Objective To determine the clinical manifestations, risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed coronavirus disease 2019 (covid-19). Design Living systematic review and meta-analysis. Data sources Medline, Embase, Cochrane database, WHO COVID-19 database, China National Knowledge Infrastructure (CNKI), and Wanfang databases from 1 December 2019 to 6 October 2020, along with preprint servers, social media, and reference lists. Study selection Cohort studies reporting the rates, clinical manifestations (symptoms, laboratory and radiological findings), risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed covid-19. Data extraction At least two researchers independently extracted the data and assessed study quality. Random effects meta-analysis was performed, with estimates pooled as odds ratios and proportions with 95% confidence intervals. All analyses will be updated regularly. Results 192 studies were included. Overall, 10% (95% confidence interval 7% to 12%; 73 studies, 67 271 women) of pregnant and recently pregnant women attending or admitted to hospital for any reason were diagnosed as having suspected or confirmed covid-19. The most common clinical manifestations of covid-19 in pregnancy were fever (40%) and cough (41%). Compared with non-pregnant women of reproductive age, pregnant and recently pregnant women with covid-19 were less likely to have symptoms (odds ratio 0.28, 95% confidence interval 0.13 to 0.62; I2=42.9%) or report symptoms of fever (0.49, 0.38 to 0.63; I2=40.8%), dyspnoea (0.76, 0.67 to 0.85; I2=4.4%) and myalgia (0.53, 0.36 to 0.78; I2=59.4%). The odds of admission to an intensive care unit (odds ratio 2.13, 1.53 to 2.95; I2=71.2%), invasive ventilation (2.59, 2.28 to 2.94; I2=0%) and need for extra corporeal membrane oxygenation (2.02, 1.22 to 3.34; I2=0%) were higher in pregnant and recently pregnant than non-pregnant reproductive aged women. Overall, 339 pregnant women (0.02%, 59 studies, 41 664 women) with confirmed covid-19 died from any cause. Increased maternal age (odds ratio 1.83, 1.27 to 2.63; I2=43.4%), high body mass index (2.37, 1.83 to 3.07; I2=0%), any pre-existing maternal comorbidity (1.81, 1.49 to 2.20; I2=0%), chronic hypertension (2.0, 1.14 to 3.48; I2=0%), pre-existing diabetes (2.12, 1.62 to 2.78; I2=0%), and pre-eclampsia (4.21, 1.27 to 14.0; I2=0%) were associated with severe covid-19 in pregnancy. In pregnant women with covid-19, increased maternal age, high body mass index, non-white ethnicity, any pre-existing maternal comorbidity including chronic hypertension and diabetes, and pre-eclampsia were associated with serious complications such as admission to an intensive care unit, invasive ventilation and maternal death. Compared to pregnant women without covid-19, those with the disease had increased odds of maternal death (odds ratio 2.85, 1.08 to 7.52; I2=0%), of needing admission to the intensive care unit (18.58, 7.53 to 45.82; I2=0%), and of preterm birth (1.47, 1.14 to 1.91; I2=18.6%). The odds of admission to the neonatal intensive care unit (4.89, 1.87 to 12.81, I2=96.2%) were higher in babies born to mothers with covid-19 versus those without covid-19. Conclusion Pregnant and recently pregnant women with covid-19 attending or admitted to the hospitals for any reason are less likely to manifest symptoms such as fever, dyspnoea, and myalgia, and are more likely to be admitted to the intensive care unit or needing invasive ventilation than non-pregnant women of reproductive age. Pre-existing comorbidities, non-white ethnicity, chronic hypertension, pre-existing diabetes, high maternal age, and high body mass index are risk factors for severe covid-19 in pregnancy. Pregnant women with covid-19 versus without covid-19 are more likely to deliver preterm and could have an increased risk of maternal death and of being admitted to the intensive care unit. Their babies are more likely to be admitted to the neonatal unit. Systematic review registration PROSPERO CRD42020178076. Readers’ note This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication. This version is update 1 of the original article published on 1 September 2020 (BMJ 2020;370:m3320), and previous updates can be found as data supplements (https://www.bmj.com/content/370/bmj.m3320/related#datasupp). When citing this paper please consider adding the update number and date of access for clarity.

https://www.bmj.com/content/bmj/370/bmj.m3320.full.pdf

Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis.

