution-related health effects of decarbonization has focused on adults. We assess the potential health benefits that could be achieved in children and young people in a global sample of 16 cities through global decarbonization actions. We modelled annual average concentrations of fine particulate matter (PM2.5) and nitrogen dioxide (NO2) at 1x1 km resolution in the cities using a general circulation/atmospheric chemistry model assuming removal of all global combustion-related emissions from land transport, industries, domestic energy use and power generation. We modelled the impact on childhood asthma incidence and adverse birth outcomes (low birthweight, pre-term births) using published exposure-response relationships. Removal of combustion emissions was estimated to decrease annual average PM2.5 by between 2.9 µg/m3 (8.4%) in Freetown and 45.4 µg/m3 (63.7%) in Dhaka. For NO2, the range was from 0.3 ppb (7.9%) in Freetown to 18.8 ppb (92.3%) in Mexico City. Estimated reductions in asthma incidence ranged from close to zero in Freetown, Tamale and Harare to 149 cases per 100,000 population in Los Angeles. For pre-term birth, modelled impacts ranged from a reduction of 135 per 100,000 births in Dar es Salaam to 2,818 per 100,000 births in Bhubaneswar and, for low birthweight, from 75 per 100,000 births in Dar es Salaam to 2,951 per 100,000 births in Dhaka. The large variations chiefly reflect differences in the magnitudes of air pollution reductions and estimated underlying disease rates. Across the 16 cities, the reduction in childhood asthma incidence represents more than one-fifth of the current burden, and an almost 10% reduction in pre-term and low birthweight births. Decarbonization actions that remove combustion-related emissions contributing to ambient PM2.5 and NO2 would likely lead to substantial but geographically-varied reductions in childhood asthma and adverse birth outcomes, though there are uncertainties in causality and the precision of estimates.

Effect of community health worker home visits on antenatal care and institutional delivery: an analysis of secondary outcomes from a cluster randomised trial in Mali.

INTRODUCTION: Though community health workers (CHWs) have improved access to antenatal care (ANC) and institutional delivery in different settings, it is unclear what package and delivery strategy maximises impact. METHODS: This study reports a secondary aim of the Proactive Community Case Management cluster randomised trial, conducted between December 2016 and April 2020 in Mali. It evaluated whether proactive home visits can improve ANC access at a population level compared with passive site-based care. 137 unique village clusters, covering the entire study area, were stratified by health catchment area and distance to the nearest primary health centre. Within each stratum, clusters were randomly assigned to intervention or control arm. CHWs in intervention clusters proactively visited all homes to provide care. In the control clusters, CHWs provided the same services at their fixed community health post to care-seeking patients. Pregnant women 15-49 years old were enrolled in a series of community-based and facility-based visits. We analysed individual-level annual survey data from baseline and 24-month and 36-month follow-up for the secondary outcomes of ANC and institutional delivery, complemented with CHW monitoring data during the trial period. We compared outcomes between: (1) the intervention and control arms, and (2) the intervention period and baseline. RESULTS: With 2576 and 2536 pregnancies from 66 and 65 clusters in the intervention and control arms, respectively, the estimated risk ratios for receiving any ANC was 1.05 (95% CI 1.02 to 1.07), four or more ANC visits was 1.25 (95% CI 1.08 to 1.43) and ANC initiated in the first trimester was 1.11 (95% CI 1.02 to 1.19), relative to the controls; no differences in institutional delivery were found. However, both arms achieved large improvements in institutional delivery, compared with baseline. Monitoring data show that 19% and 2% of registered pregnancies received at least eight ANC contacts in the intervention and control arms, respectively. Six clusters, three from each arm had to be dropped in the last 2 years of the trial. CONCLUSIONS: Proactive home visits increased ANC and the number of antenatal contacts at the clinic and community levels. ANC and institutional delivery can be increased when provided without fees from professional CHWs in upgraded primary care clinics. TRIAL REGISTRATION NUMBER: NCT02694055.

A comic based interactive digital intervention to enhance facilitation skills of nurse mentors in public facilities - results of a pilot intervention in Bihar, India.

