COVID-19-related medicine utilization study in pregnancy: The COVI-PREG cohort

AIM The objective of this study was to describe the use of COVID-19-related medicines during pregnancy and their evolution between the early/late periods of the pandemic. METHODS Pregnant women who tested positive for SARS-CoV-2 from March 2020 to July 2021 were included using the COVI-PREG registry. Exposure to the following COVID-19-related medicines was recorded: antibiotics, antivirals, hydroxychloroquine, corticosteroids, anti-interleukin-6 and immunoglobulins. We described the prevalence of medicines used, by trimester of pregnancy, maternal COVID-19 severity level and early/late period of the pandemic (before and after 1 July 2020). FINDINGS We included 1964 pregnant patients who tested positive for SARS-CoV-2. Overall, 10.4% (205/1964) received at least one COVID-19-related medicine including antibiotics (8.6%; 169/1694), corticosteroids (3.2%; 62/1964), antivirals (2.0%; 39/1964), hydroxychloroquine (1.4%; 27/1964) and anti-interleukin-6 (0.3%; 5/1964). The use of at least one COVID-19-related medicine was 3.1% (12/381) in asymptomatic individuals, 4.2% (52/1233) in outpatients, 19.7% (46/233) in inpatients without oxygen, 72.1% (44/61) in those requiring standard oxygen, 95.7% (22/23) in those requiring high flow oxygen, 96.2% (25/26) in patients who required intubation and 57.1% (4/7) among patients who died. The proportion who received medicines to treat COVID-19 was higher before than after July 2020 (16.7% vs. 7.7%). Antibiotics, antivirals and hydroxychloroquine had lower rates of use during the late period. CONCLUSION Medicine use in pregnancy increased with disease severity. The trend towards increased use of corticosteroids seems to be aligned with changing guidelines. Evidence is still needed regarding the effectiveness and safety of COVID-19-related medicines in pregnancy

Maternal and perinatal outcomes following pre-Delta, Delta, and Omicron SARS-CoV-2 variants infection among unvaccinated pregnant women in France and Switzerland: a prospective cohort study using the COVI-PREG registry.

BACKGROUND SARS-CoV-2 positive pregnant women are at higher risk of adverse outcomes, but little evidence is available on how variants impact that risk. We aim to evaluate maternal and perinatal outcomes among unvaccinated pregnant women that tested positive for SARS-CoV-2, stratified by pre-Delta, Delta, and Omicron periods. METHODS This prospective study enrolled women from March 2020 to September 2022. Exposure to the different SARS-CoV-2 variants was defined by their periods of predominance. The primary outcome was severe maternal adverse outcome defined as either intensive care unit admission, acute respiratory distress syndrome, advanced oxygen supplementation, or maternal death. The secondary outcomes were preterm birth and other perinatal outcomes. FINDINGS Overall, 1402, 262, and 391 SARS-CoV-2 positive pregnant women were enrolled during the pre-Delta, Delta, and Omicron periods respectively. Severe maternal adverse outcome was reported in 3.4% (n = 947/1402; 95% confidence intervals (95%CI) 2.5-4.5), 6.5% (n = 7/262; 95%CI 3.8-10.2), and 1.0% (n = 4/391; 95%CI 0.3-2.6) of women during the pre-Delta, Delta, and Omicron periods. The risk of severe maternal adverse outcome was higher during the Delta vs pre-Delta period (adjusted risk ratio (aRR) = 1.8; 95%CI 1.1-3.2) and lower during the Omicron vs pre-Delta period (aRR = 0.3; 95%CI, 0.1-0.8). The risks of hospitalization for COVID-19 were 12.6% (n = 176/1402; 95%CI 10.9-14.4), 17.2% (n = 45/262; 95%CI 12.8-22.3), and 12.5% (n = 49/391; 95%CI 9.4-16.2), during the pre-Delta, Delta, and Omicron period, respectively. Pregnancy complications occurred after SARS-CoV-2 exposure in 30.0% (n = 363/1212; 95%CI 27.4-32.6), 35.2% (n = 83/236; 95%CI 29.1-41.6), and 30.3% (n = 105/347; 95%CI 25.5-35.4) of patients during the pre-Delta, Delta, and Omicron periods, respectively. Stillbirths were reported in 0.5% (n = 6/1159; 95%CI 0.2-1.1), 2.8% (n = 6/210; 95%CI 1.0-6.0), and 0.9% (n = 2/213; 95%CI 0.1-3.4) or patients during the pre-Delta, Delta, and Omicron periods respectively. INTERPRETATION The Delta period was associated with a higher risk of severe maternal adverse outcome and the Omicron period with a lower risk of severe adverse outcome compared to pre-Delta era. The reported risk of hospitalization was high during the Omicron period and should not be trivialized. FUNDING Swiss Federal Office of Public Health, Fondation CHUV