Importance Detailed information about the association of COVID-19 with outcomes in pregnant individuals compared with not-infected pregnant individuals is much needed. Objective To evaluate the risks associated with COVID-19 in pregnancy on maternal and neonatal outcomes compared with not-infected, concomitant pregnant individuals. Design, Setting, and Participants In this cohort study that took place from March to October 2020, involving 43 institutions in 18 countries, 2 unmatched, consecutive, not-infected women were concomitantly enrolled immediately after each infected woman was identified, at any stage of pregnancy or delivery, and at the same level of care to minimize bias. Women and neonates were followed up until hospital discharge. Exposures COVID-19 in pregnancy determined by laboratory confirmation of COVID-19 and/or radiological pulmonary findings or 2 or more predefined COVID-19 symptoms. Main Outcomes and Measures The primary outcome measures were indices of (maternal and severe neonatal/perinatal) morbidity and mortality; the individual components of these indices were secondary outcomes. Models for these outcomes were adjusted for country, month entering study, maternal age, and history of morbidity. Results A total of 706 pregnant women with COVID-19 diagnosis and 1424 pregnant women without COVID-19 diagnosis were enrolled, all with broadly similar demographic characteristics (mean [SD] age, 30.2 [6.1] years). Overweight early in pregnancy occurred in 323 women (48.6%) with COVID-19 diagnosis and 554 women (40.2%) without. Women with COVID-19 diagnosis were at higher risk for preeclampsia/eclampsia (relative risk [RR], 1.76; 95% CI, 1.27-2.43), severe infections (RR, 3.38; 95% CI, 1.63-7.01), intensive care unit admission (RR, 5.04; 95% CI, 3.13-8.10), maternal mortality (RR, 22.3; 95% CI, 2.88-172), preterm birth (RR, 1.59; 95% CI, 1.30-1.94), medically indicated preterm birth (RR, 1.97; 95% CI, 1.56-2.51), severe neonatal morbidity index (RR, 2.66; 95% CI, 1.69-4.18), and severe perinatal morbidity and mortality index (RR, 2.14; 95% CI, 1.66-2.75). Fever and shortness of breath for any duration was associated with increased risk of severe maternal complications (RR, 2.56; 95% CI, 1.92-3.40) and neonatal complications (RR, 4.97; 95% CI, 2.11-11.69). Asymptomatic women with COVID-19 diagnosis remained at higher risk only for maternal morbidity (RR, 1.24; 95% CI, 1.00-1.54) and preeclampsia (RR, 1.63; 95% CI, 1.01-2.63). Among women who tested positive (98.1% by real-time polymerase chain reaction), 54 (13%) of their neonates tested positive. Cesarean delivery (RR, 2.15; 95% CI, 1.18-3.91) but not breastfeeding (RR, 1.10; 95% CI, 0.66-1.85) was associated with increased risk for neonatal test positivity. Conclusions and Relevance In this multinational cohort study, COVID-19 in pregnancy was associated with consistent and substantial increases in severe maternal morbidity and mortality and neonatal complications when pregnant women with and without COVID-19 diagnosis were compared. The findings should alert pregnant individuals and clinicians to implement strictly all the recommended COVID-19 preventive measures.

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Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study.

José Villar, MD; Shabina Ariff, MD; Robert B. Gunier, PhD; Ramachandran Thiruvengadam, MD; Stephen Rauch, MPH; Alexey Kholin, MD; Paola Roggero, PhD; Federico Prefumo, PhD; Marynéa Silva do Vale, MD; Jorge Arturo Cardona-Perez, MD; Nerea Maiz, PhD; Irene Cetin, MD; Valeria Savasi, PhD; Philippe Deruelle, PhD; Sarah Rae Easter, MD; Joanna Sichitiu, MD; Constanza P. Soto Conti, MD; Ernawati Ernawati, PhD; Mohak Mhatre, MD; Jagjit Singh Teji, MD; Becky Liu, MBBS; Carola Capelli, MD; Manuela Oberto, MD; Laura Salazar, MD; Michael G. Gravett, MD; Paolo Ivo Cavoretto, PhD; Vincent Bizor Nachinab, MD; Hadiza Galadanci, MSc; Daniel Oros, PhD; Adejumoke Idowu Ayede, MD; Loïc Sentilhes, PhD; Babagana Bako, MD; Mónica Savorani, MD; Hellas Cena, PhD; Perla K. García-May, MD; Saturday Etuk, MD; Roberto Casale, MD; Sherief Abd-Elsalam, PhD; Satoru Ikenoue, PhD; Muhammad Baffah Aminu, MD; Carmen Vecciarelli, MD; Eduardo A. Duro, MD; Mustapha Ado Usman, MBBS; Yetunde John-Akinola, PhD; Ricardo Nieto, MD; Enrico Ferrazi, MD; Zulfiqar A. Bhutta, PhD; Ana Langer, MD; Stephen H. Kennedy, MD; Aris T. Papageorghiou, MD