BACKGROUND: Various trainings are designed to educate nurses to become simulation educators. However, there are no good strategies to sustain their learnings and keep them engaged. We developed a series of 10 interactive digital storytelling comic episodes 'The Adventures of Super Divya (SD)' to strengthen simulation educator's facilitation knowledge, skills, confidence, and engagement. This endline evaluation presents results on the change in knowledge after watching the episodes and retention of that knowledge over 10 months. OBJECTIVES: The objectives of this pilot study are to: 1) assess the change in knowledge between the baseline and post-episode surveys; and 2) understand the retention of knowledge between the post-episode and the endline survey. METHODS: A human-centred design was used to create the episodes grounded in the lived experience of nurse simulation educators. The heroine of the comic is Divya, a 'Super Facilitator' and her nemesis is Professor Agni who wants to derail simulation as an educational strategy inside obstetric facilities. Professor Agni's schemes represent real-life challenges; and SD uses effective facilitation and communication to overcome them. The episodes were shared with a group of nurse mentors (NM) and nurse mentor supervisors (NMS) who were trained to be champion simulation educators in their own facilities. To assess change in knowledge, we conducted a baseline, nine post-episode surveys and an endline survey between May 2021 and February 2022. RESULTS: A total 110 NM and 50 NMS watched all 10 episodes and completed all of the surveys. On average, knowledge scores increased by 7-9 percentage points after watching the episodes. Comparison of survey responses obtained between 1 and 10 months suggest that the gain in knowledge was largely retained over time. CONCLUSIONS: Findings suggest that this interactive comic series was successful in a resource limited setting at engaging simulation educators and helped to maintain their facilitation knowledge over time.

Training nurse simulation educators at scale to improve maternal and newborn health: a case study from Bihar, India.

BACKGROUND: Simulation has been shown to improve clinical and behavioral skills of birth attendants in low-resource settings at a low scale. Populous, low-resource settings such as Bihar, India, require large cadres of simulation educators to improve maternal and newborn health. It's unknown if simulation facilitation skills can be adopted through a train of trainers' cascade. To fill this gap, we designed a study to evaluate the simulation and debrief knowledge, attitudes and skills of a third generation of 701 simulation educators in Bihar, India. In addition, we assessed the physical infrastructure where simulation takes place in 40 primary healthcare facilities in Bihar, India. METHODS: We performed a 1 year before-after intervention study to assess the simulation facilitation strengths and weaknesses of a cadre of 701 nurses in Bihar, India. The data included 701 pre-post knowledge and attitudes self-assessments; videos of simulations and associated debriefs conducted by 701 providers at 40 primary healthcare centers. RESULTS: We observed a statistically significant difference in knowledge and attitude scores before and after the 4-day PRONTO simulation educator training. The average number of participants in a simulation video was 5 participants (range 3-8). The average length of simulation videos was 10:21 minutes. The simulation educators under study, covered behavioral in 90% of debriefs and cognitive objectives were discussed in all debriefs. CONCLUSION: This is the first study assessing the simulation and debrief facilitation knowledge and skills of a cadre of 701 nurses in a low-resource setting. Simulation was implemented by local nurses at 353 primary healthcare centers in Bihar, India. Primary healthcare centers have the physical infrastructure to conduct simulation training. Some simulation skills such as communication via whiteboard were widely adopted. Advanced skills such as eliciting constructive feedback without judgment require practice.

Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial.

Background: A large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda. Methods: Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers. Results: Of the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); Pinteraction = 0.025. These trends were similar after excluding the PTBi primary cohort. Conclusions: The intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries. Registration: This trial is registered with ClinicalTrials.gov, NCT03112018.

Stillbirth, neonatal and maternal mortality among caesarean births in Kenya and Uganda: a register-based prospective cohort study.

OBJECTIVE: To investigate the interaction of risks for adverse maternal and perinatal outcomes (stillbirth, predischarge neonatal and maternal mortality) among caesarean section (CS) compared with vaginal deliveries (VD). DESIGN: Prospective cohort study. SETTING: 10 CS-capable facilities in Busoga Region, East-Central Uganda and Migori County, Kenya. PARTICIPANTS: Individual birth data were extracted from maternity registers between October 2016 and April 2019. There were a total of 77 242 livebirths and 3734 stillbirths. Overall, 24% of deliveries were by CS with a range of 9%-49% across facilities. PRIMARY OUTCOME MEASURES: Stillbirth, predischarge neonatal mortality and maternal mortality. RESULTS: The adjusted ORs for stillbirth, predischarge neonatal mortality and maternal mortality after a CS were 1.3 (95% CI 1.1 to 1.6), 1.9 (95% CI 1.6 to 2.2) and 3.3 (95% CI 2.2 to 4.9), respectively, compared with a VD. The association between maternal mortality and CS was 3.9 (95% CI 2.8 to 5.5) when the delivery was a live birth and 1.7 (95% CI 1.0 to 3.0) when it was a stillbirth. Post hoc analyses showed that mothers who received a CS had a lower risk of stillbirth if they were documented as a referral. CONCLUSION: In this context, CS births were at higher risk for worse outcomes compared with VD. Better understanding of CS use and associated adverse outcomes within the mother-baby dyad is necessary to identify opportunities to improve quality of intrapartum care. TRIAL REGISTRATION NUMBER: NCT03112018.

