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Maternal and Neonatal Morbidity and Mortality Among Pregnant Women With and Without COVID-19 Infection: The INTERCOVID Multinational Cohort Study.
Villar, J, Ariff, S, Gunier, RB, Thiruvengadam, R, Rauch, S, Kholin, A, Roggero, P, Prefumo, F, do Vale, MS, Cardona-Perez, JA, et al
JAMA pediatrics. 2021;(8):817-826
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Abstract
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 natural killer cells at the intersection between reproduction and mucosal immunity.
Shmeleva, EV, Colucci, F
Mucosal immunology. 2021;(5):991-1005
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Many maternal immune cells populate the decidua, which is the mucosal lining of the uterus transformed during pregnancy. Here, abundant natural killer (NK) cells and macrophages help the uterine vasculature adapt to fetal demands for gas and nutrients, thereby supporting fetal growth. Fetal trophoblast cells budding off the forming placenta and invading deep into maternal tissues come into contact with these and other immune cells. Besides their homeostatic functions, decidual NK cells can respond to pathogens during infection, but in doing so, they may become conflicted between destroying the invader and sustaining fetoplacental growth. We review how maternal NK cells balance their double duty both in the local microenvironment of the uterus and systemically, during toxoplasmosis, influenza, cytomegalovirus, malaria and other infections that threat pregnancy. We also discuss recent developments in the understanding of NK-cell responses to SARS-Cov-2 infection and the possible dangers of COVID-19 during pregnancy.
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Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.
Taylor, MM, Kobeissi, L, Kim, C, Amin, A, Thorson, AE, Bellare, NB, Brizuela, V, Bonet, M, Kara, E, Thwin, SS, et al
The Lancet. Global health. 2021;(3):e366-e371
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Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.
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COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
Luxi, N, Giovanazzi, A, Capuano, A, Crisafulli, S, Cutroneo, PM, Fantini, MP, Ferrajolo, C, Moretti, U, Poluzzi, E, Raschi, E, et al
Drug safety. 2021;(12):1247-1269
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To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit-risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories.
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COVID-19: Relationship and Impact on Breastfeeding-A Systematic Review.
Pérez-Bermejo, M, Peris-Ochando, B, Murillo-Llorente, MT
Nutrients. 2021;(9)
Abstract
COVID-19 is an infectious disease caused by the SARS-CoV-2 virus that was declared a Public Health Emergency of International Concern by the World Health Organization (WHO). One major problem faced is whether breastfeeding by mothers infected with the virus is safe. The objective of this work is to study the impact that the SARS-CoV-2 virus can have on breastfeeding, and whether the virus or antibodies can be transmitted from mother to child through milk. We carried out a systematic review of studies focusing on the impact of SARS-CoV-2 on breastfeeding by mothers infected with the virus. The bibliographic search was done through Medline (Pubmed), MedlinePlus and Google Scholar. From 292 records, the title and summary of each were examined according to the criteria, and whether they meet the selection criteria was also analysed. A total of 30 articles are included, of which 26 deal with the study of RNA virus in breastmilk and its involvement in breastfeeding and four on the study of SARS-CoV-2 antibodies in milk. Most studies have been conducted in China. Breastfeeding by mothers infected with SARS-CoV-2 is highly recommended for infants, if the health of the mother and the infant allow for it. Direct breastfeeding and maintaining appropriate protective measures should be encouraged. Should the mother's health condition not permit direct breastfeeding, infants should be fed with pumped breastmilk or donor milk.
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[Recommendations and practical management of pregnant women with COVID-19: A scoping review].
