Disproportionate impact of abortion restriction: Implications for emergency department clinicians.

Individuals experiencing intimate partner violence (IPV) and/or human trafficking (HT) are at increased risk of severe health consequences as a result of legislation criminalizing and/or restricting abortion, which is expected to increase as a result of the Supreme Court decision Dobbs v. Jackson. These risks are further stratified by race, socioeconomics, and other marginalizing demographic attributes. IPV and HT introduce barriers to maintaining physical and mental health, due to control of access to transportation and funds by the abuser, fear of retribution for seeking healthcare, and other barriers. Individuals experiencing IPV or HT often lack reproductive autonomy, as a result of facing reproductive coercion at the hands of their abusers. Following the Dobbs decision, these vulnerable patient populations will face further limitations on their reproductive autonomy and increased obstacles to obtaining an abortion if they medically need or desire one. This will likely result in more patients presenting to the emergency department due to complications from unsafe or unsupervised self-managed abortions, as well as patients being reluctant to report having obtained an unlawful abortion due to fear of legal consequences. This is particularly relevant to individuals experiencing IPV and HT, as they may be more likely to use these methods for obtaining an abortion due to numerous barriers. Emergency medicine clinicians are vital in providing care to these patients, as they frequently present to emergency departments. A multi-pronged approach to better support these patients is essential, involving an increased index of suspicion for IPV, HT or the complications of unsupervised abortion, improved organizational structures, specialized training for staff, improved screening methods, reflection on implicit bias, and recommendations for mindful documentation and legal considerations.

The impact of the COVID-19 pandemic on adverse fetal outcomes: A cross-sectional study.

The coronavirus disease 2019 (COVID-19) pandemic has been one of the most damaging pandemics in all of human history. Some of the most vulnerable groups within society such as pregnant women and children have also been affected. This observational research, cross-sectional study was conducted to investigate if there was any difference in the incidence of unfavorable outcomes in pregnancy such as miscarriage, intrauterine fetal demise, and early neonatal death during the year prior to the pandemic and the year of the COVID-19 pandemic. This retrospective study was conducted at the University Hospital of Split at the Department of Pathology, Forensic and Cytology and Department of Obstetrics and Gynecology of the same hospital. All data was collected in the time period from March 1st, 2019, to March 1st, 2021. The study included all pregnant women who had an unfavorable pregnancy outcome such as miscarriage and intrauterine fetal demise, as well as early neonatal death at the University Hospital of Split within the time frame mentioned previously. There was no statistically significant difference in the incidence of adverse pregnancy outcomes in the year prior to the pandemic and during the year of the COVID-19 pandemic. Our study showed that the pandemic did not have a negative effect on pregnant women and their fetuses; there was no increase in miscarriage, intrauterine fetal demise, or perinatal death during the year of the pandemic.

COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion.

Importance: Adherence to COVID-19 booster vaccine recommendations has lagged in pregnant and nonpregnant adult populations. One barrier to booster vaccination is uncertainty regarding the safety of booster doses among pregnant people. Objective: To evaluate whether there is an association between COVID-19 booster vaccination during pregnancy and spontaneous abortion. Design, Setting, and Participants: This observational, case-control, surveillance study evaluated people aged 16 to 49 years with pregnancies at 6 to 19 weeks' gestation at 8 health systems in the Vaccine Safety Datalink from November 1, 2021, to June 12, 2022. Spontaneous abortion cases and ongoing pregnancy controls were evaluated during consecutive surveillance periods, defined by calendar time. Exposure: Primary exposure was receipt of a third messenger RNA (mRNA) COVID-19 vaccine dose within 28 days before spontaneous abortion or index date (midpoint of surveillance period in ongoing pregnancy controls). Secondary exposures were third mRNA vaccine doses in a 42-day window or any COVID-19 booster in 28- and 42-day windows. Main Outcomes and Measures: Spontaneous abortion cases and ongoing pregnancy controls were identified from electronic health data using a validated algorithm. Cases were assigned to a single surveillance period based on pregnancy outcome date. Eligible ongoing pregnancy time was assigned to 1 or more surveillance periods as an ongoing pregnancy-period control. Generalized estimating equations were used to estimate adjusted odds ratios (AOR) with gestational age, maternal age, antenatal visits, race and ethnicity, site, and surveillance period as covariates and robust variance estimates to account for inclusion of multiple pregnancy periods per unique pregnancy. Results: Among 112 718 unique pregnancies included in the study, the mean (SD) maternal age was 30.6 (5.5) years. Pregnant individuals were Asian, non-Hispanic (15.1%); Black, non-Hispanic (7.5%); Hispanic (35.6%); White, non-Hispanic (31.2%); and of other or unknown (10.6%); and 100% were female. Across eight 28-day surveillance periods, among 270 853 ongoing pregnancy-period controls, 11 095 (4.1%) had received a third mRNA COVID-19 vaccine in a 28-day window; among 14 226 cases, 553 (3.9%) had received a third mRNA COVID-19 vaccine within 28 days of the spontaneous abortion. Receipt of a third mRNA COVID-19 vaccine was not associated with spontaneous abortion in a 28-day window (AOR, 0.94; 95% CI, 0.86-1.03). Results were consistent when using a 42-day window (AOR, 0.97; 95% CI, 0.90-1.05) and for any COVID-19 booster in a 28-day (AOR, 0.94; 95% CI, 0.86-1.02) or 42-day (AOR, 0.96; 95% CI, 0.89-1.04) exposure window. Conclusions and Relevance: In this case-control surveillance study, COVID-19 booster vaccination in pregnancy was not associated with spontaneous abortion. These findings support the safety of recommendations for COVID-19 booster vaccination, including in pregnant populations.