Super Divya, an Interactive Digital Storytelling Instructional Comic Series to Sustain Facilitation Skills of Labor and Delivery Nurse Mentors in Bihar, India-A Pilot Study.

To improve the quality of intrapartum care in public health facilities of Bihar, India, a statewide quality improvement program was implemented. Nurses participated in simulation sessions to improve their clinical, teamwork, and communication skills. Nurse mentors, tasked with facilitating these sessions, received training in best practices. To support the mentors in the on-going facilitation of these trainings, we developed a digital, interactive, comic series starring "Super Divya", a simulation facilitation superhero. The objective of these modules was to reinforce key concepts of simulation facilitation in a less formal and more engaging way than traditional didactic lessons. This virtual platform offers the flexibility to watch modules frequently and at preferred times. This pilot study involved 205 simulation educators who were sent one module at a time. Shortly before sending the first module, nurses completed a baseline knowledge survey, followed by brief surveys after each module to assess change in knowledge. Significant improvements in knowledge were observed across individual scores from baseline to post-survey. A majority found Super Divya modules to be acceptable and feasible to use as a learning tool. However, a few abstract concepts in the modules were not well-understood, suggesting that more needs to be done to communicate their core meaning of these concepts.

Super Divya to the rescue! Exploring Nurse Mentor Supervisor perceptions on a digital tool to support learning and engagement for simulation educators in Bihar, India.

BACKGROUND: Since 2014, the Government of Bihar and CARE India have implemented a nurse mentoring program that utilizes PRONTO International's simulation and team trainings to improve obstetric and neonatal care. Together they trained simulation educators known as Nurse Mentor Supervisors to conduct simulation trainings in rural health facilities across the state. Sustaining the knowledge and engagement of these simulation educators at a large-scale has proven difficult and resource intensive. To address this, the University of Utah with PRONTO International and with input from the University of California San Francisco, created an interactive, virtual education module based on a comic superhero named Super Divya to reinforce simulation educator concepts. This study examined the perceptions of Nurse Mentor Supervisors on Super Divya's accessibility, usefulness, and potential after implementation of Super Divya: Origin Story. METHODS: We conducted qualitative interviews with 17 Nurse Mentor Supervisors in Bihar, India. In light of the COVID-19 pandemic, interviews were conducted virtually via Zoom™ using a semi-structured interview guide in Hindi and English. Participants were identified with strict inclusion criteria and convenience sampling methods. Interviews were analyzed using a framework analysis. RESULTS: Nurse Mentor Supervisors found Super Divya to be engaging, innovative, relatable, and useful in teaching tips and tricks for simulation training. Supervisors thought the platform was largely accessible with some concerns around internet connectivity and devices. The majority reacted positively to the idea of distributing Super Divya to other simulation educators in the nurse mentoring program and had suggestions for additional clinical and simulation educator training topics. CONCLUSIONS: This study demonstrates the potential of Super Divya to engage simulation educators in continuous education. At a time when virtual education is increasingly important and in-person training was halted by the COVID-19 pandemic, Super Divya engaged Supervisors in the nurse mentoring program. We have incorporated suggestions for improvement of Super Divya into future modules. Further research can help understand how knowledge from Super Divya can improve simulation facilitation skills and behaviors, and explore potential for reinforcing clinical skills via this platform. ETHICAL APPROVAL: This study was approved by the institutional review board at the University of California San Francisco (IRB # 20-29902).

Simulation and nurse-mentoring in a statewide nurse mentoring program in Bihar, India: diagnosis of postpartum hemorrhage and intrapartum asphyxia.

