Dataset Information

Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

ABSTRACT: We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.

SUBMITTER: Smith ER

PROVIDER: S-EPMC9202913 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

Smith Emily R ER Oakley Erin E He Siran S Zavala Rebecca R Ferguson Kacey K Miller Lior L Grandner Gargi Wable GW Abejirinde Ibukun-Oluwa Omolade IO Afshar Yalda Y Ahmadzia Homa H Aldrovandi Grace G Akelo Victor V Tippett Barr Beth A BA Bevilacqua Elisa E Brandt Justin S JS Broutet Natalie N Fernández Buhigas Irene I Carrillo Jorge J Clifton Rebecca R Conry Jeanne J Cosmi Erich E Delgado-López Camille C Divakar Hema H Driscoll Amanda J AJ Favre Guillaume G Flaherman Valerie V Gale Christopher C Gale Christopher C Gil Maria M MM Godwin Christine C Gottlieb Sami S Hernandez Bellolio Olivia O Kara Edna E Khagayi Sammy S Kim Caron Rahn CR Knight Marian M Kotloff Karen K Lanzone Antonio A Le Doare Kirsty K Lees Christoph C Litman Ethan E Lokken Erica M EM Laurita Longo Valentina V Magee Laura A LA Martinez-Portilla Raigam Jafet RJ McClure Elizabeth E Metz Torri D TD Money Deborah D Mullins Edward E Nachega Jean B JB Panchaud Alice A Playle Rebecca R Poon Liona C LC Raiten Daniel D Regan Lesley L Rukundo Gordon G Sanin-Blair Jose J Temmerman Marleen M Thorson Anna A Thwin Soe S Tolosa Jorge E JE Townson Julia J Valencia-Prado Miguel M Visentin Silvia S von Dadelszen Peter P Adams Waldorf Kristina K Whitehead Clare C Yang Huixia H Thorlund Kristian K Tielsch James M JM

PloS one 20220616 6

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the bes ...[more]

PMID: 35709239

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Project description:ObjectiveThis sequential, prospective meta-analysis sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to disease severity, maternal morbidities, neonatal mortality and morbidity, and adverse birth outcomes.Data sourcesWe prospectively invited study investigators to join the sequential, prospective meta-analysis via professional research networks beginning in March 2020.Study eligibility criteriaEligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area.MethodsWe included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a 2-stage meta-analysis.ResultsWe collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (preexisting diabetes mellitus, hypertension, cardiovascular disease) vs those without were at higher risk for COVID-19 severity and adverse pregnancy outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% confidence interval, 1.12-2.71) more likely to be admitted to the intensive care unit. Pregnant women who were underweight before pregnancy were at higher risk of intensive care unit admission (relative risk, 5.53; 95% confidence interval, 2.27-13.44), ventilation (relative risk, 9.36; 95% confidence interval, 3.87-22.63), and pregnancy-related death (relative risk, 14.10; 95% confidence interval, 2.83-70.36). Prepregnancy obesity was also a risk factor for severe COVID-19 outcomes including intensive care unit admission (relative risk, 1.81; 95% confidence interval, 1.26-2.60), ventilation (relative risk, 2.05; 95% confidence interval, 1.20-3.51), any critical care (relative risk, 1.89; 95% confidence interval, 1.28-2.77), and pneumonia (relative risk, 1.66; 95% confidence interval, 1.18-2.33). Anemic pregnant women with COVID-19 also had increased risk of intensive care unit admission (relative risk, 1.63; 95% confidence interval, 1.25-2.11) and death (relative risk, 2.36; 95% confidence interval, 1.15-4.81).ConclusionWe found that pregnant women with comorbidities including diabetes mellitus, hypertension, and cardiovascular disease were at increased risk for severe COVID-19-related outcomes, maternal morbidities, and adverse birth outcomes. We also identified several less commonly known risk factors, including HIV infection, prepregnancy underweight, and anemia. Although pregnant women are already considered a high-risk population, special priority for prevention and treatment should be given to pregnant women with these additional risk factors.