Late miscarriage and stillbirth in asymptomatic and symptomatic hospitalised pregnant women in Belgium during the first and second waves of COVID-19: a prospective nationwide population-based study.

BACKGROUND: Stillbirth has been recognized as a possible complication of a SARS-CoV-2 infection during pregnancy, probably due to destructive placental lesions (SARS-CoV-2 placentitis). The aim of this work is to analyse stillbirth and late miscarriage cases in unvaccinated pregnant women infected with SARS-CoV-2 during the first two waves (wild-type period) in Belgium. METHODS: Stillbirths and late miscarriages in our prospective observational nationwide registry of SARS-CoV-2 infected pregnant women (n = 982) were classified by three authors using a modified WHO-UMC classification system for standardized case causality assessment. RESULTS: Our cohort included 982 hospitalised pregnant women infected with SARS-CoV-2, with 23 fetal demises (10 late miscarriages from 12 to 22 weeks of gestational age and 13 stillbirths). The stillbirth rate was 9.5‰ for singleton pregnancies and 83.3‰ for multiple pregnancies, which seems higher than for the background population (respectively 5.6‰ and 13.8‰). The agreement between assessors about the causal relationship with SARS-Cov-2 infection was fair (global weighted kappa value of 0.66). Among these demises, 17.4% (4/23) were "certainly" attributable to SARS-CoV-2 infection, 13.0% (3/23) "probably" and 30.4% (7/23) "possibly". Better agreement in the rating was noticed when pathological examination of the placenta and identification of the virus were available, underlining the importance of a thorough investigation in case of intra-uterine fetal demise. CONCLUSIONS: SARS-CoV-2 causality assessment of late miscarriage and stillbirth cases in our Belgian nationwide case series has shown that half of the fetal losses could be attributable to SARS-CoV-2. We must consider in future epidemic emergencies to rigorously investigate cases of intra-uterine fetal demise and to store placental tissue and other material for future analyses.

Cognitive appraisal of health and its influencing factors among pregnant women with gestational diabetes mellitus: A cross-sectional study.

AIM: To investigate the status quo of cognitive appraisal of health and its influencing factors among pregnant women with gestational diabetes mellitus. METHODS: A cross-sectional survey was conducted from June 2020 to November 2020. Participants were recruited from a tertiary hospital by a convenient sample method. A total of 300 pregnant women with gestational diabetes mellitus completed the survey, including self-compiled individual information questionnaire, Cognitive Appraisal of Health Scale, Pregnancy Stress Rating Scale and General Self-Efficacy Scale. RESULTS: For cognitive appraisal of health, the median score of challenge dimension was 3.75 (3.50, 4.00), benign/irrelevant was 2.75 (2.00, 3.50), harm/loss was 2.38 (2.00, 3.00) and threat was 2.40 (2.00, 2.80), respectively. Regression analyses showed that gestational age, mode of conception, history of abortion, insulin usage, pregnancy stress and self-efficacy were the predictors of cognitive appraisal of health. CONCLUSIONS: This study revealed that pregnant women with gestational diabetes mellitus tended to make positive cognitive appraisal of health. And healthcare providers need to make full use of their predictors of cognitive appraisal of health to improve cognitive appraisal to manage stress and ameliorate pregnancy outcomes.

"In some clinics, they said it's elective, and then they would refuse": A Mixed-Methods Study on the impact of the COVID-19 pandemic on access to abortion services in Germany.