Quelle opportunité pour un nouveau modèle de soins obstétricaux au CHUV ?

Introducton : Au cours du XXe siècle, l’accouchement s’est progressivement déplacé du domicile à l’hôpital. Alors que la prise en charge médicalisée a contribué à améliorer les issues pour la mère et l’enfant, on a créé d’autres risques en lien avec les interventions. Devant ces constats, de nombreux pays ont choisi de revoir leur politique de soins dans le domaine de la santé maternelle. L’étude qualitative menée au Centre hospitalier universitaire vaudois (CHUV) visait à évaluer auprès des professionnels et des futures bénéficiaires l’opportunité de créer une unité intrahospitalière, gérée par les sages-femmes, pour le suivi de la grossesse, de l’accouchement et du postpartum lors de situations physiologiques. Les participants se sont montrés favorables à l’ouverture d’une telle unité tout en soulignant les barrières et les attentes spécifiques méritant une attention particulière

COVID-19 related medicine utilization study in pregnancy - the COVI-PREG cohort.

OBJECTIVE The aim was to describe the use of COVID-19 related medicines during pregnancy and their evolution between the early/late periods of the pandemic. METHODS Pregnant women tested positive for SARS-CoV-2 from March 2020, to July 2021, were included using the COVI-PREG registry. Exposure to the following COVID-19 related medicine were recorded: antibiotics, antivirals, hydroxychloroquine, corticosteroids, anti-interleukin-6 and immunoglobulins. We described the prevalence of medicines used, by trimester of pregnancy, maternal COVID-19 severity level and early/late period of the pandemic (before and after July 1 2020). FINDINGS We included 1,964 pregnant patients, tested positive for SARS-CoV-2. Overall, 10.4% (205/1964) received at least one COVID-19 related medicine including antibiotics (8.6%; 169/1694), corticosteroids (3.2%; 62/1964), antivirals (2.0%; 39/1964), hydroxychloroquine (1.4%; 27/1964), and anti-interleukin-6 (0.3%; 5/1964). The use of at least one COVID-19 related medicine was 3.1% (12/381) in asymptomatic, 4.2% (52/1233) in outpatients, 19.7% (46/233) in inpatients without oxygen, 72.1% (44/61) in requiring standard oxygen, 95.7% (22/23) in requiring high flow oxygen, 96.2% (25/26) in intubated and 57.1% (4/7) among patients who died. The proportion who received medicines to treat COVID-19 was higher before than after July 2020 (16.7% vs. 7.7%). Antibiotics, antivirals, and hydroxychloroquine had lower rates of use lately. INTERPRETATION Medicine use in pregnancy was increasing with disease severity. The trend toward increased corticosteroids use seems to be aligned with changing guidelines. Evidence is still needed regarding the effectiveness and safety of COVID-19 related medicines in pregnancy. FUNDING Research funded by the Swiss Federal Office of Public Health

Risk of congenital malformation following first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort.