Background: Mentoring programs that include simulation, bedside mentoring, and didactic components are becoming increasingly popular to improve quality. These programs are designed with little evidence to inform the optimal composition of mentoring activities that would yield the greatest impact on provider skills and patient outcomes. We examined the association of number of maternal and neonatal emergency simulations performed with the diagnosis of postpartum hemorrhage (PPH) and intrapartum asphyxia in real patients. Methods: We used a prospective cohort and births were compared between- and within-facility over time. Setting included 320 public facilities in the state of Bihar, India May 2015 - 2017. The participants were deliveries and livebirths. The interventions carried out were mobile nurse-mentoring program with simulations, teamwork and communication activities, didactic teaching, demonstrations of clinical procedures and bedside mentoring including conducting deliveries. Nurse mentor pairs visited each facility for one week, covering four facilities over a four-week period, for seven to nine consecutive months. The outcome measures were diagnosis of PPH and intrapartum asphyxia. Results:Relative to the bottom one-third facilities that performed the fewest maternal simulations, facilities in the middle one-third group diagnosed 26% (incidence rate ratio [IRR] = 1.26, 95% confidence interval [CI]: 1.00, 1.59) more cases of PPH in real patients. Similarly, facilities in the middle one-third group, diagnosed 25% (IRR = 1.25, 95% CI: 1.04, 1.50) more cases of intrapartum asphyxia relative to the bottom third group that did the fewest neonatal simulations. Facilities in the top one-third group (i.e., performed the most simulations) did not have a significant difference in diagnosis of both outcomes, relative to the bottom one-third group. Results:Relative to the bottom one-third facilities that performed the fewest maternal simulations, facilities in the middle one-third group diagnosed 26% (incidence rate ratio [IRR] = 1.26, 95% confidence interval [CI]: 1.00, 1.59) more cases of PPH in real patients. Similarly, facilities in the middle one-third group, diagnosed 25% (IRR = 1.25, 95% CI: 1.04, 1.50) more cases of intrapartum asphyxia relative to the bottom third group that did the fewest neonatal simulations. Facilities in the top one-third group (i.e., performed the most simulations) did not have a significant difference in diagnosis of both outcomes, relative to the bottom one-third group. Conclusions: Findings suggest a complex relationship between performing simulations and opportunities for direct practice with patients, and there may be an optimal balance in performing the two that would maximize diagnosis of PPH and intrapartum asphyxia.

Correction: Ambient and household PM2.5 pollution and adverse perinatal outcomes: A meta-regression and analysis of attributable global burden for 204 countries and territories.

[This corrects the article DOI: 10.1371/journal.pmed.1003718.].

Ambient and household PM2.5 pollution and adverse perinatal outcomes: A meta-regression and analysis of attributable global burden for 204 countries and territories.

BACKGROUND: Particulate matter <2.5 micrometer (PM2.5) is associated with adverse perinatal outcomes, but the impact on disease burden mediated by this pathway has not previously been included in the Global Burden of Disease (GBD), Mortality, Injuries, and Risk Factors studies. We estimated the global burden of low birth weight (LBW) and preterm birth (PTB) and impacts on reduced birth weight and gestational age (GA), attributable to ambient and household PM2.5 pollution in 2019. METHODS AND FINDINGS: We searched PubMed, Embase, and Web of Science for peer-reviewed articles in English. Study quality was assessed using 2 tools: (1) Agency for Healthcare Research and Quality checklist; and (2) National Institute of Environmental Health Sciences (NIEHS) risk of bias questions. We conducted a meta-regression (MR) to quantify the risk of PM2.5 on birth weight and GA. The MR, based on a systematic review (SR) of articles published through April 4, 2021, and resulting uncertainty intervals (UIs) accounted for unexplained between-study heterogeneity. Separate nonlinear relationships relating exposure to risk were generated for each outcome and applied in the burden estimation. The MR included 44, 40, and 40 birth weight, LBW, and PTB studies, respectively. Majority of the studies were of retrospective cohort design and primarily from North America, Europe, and Australia. A few recent studies were from China, India, sub-Saharan Africa, and South America. Pooled estimates indicated 22 grams (95% UI: 12, 32) lower birth weight, 11% greater risk of LBW (1.11, 95% UI: 1.07, 1.16), and 12% greater risk of PTB (1.12, 95% UI: 1.06, 1.19), per 10 µg/m3 increment in ambient PM2.5. We estimated a global population-weighted mean lowering of 89 grams (95% UI: 88, 89) of birth weight and 3.4 weeks (95% UI: 3.4, 3.4) of GA in 2019, attributable to total PM2.5. Globally, an estimated 15.6% (95% UI: 15.6, 15.7) of all LBW and 35.7% (95% UI: 35.6, 35.9) of all PTB infants were attributable to total PM2.5, equivalent to 2,761,720 (95% UI: 2,746,713 to 2,776,722) and 5,870,103 (95% UI: 5,848,046 to 5,892,166) infants in 2019, respectively. About one-third of the total PM2.5 burden for LBW and PTB could be attributable to ambient exposure, with household air pollution (HAP) dominating in low-income countries. The findings should be viewed in light of some limitations such as heterogeneity between studies including size, exposure levels, exposure assessment method, and adjustment for confounding. Furthermore, studies did not separate the direct effect of PM2.5 on birth weight from that mediated through GA. As a consequence, the pooled risk estimates in the MR and likewise the global burden may have been underestimated. CONCLUSIONS: Ambient and household PM2.5 were associated with reduced birth weight and GA, which are, in turn, associated with neonatal and infant mortality, particularly in low- and middle-income countries.