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Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study

To evaluate the effect of the COVID-19 pandemic on anxiety and depression of women during pregnancy and perinatal period. We systematically searched online databases to identify any report on mater...

COVID-19 pandemic and maternal mental health: a systematic review and meta-analysis.

The COVID-19 pandemic and subsequent lockdown and social distancing led to changes to breastfeeding support available to women in the United Kingdom. Face-to-face professional support was reduced, and face-to-face peer support was cancelled. Anecdotal media accounts highlighted practices separating some mothers and babies in hospitals, alongside inaccurate stories of the safety of breastfeeding circulating. Meanwhile, new families were confined to their homes, separated from families and support networks. Given that we know breastfeeding is best supported by practices that keep mother and baby together, high-quality professional and peer-to-peer support, and positive maternal well-being, it is important to understand the impact of the pandemic upon the ability to breastfeed. To explore this, we conducted an online survey with 1219 breastfeeding mothers in the United Kingdom with a baby 0-12 months old to understand the impact of the pandemic upon breastfeeding duration, experiences and support. The results highlighted two very different experiences: 41.8% of mothers felt that breastfeeding was protected due to lockdown, but 27.0% of mothers struggled to get support and had numerous barriers stemming from lockdown with some stopped breastfeeding before they were ready. Mothers with a lower education, with more challenging living circumstances and from Black and minority ethnic backgrounds were more likely to find the impact of lockdown challenging and stop breastfeeding. The findings are vital in understanding how we now support those women who may be grieving their loss of breastfeeding and are affected by their negative experiences and how we can learn from those with a positive experience to make sure all breastfeeding women are better supported if similar future events arise.

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Experiences of breastfeeding during COVID-19: Lessons for future practical and emotional support

Introduction: Depression and anxiety affect one in seven women during the perinatal period, and are associated with increased risk of preterm delivery, reduced mother-infant bonding, and delays in cognitive/emotional development of the infant. With this survey we aimed to rapidly assess the influence of the COVID-19 pandemic and subsequent physical distancing/isolation measures on the mental health and physical activity of pregnant and postpartum women. Methods: Between April 14 and May 8, 2020, we recruited women who were pregnant or within the first year after delivery to participate in an online survey. This included questionnaires on self-reported levels of depression/depressive symptoms (Edinburgh Postnatal Depression Survey; EPDS), anxiety (State-Trait Anxiety Inventory; STAI-State), and physical activity. Current and pre-pandemic values were assessed for each. Results: Of 900 eligible women, 520 (58%) were pregnant and 380 (42%) were in the first year after delivery. Sixty-four percent of women reported reduced physical activity with the onset of isolation measures, while 15% increased, and 21% had no change to their physical activity. An EPDS score >13 (indicative of depression) was self-identified in 15% of respondents pre-pandemic and in 40.7% currently (mean ± SD; 7.5 ± 4.9 vs. 11.2 ± 6.3, respectively; p 40) was identified in 29% of women before the pandemic (mean STAI = 34.5 ± 11.4) vs. 72% of women currently (mean STAI = 48.1 ± 13.6; p < 0.01, large effect). However, women engaging in at least 150 min of moderate intensity physical activity (meeting current guidelines) during the pandemic had significantly lower scores for both anxiety and depression than those who did not (p < 0.01, large and small effect, respectively). Discussion: This rapid response survey identifies a substantial increase in the likelihood of maternal depression and anxiety during the COVID-19 pandemic. This highlights the strong need for heightened assessment and treatment of maternal mental health. However, these data also suggest that physical activity, which has previously been shown to reduce depression and depressive symptoms in pregnancy, may be associated with better mental health during the pandemic.

