Adverse maternal, fetal, and newborn outcomes among pregnant women with SARS-CoV-2 infection: an individual participant data meta-analysis.

INTRODUCTION: Despite a growing body of research on the risks of SARS-CoV-2 infection during pregnancy, there is continued controversy given heterogeneity in the quality and design of published studies. METHODS: We screened ongoing studies in our sequential, prospective meta-analysis. We pooled individual participant data to estimate the absolute and relative risk (RR) of adverse outcomes among pregnant women with SARS-CoV-2 infection, compared with confirmed negative pregnancies. We evaluated the risk of bias using a modified Newcastle-Ottawa Scale. RESULTS: We screened 137 studies and included 12 studies in 12 countries involving 13 136 pregnant women.Pregnant women with SARS-CoV-2 infection-as compared with uninfected pregnant women-were at significantly increased risk of maternal mortality (10 studies; n=1490; RR 7.68, 95% CI 1.70 to 34.61); admission to intensive care unit (8 studies; n=6660; RR 3.81, 95% CI 2.03 to 7.17); receiving mechanical ventilation (7 studies; n=4887; RR 15.23, 95% CI 4.32 to 53.71); receiving any critical care (7 studies; n=4735; RR 5.48, 95% CI 2.57 to 11.72); and being diagnosed with pneumonia (6 studies; n=4573; RR 23.46, 95% CI 3.03 to 181.39) and thromboembolic disease (8 studies; n=5146; RR 5.50, 95% CI 1.12 to 27.12).Neonates born to women with SARS-CoV-2 infection were more likely to be admitted to a neonatal care unit after birth (7 studies; n=7637; RR 1.86, 95% CI 1.12 to 3.08); be born preterm (7 studies; n=6233; RR 1.71, 95% CI 1.28 to 2.29) or moderately preterm (7 studies; n=6071; RR 2.92, 95% CI 1.88 to 4.54); and to be born low birth weight (12 studies; n=11 930; RR 1.19, 95% CI 1.02 to 1.40). Infection was not linked to stillbirth. Studies were generally at low or moderate risk of bias. CONCLUSIONS: This analysis indicates that SARS-CoV-2 infection at any time during pregnancy increases the risk of maternal death, severe maternal morbidities and neonatal morbidity, but not stillbirth or intrauterine growth restriction. As more data become available, we will update these findings per the published protocol.

COVID-19 antibody positivity over time and pregnancy outcomes in seven low-and-middle-income countries: A prospective, observational study of the Global Network for Women's and Children's Health Research.

OBJECTIVES: To determine COVID-19 antibody positivity rates over time and relationships to pregnancy outcomes in low- and middle-income countries (LMICs). DESIGN: With COVID-19 antibody positivity at delivery as the exposure, we performed a prospective, observational cohort study in seven LMICs during the early COVID-19 pandemic. SETTING: The study was conducted among women in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry (MNHR), a prospective, population-based study in Kenya, Zambia, the Democratic Republic of the Congo (DRC), Bangladesh, Pakistan, India (two sites), and Guatemala. POPULATION: Pregnant women enrolled in an ongoing pregnancy registry at study sites. METHODS: From October 2020 to October 2021, standardised COVID-19 antibody testing was performed at delivery among women enrolled in MNHR. Trained staff masked to COVID-19 status obtained pregnancy outcomes, which were then compared with COVID-19 antibody results. MAIN OUTCOME MEASURES: Antibody status, stillbirth, neonatal mortality, maternal mortality and morbidity. RESULTS: At delivery, 26.0% of women were COVID-19 antibody positive. Positivity increased over the four time periods across all sites: 13.8%, 15.4%, 21.0% and 40.9%. In the final period, positivity rates were: DRC 27.0%, Kenya 33.1%, Pakistan 32.8%, Guatemala 37.0%, Zambia 37.8%, Bangladesh 47.2%, Nagpur, India 57.4% and Belagavi, India 62.4%. Adjusting for site and maternal characteristics, stillbirth, neonatal mortality, low birthweight and preterm birth were not significantly associated with COVID-19. The adjusted relative risk (aRR) for stillbirth was 1.27 (95% CI 0.95-1.69). Postpartum haemorrhage was associated with antibody positivity (aRR 1.44; 95% CI 1.01-2.07). CONCLUSIONS: In pregnant populations in LMICs, COVID-19 antibody positivity has increased. However, most adverse pregnancy outcomes were not significantly associated with antibody positivity.

Knowledge, attitudes, and practices of pregnant women regarding COVID-19 vaccination in pregnancy in 7 low- and middle-income countries: An observational trial from the Global Network for Women and Children's Health Research.