Increases in diagnosis and management of obstetric and neonatal complications in district hospitals during a high intensity nurse-mentoring program in Bihar, India.

Maternal and neonatal mortality in Bihar, India was far higher than the aspirational levels set out by the Sustainable Development Goals. Provider training programs have been implemented in many low-resource settings to improve obstetric and neonatal outcomes. This longitudinal investigation assessed diagnoses and management of postpartum hemorrhage (PPH), hypertensive disorders of pregnancy, birth asphyxia (BA), and low birth weight (LBW), as part of the CARE's AMANAT program in 22 District Hospitals in Bihar, between 2015 and 2017. Physicians and nurse mentors conducted clinical instruction, simulations and teamwork and communication activities, infrastructure and management support, and data collection for 6 consecutive months. Analysis of diagnosis included 11,259 non-referred and management included 11,800 total (non-referred and referred) admissions that were observed. Data were analyzed using the chi-square test for trend. PPH was diagnosed in 3.7% with no significant trend but diagnosis of hypertensive disorders increased from 1.0% to 1.7%, (ptrend = 0.04), over the 6 months. BA was diagnosed in 5.8% with no significant trend but LBW diagnoses increased from 11% to 16% (ptrend<0.01). Among PPH patients, 96% received fluids, 85% received uterotonics and 11% received Tranexamic Acid (TXA). There was a significant positive trend in the number of patients receiving TXA for PPH (6% to 13.8%, ptrend = 0.03). Of all neonates with BA, there were statistically significant increases in the proportion who were initially warmed, dried, and stimulated (78% to 94%, ptrend = 0.02), received airway suction (80% to 93%, ptrend = 0.03), and supplemental oxygen without positive pressure ventilation (73% to 86%, ptrend = 0.05). Diagnoses of hypertensive disorders and LBW as well as initial management of BA increased during the AMANAT program. However, underdiagnoses of PPH and hypertensive disorders relative to population levels remain critical barriers to improving maternal morbidity and mortality.

Assessing the impact of group antenatal care on gestational length in Rwanda: A cluster-randomized trial.

BACKGROUND: Research on group antenatal care in low- and middle-income contexts suggests high acceptability and preliminary implementation success. METHODS: We studied the effect of group antenatal care on gestational age at birth among women in Rwanda, hypothesizing that participation would increase mean gestational length. For this unblinded cluster randomized trial, 36 health centers were pair-matched and randomized; half continued individual antenatal care (control), half implemented group antenatal care (intervention). Women who initiated antenatal care between May 2017 and December 2018 were invited to participate, and included in analyses if they presented before 24 weeks gestation, attended at least two visits, and their birth outcome was obtained. We used a generalized estimating equations model for analysis. FINDINGS: In total, 4091 women in 18 control clusters and 4752 women in 18 intervention clusters were included in the analysis. On average, women attended three total antenatal care visits. Gestational length was equivalent in the intervention and control groups (39.3 weeks (SD 1.6) and 39.3 weeks (SD 1.5)). There were no significant differences between groups in secondary outcomes except that more women in control sites attended postnatal care visits (40.1% versus 29.7%, p = 0.003) and more women in intervention sites attended at least three total antenatal care visits (80.7% versus 71.7%, p = 0.003). No harms were observed. INTERPRETATION: Group antenatal care did not result in a difference in gestational length between groups. This may be due to the low intervention dose. We suggest studies of both the effectiveness and costs of higher doses of group antenatal care among women at higher risk of preterm birth. We observed threats to group care due to facility staff shortages; we recommend studies in which antenatal care providers are exclusively allocated to group antenatal care during visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT03154177.

Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial.

BACKGROUND: Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised. METHODS: This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov, NCT03112018. FINDINGS: Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54-0·81). No harm or adverse effects were found. INTERPRETATION: Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening. FUNDING: Bill & Melinda Gates Foundation.