OBJECTIVES This study aimed to evaluate the risk of congenital malformation among pregnant women exposed to the mRNA COVID-19 vaccines during the first trimester of pregnancy, which is a developmental period where the fetus is at risk of teratogenicity. METHODS Pregnant women were prospectively enrolled from March 2021 to March 2022, at the time of COVID-19 vaccination. Pregnant women exposed to at least one dose of mRNA COVID-19 vaccine from conception to 11 weeks of gestations and 6 days were compared to pregnant women exposed to the vaccine from 12 weeks to the end of pregnancy. The primary outcome was a confirmed congenital malformation at birth. RESULTS A total of 1450 pregnant women were enrolled including 124 in the first trimester and 1326 in the second and third trimester. The overall proportion of congenital malformation was 0.81% (n=1/124; 95%CI 0.02-4.41) and 0.83% (n=11/1326; 95% CI 0.41-1.48) among pregnant exposed to the COVID-19 vaccine during the first and second/third trimester, respectively. First trimester exposure was not associated with a higher risk of congenital malformation with a relative risk (RR) of 0.89 (95%CI 0.12-6.80) with no significant changes after adjustment through exploratory analysis. CONCLUSION Pregnant women exposed to mRNA COVID-19 vaccine before 12 weeks of gestation did not have an increased risk of congenital malformation compared to women exposed outside the teratogenic window. As vaccination is safe and effective, emphasis must be placed on promoting vaccination during pregnancy

Risk of congenital malformation following first trimester mRNA COVID-19 vaccine exposure in pregnancy: the COVI-PREG prospective cohort.

This study aimed to evaluate the risk of congenital malformation among pregnant women exposed to the mRNA COVID-19 vaccines during the first trimester of pregnancy, which is a developmental period where the fetus is at risk of teratogenicity. Pregnant women were prospectively enrolled from March 2021 to March 2022, at the time of COVID-19 vaccination. Pregnant women exposed to at least one dose of mRNA COVID-19 vaccine from conception to 11 weeks of gestations and 6 days were compared to pregnant women exposed to the vaccine from 12 weeks to the end of pregnancy. The primary outcome was a confirmed congenital malformation at birth. A total of 1450 pregnant women were enrolled including 124 in the first trimester and 1326 in the second and third trimester. The overall proportion of congenital malformation was 0.81% (n=1/124; 95%CI 0.02-4.41) and 0.83% (n=11/1326; 95% CI 0.41-1.48) among pregnant exposed to the COVID-19 vaccine during the first and second/third trimester, respectively. First trimester exposure was not associated with a higher risk of congenital malformation with a relative risk (RR) of 0.89 (95%CI 0.12-6.80) with no significant changes after adjustment through exploratory analysis. Pregnant women exposed to mRNA COVID-19 vaccine before 12 weeks of gestation did not have an increased risk of congenital malformation compared to women exposed outside the teratogenic window. As vaccination is safe and effective, emphasis must be placed on promoting vaccination during pregnancy

Width of margins in phyllodes tumors of the breast: the controversy drags on?—a systematic review and meta-analysis

Phyllodes tumors (PT) of the breast are rare fibroepithelial neoplasms. Information is controversial in the literature regarding to the optimal surgical management. Most studies suggested margins of at least 10 mm while some recent studies suggested narrower margins without an increased risk of local recurrences (LR) and distant metastases (DM). The objective of this systematic review was to identify and compare studies that assessed these different practices. A systematic review was performed through five databases up to April 2019. Studies exploring the association between the width of margins, subtypes of PT, and the LR and DM rates were considered for inclusion. A statistical model for analyzing sparse data and rare events was used. Thirteen studies met eligibility criteria and were selected. Considering a threshold of 10 mm (margins < 10 vs margins ≥ 10 mm), the 5-year incidence rate of LR was estimated to be 5.22 vs. 3.63 (diff. -1.59) per 100 person-years for benign PT, 9.60 vs. 7.33 (diff. -2.27) for borderline PT, and 28.58 vs. 21.84 (diff. -6.74) for malignant PT. For DM, it was estimated to be 0.88 vs. 0.86 (diff. -0.02) for benign PT, 1.61 vs. 1.74 (diff. 0.13) for borderline PT, and 4.80 vs 5.18 (diff. 0.38) for malignant PT. The data for a threshold of 1 mm were not sufficient to draw any conclusions. Irrespective of tumor grade, we found that DM was a rarer event than LR. Malignant PT had the highest incidence rate of LR and DM. This meta-analysis found a clear association between width of margins and LR rates. Whatever the tumor grade, surgical margins ≥ 10 mm guaranteed a lower risk of LR than margins < 10 mm. On the other hand, the width of margin did not influence the apparition of DM