OBJECTIVES: We sought to determine the knowledge, attitudes and practices of pregnant women regarding COVID-19 vaccination in pregnancy in seven low- and middle-income countries (LMIC). DESIGN: Prospective, observational, population-based study. SETTINGS: Study areas in seven LMICs: Bangladesh, India, Pakistan, Guatemala, Democratic Republic of the Congo (DRC), Kenya and Zambia. POPULATION: Pregnant women in an ongoing registry. METHODS: COVID-19 vaccine questionnaires were administered to pregnant women in the Global Network's Maternal Newborn Health Registry from February 2021 through November 2021 in face-to-face interviews. MAIN OUTCOME MEASURES: Knowledge, attitude and practice regarding vaccination during pregnancy; vaccination status. RESULTS: No women were vaccinated except for small proportions in India (12.9%) and Guatemala (5.5%). Overall, nearly half the women believed the COVID-19 vaccine is very/somewhat effective and a similar proportion believed that the COVID-19 vaccine is safe for pregnant women. With availability of vaccines, about 56.7% said they would get the vaccine and a 34.8% would refuse. Of those who would not get vaccinated, safety, fear of adverse effects, and lack of trust predicted vaccine refusal. Those with lower educational status were less willing to be vaccinated. Family members and health professionals were the most trusted source of information for vaccination. CONCLUSIONS: This COVID-19 vaccine survey in seven LMICs found that knowledge about the effectiveness and safety of the vaccine was generally low but varied. Concerns about vaccine safety and effectiveness among pregnant women is an important target for educational efforts to increase vaccination rates.

Health care in pregnancy during the COVID-19 pandemic and pregnancy outcomes in six low- and-middle-income countries: Evidence from a prospective, observational registry of the Global Network for Women's and Children's Health.

OBJECTIVE: To assess, on a population basis, the medical care for pregnant women in specific geographic regions of six countries before and during the first year of the coronavirus disease 2019 (COVID-19) pandemic in relationship to pregnancy outcomes. DESIGN: Prospective, population-based study. SETTING: Communities in Kenya, Zambia, the Democratic Republic of the Congo, Pakistan, India and Guatemala. POPULATION: Pregnant women enrolled in the Global Network for Women's and Children's Health's Maternal and Newborn Health Registry. METHODS: Pregnancy/delivery care services and pregnancy outcomes in the pre-COVID-19 time-period (March 2019-February 2020) were compared with the COVID-19 time-period (March 2020-February 2021). MAIN OUTCOME MEASURES: Stillbirth, neonatal mortality, preterm birth, low birthweight and maternal mortality. RESULTS: Across all sites, a small but statistically significant increase in home births occurred between the pre-COVID-19 and COVID-19 periods (18.9% versus 20.3%, adjusted relative risk [aRR] 1.12, 95% CI 1.05-1.19). A small but significant decrease in the mean number of antenatal care visits (from 4.1 to 4.0, p = <0.0001) was seen during the COVID-19 period. Of outcomes evaluated, overall, a small but significant decrease in low-birthweight infants in the COVID-19 period occurred (15.7% versus 14.6%, aRR 0.94, 95% CI 0.89-0.99), but we did not observe any significant differences in other outcomes. There was no change observed in maternal mortality or antenatal haemorrhage overall or at any of the sites. CONCLUSIONS: Small but significant increases in home births and decreases in the antenatal care services were observed during the initial COVID-19 period; however, there was not an increase in the stillbirth, neonatal mortality, maternal mortality, low birthweight, or preterm birth rates during the COVID-19 period compared with the previous year. Further research should help to elucidate the relationship between access to and use of pregnancy-related medical services and birth outcomes over an extended period.

Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccines active safety surveillance in low- and middle-income countries: an international modified Delphi study: [version 1;peer review: 1 approved with reservations]

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.

Minimally Invasive Tissue Sampling Surveillance Alliance-Facilitating the Expansion of Pathology-Based Mortality Surveillance.

The Minimally Invasive Tissue Sampling (MITS) Surveillance Alliance was created with funding from the Bill & Melinda Gates Foundation to expand pathology-based mortality surveillance and to support the generation of improved cause-of-death (CoD) data. MITS, also known as minimally invasive autopsy, has evolved to become an important tool to improve CoD ascertainment. Here, we describe the 18 articles included in this supplement that present advanced methods for improving MITS and related areas of research, summarize the expansion of the use of MITS, report on findings from a variety of research projects, and address the importance of postmortem approaches taken during the novel coronavirus disease 2019 pandemic. Support by the scientific and global health community for enhancements and innovation is needed for the broader adoption of MITS-informed CoD as a critical tool to better understand mortality in low- and middle-income countries and identify interventions for the prevention of premature death.