Project description:The current coronavirus disease 2019 (COVID-19) pneumonia pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is spreading globally at an accelerated rate, with a basic reproduction number (R0) of 2-2.5, indicating that 2-3 persons will be infected from an index patient. A serious public health emergency, it is particularly deadly in vulnerable populations and communities in which healthcare providers are insufficiently prepared to manage the infection. As of March 16, 2020, there are more than 180,000 confirmed cases of COVID-19 worldwide, with more than 7000 related deaths. The SARS-CoV-2 virus has been isolated from asymptomatic individuals, and affected patients continue to be infectious 2 weeks after cessation of symptoms. The substantial morbidity and socioeconomic impact have necessitated drastic measures across all continents, including nationwide lockdowns and border closures. Pregnant women and their fetuses represent a high-risk population during infectious disease outbreaks. To date, the outcomes of 55 pregnant women infected with COVID-19 and 46 neonates have been reported in the literature, with no definite evidence of vertical transmission. Physiological and mechanical changes in pregnancy increase susceptibility to infections in general, particularly when the cardiorespiratory system is affected, and encourage rapid progression to respiratory failure in the gravida. Furthermore, the pregnancy bias toward T-helper 2 (Th2) system dominance, which protects the fetus, leaves the mother vulnerable to viral infections, which are more effectively contained by the Th1 system. These unique challenges mandate an integrated approach to pregnancies affected by SARS-CoV-2. Here we present a review of COVID-19 in pregnancy, bringing together the various factors integral to the understanding of pathophysiology and susceptibility, diagnostic challenges with real-time reverse transcription polymerase chain reaction (RT-PCR) assays, therapeutic controversies, intrauterine transmission, and maternal-fetal complications. We discuss the latest options in antiviral therapy and vaccine development, including the novel use of chloroquine in the management of COVID-19. Fetal surveillance, in view of the predisposition to growth restriction and special considerations during labor and delivery, is addressed. In addition, we focus on keeping frontline obstetric care providers safe while continuing to provide essential services. Our clinical service model is built around the principles of workplace segregation, responsible social distancing, containment of cross-infection to healthcare providers, judicious use of personal protective equipment, and telemedicine. Our aim is to share a framework that can be adopted by tertiary maternity units managing pregnant women in the flux of a pandemic while maintaining the safety of the patient and healthcare provider at its core.

Project description:BackgroundSexual dysfunction refers to a chain of psychiatric, individual, and couple's experiences that manifests itself as a dysfunction in sexual desire, sexual arousal, orgasm, and pain during intercourse. The aim of this systematic review will be to assess the sexual dysfunction and determine the relevant factors to sexual dysfunction during pregnancy and postpartum.Methods and analysisAll observational studies, including descriptive, descriptive-analytic, case-control, and cohort studies published between 1990 and 2019, will be included in the study. Review articles, case studies, case reports, letter to editors, pilot studies, and editorial will be excluded from the study. The search will be conducted in the Cochrane Central Register, MEDLINE, Google Scholar, EMBASE, ProQuest, Scopus, WOS, and CINAHL databases. Eligible studies should assess at least one of the sexual dysfunction symptoms in pregnant women or in the first year postpartum. Quality assessment of studies will be performed by two authors independently based on the NOS checklist. This checklist is designed to assess the quality of observational studies. Data will be analyzed using Stata software ver. 11. Considering that the index investigated in the present study will be the level of sexual disorder, standard error will be calculated for each study using binomial distribution. The heterogeneity level will be investigated using Cochran's Q statistic and I2 index in a chi-square test at a significance level of 1.1. Predictable limitations of this study included a small number and unacceptable quality of studies.DiscussionThis systematic review addresses the factors associated with sexual dysfunction during pregnancy and postpartum. Considering the high prevalence of sexual dysfunction among women, the treatment of this problem has been highly sought after by the World Health Organization in recent years. The results of this study can help discover new strategies by introducing factors affecting women's sexual dysfunction, thereby eliminating or diminishing these factors, and play an important role in improving the quality of life of women during pregnancy and postpartum periods.Systematic review registrationPROSPERO CRD42018083554.

Project description:Current evidence from randomized controlled trials (RCTs) and systematic reviews on the utility of convalescent plasma (CP) in patients with coronavirus disease 2019 (COVID-19) suggests a lack of benefit. We conducted an updated meta-analysis of RCTs with trial sequential analysis to investigate whether convalescent plasma is futile in reducing mortality in patients hospitalized with COVID-19. We searched 6 databases from December 1, 2019 to August 1, 2021 for RCTs comparing the use of CP with standard of care or transfusion of non-CP standard plasma in patients with COVID-19. The risk of bias was assessed using the Cochrane Risk-of-Bias 2 Tool. Random effects (DerSimonian and Laird) meta-analyses were conducted. The primary outcome was the aggregate risk for in-hospital mortality between both arms. We conducted a trial sequential analysis (TSA) based on the pooled relative risks (RRs) for in-hospital mortality. Secondary outcomes included the pooled RR for receipt of mechanical ventilation and mean difference in hospital length of stay. We included 18 RCTs (8702 CP, 7906 control). CP was not associated with a significant mortality benefit (RR: 0.95, 95%-CI: 0.86-1.04, P = .27, high certainty). Subgroup analysis did not find any significant differences (pinteraction = 0.30) between patients who received CP within 8 days of symptom onset (RR: 0.97, 95%-CI: 0.79-1.19, P = .80), or after 8 days (RR: 0.79, 95%-CI: 0.57-1.10, P = .16). TSA based on a RR reduction of 10% from a baseline mortality of 20% found that CP was not effective, with the pooled effect within the boundary for futility. CP did not significantly reduce the requirement for mechanical ventilation (RR: 1.00, 95%-CI: 0.91-1.10, P = .99, moderate certainty) or hospital length of stay (+1.32, 95%-CI: -1.86 to +4.52, P = .42, low certainty). CP does not improve relevant clinical outcomes in patients with COVID-19, especially in severe disease. The pooled effect of mortality was within the boundary of futility, suggesting the lack of benefit of CP in patients hospitalized with COVID-19.

Dataset Information

Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

Publications

Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

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