González-de la Torre, H, Rodríguez-Rodríguez, R, Martín-Martínez, A
Enfermeria clinica (English Edition). 2021;:S100-S106
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AIM: To compile recommendations and evidence on the practical management of pregnant women with COVID-19 in order to clarify standards of obstetric care in the face of this new disease. METHOD Scoping review based on literature searches in national and international health science databases (PubMed/Medline, Biblioteca Virtual en Salud, SciELO, Cochrane and CUIDEN) and websites, and additionally by a "snowball" system. MeSH terms were used: "COVID-19", "Pregnancy", "Delivery, Obstetric", "Pregnant Women" and "Maternal". As limits in the search Spanish and English languages were selected. No limits were established in relation to the year of publication or type of article. RESULTS A total of 49 documents and articles were detected, of which 27 were analyzed, 18 were used, and 9 were discarded because they did not contain practical recommendations. The recommendations were grouped into 10 subjects: Prevention of infection in pregnant women; prevention of infection in health care personnel attending pregnant women; form of presentation and severity in pregnant women; maternal-fetal transmission (vertical and perinatal); maternal-fetal control of the pregnant woman with COVID-19; control of the severely pregnant woman with COVID-19; treatment of the pregnant woman with COVID-19; management and route of termination of labor; neonatal outcomes in women with COVID-19, and breastfeeding. CONCLUSIONS Lack of strong evidence to support many of the recommendations for pregnant women with COVID-19, as they are based on previous experience with SARS-CoV and MERS-CoV infections. Further studies are needed to confirm the appropriateness of many of the recommendations and guidelines for action in the specific case of pregnant women and COVID-19.
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Maternal and perinatal outcomes and pharmacological management of Covid-19 infection in pregnancy: a systematic review protocol.
Thomas, B, Pallivalapila, A, El Kassem, W, Tarannum, A, Al Hail, F, Rijims, M, Parappil, H, Bayo, AI, Ahmad, S, Nazar, Z, et al
Systematic reviews. 2020;(1):161
Abstract
BACKGROUND Over 4.2 million confirmed cases and more than 285,000 deaths, COVID-19 pandemic continues to harm significant number of people worldwide. Several studies have reported the impact of COVID-19 in general population; however, there is scarcity of information related to pharmacological management and maternal and perinatal outcomes during the pandemic. Altered physiological, anatomical, and immunological response during pregnancy makes it more susceptible to infections. Furthermore, during pregnancy, a woman undergoes multiple interactions with the health care system that increases her chance of getting infected; therefore, managing pregnant population presents a unique challenge. RESEARCH QUESTIONS This systematic review seeks to answer the following questions in relation to COVID-19: What are the different clinical characteristics presented in maternal and perinatal population? What are the different maternal and perinatal outcome measures reported? What are the distinct therapeutic interventions reported to treat COVID-19? Is it safe to use "medications" used in the treatment of COVID-19 during antenatal, perinatal, postnatal, and breastfeeding? METHOD The search will follow a comprehensive, sequential three step search strategy. Several databases relevant to COVID-19 and its impact on pregnancy including Medline, CINAHL, and LitCovid will be searched from the inception of the disease until the completion of data collection. The quality of this search strategy will be assessed using Peer Review of Electronic Search Strategies Evidence-Based Checklist (PRESS EBC). An eligibility form will be developed for a transparent screening and inclusion/exclusion of studies. All studies will be sent to RefWorks, and abstraction will be independently performed by two researchers. Risk of bias will be assessed using Cochrane Risk of Bias tool for randomized controlled trials, Newcastle-Ottawa Quality Assessment Scale for non-randomized studies, and for case reports, Murad et al. tool will be used. Decision to conduct meta-analysis will be based on several factors including homogeneity and outcome measures reported; otherwise, a narrative synthesis will be deemed appropriate. DISCUSSION This systematic review will summarize the existing data on effect of COVID-19 on maternal and perinatal population. Furthermore, to the best of our knowledge, this is the first systematic review addressing therapeutic management and safety of medicines to treat COVID-19 during pregnancy and breastfeeding. SYSTEMATIC REVIEW REGISTRATION This systematic review has been registered and published with Prospero ( CRD42020172773 ).
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Impact of Maternal Severe Acute Respiratory Syndrome Coronavirus 2 Detection on Breastfeeding Due to Infant Separation at Birth.