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Moms Are Not OK: COVID-19 and Maternal Mental Health.

PURPOSE This study aimed to evaluate postpartum maternal health and training outcomes of females who were competing or training as elite athletes before or during pregnancy. METHODS Online databases were searched up to August 26, 2020. Studies of any design and language were eligible if they contained information on the relevant population (postpartum athletes [any period after pregnancy]), exposure (engaged in the highest level of sport immediately before or during pregnancy), comparators (sedentary/active controls), and outcomes: maternal (breastfeeding initiation and duration, postpartum weight retention or loss, bone mineral density, low back or pelvic girdle pain, incontinence [prevalence or severity of stress, urge or mixed urinary incontinence, fecal incontinence], injury, anemia, diastasis recti, breast pain, depression, anxiety) and training (<6 wk time to resume activity, training volume or intensity, performance level). RESULTS Eleven studies (n = 482 females, including 372 elite athletes) were included. We identified "very low" certainty evidence demonstrating a higher rate of return to sport before 6 wk postpartum among elite athletes compared with nonelite athletes (n = 145, odds ratio = 6.93, 95% confidence interval = 2.73-17.63, I2 = 11). "Very low" certainty evidence from three studies (n = 179) indicated 14 elite athletes obtained injuries postpartum (7 stress fractures, 9 "running injuries"). "Very low" certainty evidence from five studies (n = 262) reported that 101 (40.5%) elite athletes experienced improved performance postpartum. CONCLUSION Compared with controls, "very low" quality evidence suggests that elite athletes return to physical activity early in the postpartum period and may have an increased risk of injury. Additional high-quality evidence is needed to safely guide return to sport of elite athletes in the postpartum period.

Health Outcomes after Pregnancy in Elite Athletes: A Systematic Review and Meta-analysis.

Abstract Background The Implementation Leadership Scale (ILS) was developed to assess leadership behavior with regard to being proactive, knowledgeable, supportive, or perseverant in implementing evidence-based practices (EBPs). As part of a study on the implementation of a digitally supported polypharmacy management application in primary care, the original ILS was translated and validated for use in the German language. Rationale This study aimed to translate the original ILS into German and evaluate its psychometric properties. Methods The validation sample consisted of 198 primary care physicians in a cluster-randomized controlled trial in which the intervention group implemented a digitally supported clinical decision support system for polypharmacy management. The ILS was assessed using a 12-item scale. The study included a process evaluation with two evaluation waves between 2019 and 2021. The ILS was used within this process evaluation study to assess the leadership support with regard to the implementation of the polypharmacy management. The ILS was translated in a multi-step process, including pre-testing of the instrument and triple, back-and-forth translation of the instrument. We tested the reliability (Cronbach’s alpha) and validity (construct and criterion-related validity) of the scale. Results The four-dimensional structure of the instrument was confirmed (comparative fit index = .97; root mean square error of approximation = .06). Convergent validity was demonstrated by correlations with organizational innovation climate, social capital, and workload, which was consistent with the proposed hypothesis. Criterion-related validity of the ILS was demonstrated by predicting the organizational readiness for change scores using structural equation modeling. The reliability of the scale was good (α = .875). Conclusion The German version of the ILS created in this study is a reliable and valid measure. The original four-dimensional structure of the ILS was confirmed in a primary care setting. Further psychometric testing is needed to establish the validity and reliability of the ILS and to transfer it to other health care settings. It is a useful tool for identifying the areas for implementation leadership development. Further research is needed on how, why, and when distinct types of leadership behaviors have different effects on healthcare organizations in implementation processes. 

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How is leadership behavior associated with organization-related variables? Translation and psychometric evaluation of the implementation leadership scale in German primary healthcare

Sarah Meyer

Papers

Moms Are Not OK: COVID-19 and Maternal Mental Health.

Health Outcomes after Pregnancy in Elite Athletes: A Systematic Review and Meta-analysis.

How is leadership behavior associated with organization-related variables? Translation and psychometric evaluation of the implementation leadership scale in German primary healthcare