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

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

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

A survey evaluating practice pattern in management of obstetric hemorrhage

BACKGROUND: Hemorrhage anticipation and management has shifted significantly over the past decade due to evolution of data surrounding management of obstetric hemorrhage. Limited data exists which describe the practical use and clinical application of hemorrhage management. Our goal was to identify obstetric hemorrhage management patterns in a cohort of practicing Maternal Fetal Medicine physicians. METHODS: We administered a survey to Maternal Fetal Medicine (MFM) fellows and faculty that addressed the management of hemorrhage including risk assessment, uterotonic use, antifibrinolytic use, cell saver use, and abnormal placentation management. An email was sent out regarding the survey to a listserv of all Maternal Fetal Medicine fellow program coordinators to disseminate to their faculty and fellows. Eighty responses were obtained. RESULTS: A total of 78 surveys were analyzed. Participants preferred methylergonovine as a first line agent (n = 57; 73%, n = 62; 80%). Most participants would consider using cell salvage when also activating MTP (28, 48%) or during scheduled deliveries who are high risk of hemorrhage (40, 69%). Approximately a third of providers would use TXA (tranexamic acid) prophylactically (n = 21; 28%). Only 26% of MFM fellows felt comfortable performing cesarean hysterectomy without Gynecologic Oncology. CONCLUSION: In comparison to prior reports, TXA use has increased substantially. Further, when looking at the management of abnormal placentation, the use of magnetic resonance imaging and embolization have both increased. Possibly due to the rise in centers of excellence for treatment of accreta spectrum disorders, Maternal Fetal Medicine fellows still feel largely unprepared to perform a cesarean hysterectomy without Gynecologic Oncology

Disparities in obstetric hemorrhage outcomes

Both the maternal and fetal outcomes of pregnancy vary greatly according to a pregnant woman\u27s community and her condition. The most devastating outcome is the death of a mother. In 2017, there were ≈295,000 maternal deaths globally with dramatic differences in maternal mortality based on geographic region, country, and women\u27s underlying conditions. Worldwide, the leading cause of maternal death is hemorrhage, comprising 94% of maternal deaths, with most cases occurring in low- or middle-income countries. Whether a hemorrhage originates from inside the uterus (80%-90%), from lacerations or incisions (10%-20%), or from an underlying coagulopathy (\u3c1%), an acute acquired coagulopathy will evolve unless the hemorrhage is controlled. In low- or middle-income countries, the full range of resources to control hemorrhage is not available, but besides the usual obstetric measures, blood availability, hemostatic medication, and hematologic expertise are necessary to save mothers\u27 lives. Hemostasis and thrombosis experts can address the disparities in obstetric hemorrhage outcomes not only as providers but as consultants, researchers, and advocates

Tranexamic Acid for Prevention and Treatment of Postpartum Hemorrhage: An Update on Management and Clinical Outcomes.

© 2018 Wolters Kluwer Health, Inc. All rights reserved. Importance: Postpartum hemorrhage (PPH) remains amajor cause ofmaternalmortality worldwide, occurring in both vaginal and cesarean deliveries.We have witnessed improvements in both prevention and treatment of PPH. Tranexamic acid (TXA) has been investigated as a potential adjunct therapy to uterotonics within this setting. Objective: The aim of this article is to summarize existing recommendations on the use of TXA in obstetrics and review current data on clinical outcomes after TXA use. Evidence Acquisition: We reviewed guidelines from a number of professional societies and performed an extensive literature search reviewing relevant and current data in this area. Results and Conclusions: In the prevention of PPH, TXA use before both vaginal and cesarean deliveries reduces the amount of postpartum blood loss and should be considered in patients at higher risk for hemorrhage. In the treatment of PPH, TXA should be initiated early for maximal survival benefit from hemorrhage, and it provides no additional benefit if administered more than 3 hours from delivery. Overall, current evidence assessing the risks of TXA use in an obstetric population is reassuring. Target Audience: Obstetricians and gynecologists, family physicians. Learning Objectives: After completing this activity, the learner should be better able to: define themechanism of action of TXA; evaluate the utility of TXA in prophylaxis and treatment of PPH; define common doses of TXA used in the peripartum period; and assess associated risk and possible adverse outcome when using TXA

Tranexamic Acid for Prevention and Treatment of Postpartum Hemorrhage: An Update on Management and Clinical Outcomes

© 2018 Wolters Kluwer Health, Inc. All rights reserved. Importance: Postpartum hemorrhage (PPH) remains amajor cause ofmaternalmortality worldwide, occurring in both vaginal and cesarean deliveries.We have witnessed improvements in both prevention and treatment of PPH. Tranexamic acid (TXA) has been investigated as a potential adjunct therapy to uterotonics within this setting. Objective: The aim of this article is to summarize existing recommendations on the use of TXA in obstetrics and review current data on clinical outcomes after TXA use. Evidence Acquisition: We reviewed guidelines from a number of professional societies and performed an extensive literature search reviewing relevant and current data in this area. Results and Conclusions: In the prevention of PPH, TXA use before both vaginal and cesarean deliveries reduces the amount of postpartum blood loss and should be considered in patients at higher risk for hemorrhage. In the treatment of PPH, TXA should be initiated early for maximal survival benefit from hemorrhage, and it provides no additional benefit if administered more than 3 hours from delivery. Overall, current evidence assessing the risks of TXA use in an obstetric population is reassuring. Target Audience: Obstetricians and gynecologists, family physicians. Learning Objectives: After completing this activity, the learner should be better able to: define themechanism of action of TXA; evaluate the utility of TXA in prophylaxis and treatment of PPH; define common doses of TXA used in the peripartum period; and assess associated risk and possible adverse outcome when using TXA

Correction: Predicting peripartum blood transfusion in women undergoing cesarean delivery: A risk prediction model.

[This corrects the article DOI: 10.1371/journal.pone.0208417.]