Popofsky, S, Noor, A, Leavens-Maurer, J, Quintos-Alagheband, ML, Mock, A, Vinci, A, Magri, E, Akerman, M, Noyola, E, Rigaud, M, et al
The Journal of pediatrics. 2020;:64-70
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OBJECTIVE To assess the impact of separation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR)-positive mother-newborn dyads on breastfeeding outcomes. STUDY DESIGN This observational longitudinal cohort study of mothers with SARS-CoV-2 PCR-and their infants at 3 NYU Langone Health hospitals was conducted between March 25, 2020, and May 30, 2020. Mothers were surveyed by telephone regarding predelivery feeding plans, in-hospital feeding, and home feeding of their neonates. Any change prompted an additional question to determine whether this change was due to coronavirus disease-2019 (COVID-19). RESULTS Of the 160 mother-newborn dyads, 103 mothers were reached by telephone, and 85 consented to participate. There was no significant difference in the predelivery feeding plan between the separated and unseparated dyads (P = .268). Higher rates of breastfeeding were observed in the unseparated dyads compared with the separated dyads both in the hospital (P < .001) and at home (P = .012). Only 2 mothers in each group reported expressed breast milk as the hospital feeding source (5.6% of unseparated vs 4.1% of separated). COVID-19 was more commonly cited as the reason for change in the separated group (49.0% vs 16.7%; P < .001). When the dyads were further stratified by symptom status into 4 groups-asymptomatic separated, asymptomatic unseparated, symptomatic separated, and symptomatic unseparated-the results remained unchanged. CONCLUSIONS In the setting of COVID-19, separation of mother-newborn dyads impacts breastfeeding outcomes, with lower rates of breastfeeding both during hospitalization and at home following discharge compared with unseparated mothers and infants. No evidence of vertical transmission was observed; 1 case of postnatal transmission occurred from an unmasked symptomatic mother who held her infant at birth.
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MS, pregnancy and COVID-19.
Yam, C, Jokubaitis, V, Hellwig, K, Dobson, R
Multiple sclerosis (Houndmills, Basingstoke, England). 2020;(10):1137-1146
Abstract
Concerns regarding infection with the novel coronavirus SARS-CoV-2 leading to COVID-19 are particularly marked for pregnant women with autoimmune diseases such as multiple sclerosis (MS). There is currently a relative paucity of information to guide advice given to and the clinical management of these individuals. Much of the limited available data around COVID-19 and pregnancy derives from the obstetric literature, and as such, neurologists may not be familiar with the general principles underlying current advice. In this article, we discuss the impact of potential infection on the pregnant woman, the impact on her baby, the impact of the current pandemic on antenatal care, and the interaction between COVID-19, MS and pregnancy. This review provides a framework for neurologists to use to guide the individualised advice given to both pregnant women with MS, and those women with MS who are considering pregnancy. This includes evidence derived from previous novel coronavirus infections, and emerging evidence from the current pandemic.
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Maternal transmission of SARS-COV-2 to the neonate, and possible routes for such transmission: a systematic review and critical analysis.
Walker, KF, O'Donoghue, K, Grace, N, Dorling, J, Comeau, JL, Li, W, Thornton, JG
BJOG : an international journal of obstetrics and gynaecology. 2020;(11):1324-1336
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BACKGROUND Early reports of COVID-19 in pregnancy described management by caesarean, strict isolation of the neonate and formula feeding. Is this practice justified? OBJECTIVE To estimate the risk of the neonate becoming infected with SARS-CoV-2 by mode of delivery, type of infant feeding and mother-infant interaction. SEARCH STRATEGY Two biomedical databases were searched between September 2019 and June 2020. SELECTION CRITERIA Case reports or case series of pregnant women with confirmed COVID-19, where neonatal outcomes were reported. DATA COLLECTION AND ANALYSIS Data were extracted on mode of delivery, infant infection status, infant feeding and mother-infant interaction. For reported infant infection, a critical analysis was performed to evaluate the likelihood of vertical transmission. MAIN RESULTS Forty nine studies included information on mode of delivery and infant infection status for 655 women and 666 neonates. In all, 28/666 (4%) tested positive postnatally. Of babies born vaginally, 8/292 (2.7%) tested positivecompared with 20/374 (5.3%) born by Caesarean. Information on feeding and baby separation were often missing, but of reported breastfed babies 7/148 (4.7%) tested positive compared with 3/56 (5.3%) for reported formula fed ones. Of babies reported as nursed with their mother 4/107 (3.7%) tested positive, compared with 6/46 (13%) for those who were reported as isolated. CONCLUSIONS Neonatal COVID-19 infection is uncommon, rarely symptomatic, and the rate of infection is no greater when the baby is born vaginally, breastfed or remains with the mother. TWEETABLE ABSTRACT Risk of neonatal infection with COVID-19 by delivery route, infant feeding and mother-baby interaction.