OBJECTIVE: The World Health Organization recognizes abortion as essential health care and has encouraged governments to ensure access to abortion services throughout the COVID-19 pandemic. However, the threat of infection combined with government responses to COVID-19 have impacted access to abortion services globally. This study explores access to abortion in Germany during the pandemic. METHODS: This study used a mixed-methods design. An analysis of data collected by Women on Web (WoW) was carried out to assess women's reasons for choosing telemedicine abortion outside the formal health system in Germany during the pandemic. Descriptive statistics were generated for 2057 requests for telemedicine abortion received by WoW between March 2020-March 2021. Semi-structured interviews were conducted with eight healthcare professionals involved in the provision of abortion services to explore how they perceive of women's access to abortion services in Germany during the pandemic. RESULTS: The quantitative analysis found that preferences and needs for privacy (47.3%), secrecy (44.4%) and comfort (43.9%) were the most common reasons for choosing telemedicine abortion. COVID-19 was another important reason (38.8%). The thematic analysis of the interviews was organized into two overarching themes: service provision, and axes of difference. CONCLUSIONS: The pandemic affected the provision of abortion services as well as the circumstances of women seeking abortion. The main barriers to access were financial constraints, privacy issues, and lack of abortion providers. Throughout the pandemic, accessing abortion services was more difficult for many women in Germany, especially women experiencing multiple and overlapping forms of discrimination.

Advancing Reproductive Health through Policy-Engaged Research in Abortion Care.

Mifepristone medication abortion was first approved in China and France more than 30 years ago and is now used in more than 60 countries worldwide. It is a highly safe and effective method that has the potential to increase population access to abortion in early pregnancy, closer to home. In both Canada and the United States, the initial regulations for distribution, prescribing, and dispensing of mifepristone were highly restricted. However, in Canada, where mifepristone was made available in 2017, most restrictions on the medication were removed in the first year of its availability. The Canadian regulation of mifepristone as a normal prescription makes access possible in community primary care through a physician or nurse practitioner prescription, which any pharmacist can dispense. In this approach, people decide when and where to take their medication. We explore how policy-maker-engaged research advanced reproductive health policy and facilitated this rapid change in Canada. We discuss the implications of these policy advances for self-management of abortion and demonstrate how in Canada patients "self-manage" components of the abortion process within a supportive health care system.

The Impact of the COVID-19 Pandemic on the Care of Women Experiencing Abortion in a University Hospital in Brazil.

OBJECTIVE: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on the care of patients with miscarriage and legal termination of pregnancy in a university hospital in Brazil. METHODS: A cross-sectional study of women admitted for abortion due to any cause at Hospital da Mulher Prof. Dr. J. A. Pinotti of Universidade Estadual de Campinas (UNICAMP), Brazil, between July 2017 and September 2021. Dependent variables were abortion-related complications and legal interruption of pregnancy. Independent variables were prepandemic period (until February 2020) and pandemic period (from March 2020). The Cochran-Armitage test, Chi-squared test, Mann-Whitney test, and multiple logistic regression were used for statistical analysis. RESULTS: Five-hundred sixty-one women were included, 376 during the prepandemic period and 185 in the pandemic period. Most patients during pandemic were single, without comorbidities, had unplanned pregnancy, and chose to initiate contraceptive method after hospital discharge. There was no significant tendency toward changes in the number of legal interruptions or complications. Complications were associated to failure of the contraceptive method (odds ratio [OR] 2.44; 95% confidence interval [CI] 1.23-4.84), gestational age (OR 1.126; 95% CI 1.039-1.219), and preparation of the uterine cervix with misoprostol (OR 1.99; 95% CI 1.01-3.96). CONCLUSION: There were no significant differences in duration of symptoms, transportation to the hospital, or tendency of reducing the number of legal abortions and increasing complications. The patients' profile probably reflects the impact of the pandemic on family planning.

OBJETIVO: Avaliar o impacto da pandemia de coronavirus disease 2019 (Covid-19) no atendimento de pacientes com aborto espontâneo e interrupção legal da gravidez em um hospital universitário no Brasil. MéTODOS: Estudo transversal com mulheres admitidas por aborto por qualquer causa no Hospital da Mulher Prof. Dr. J. A. Pinotti da Universidade de Campinas (UNICAMP), Brasil, entre julho de 2017 e setembro de 2021. As variáveis dependentes foram complicações relacionadas ao aborto e interrupção legal da gravidez. As variáveis independentes foram período pré-pandemia (até fevereiro de 2020) e período pandêmico (a partir de março de 2020). O teste de Cochran-Armitage, teste do qui-quadrado, teste de Mann-Whitney e regressão logística múltipla foram utilizados para análise estatística. RESULTADOS: Foram incluídas 561 mulheres, 376 no período pré-pandemia e 185 no período pandêmico. A maioria das pacientes durante a pandemia era solteira, sem comorbidades, teve gravidez não planejada e optou por iniciar método anticoncepcional após a alta hospitalar. Não houve tendência significativa para mudanças no número de interrupções legais ou complicações. As complicações foram associadas a: falha do método contraceptivo (razão de chances [RC] 2,44; intervalo de confiança [IC] 95% 1,23­4,84), idade gestacional (RC 1,126; IC 95% 1,039­1,219) e preparo do colo uterino com misoprostol (RC 1,99; IC 95% 1,01­3,96). CONCLUSãO: Não houve diferenças significativas na duração dos sintomas, transporte ao hospital ou tendência de redução do número de abortos legais e aumento de complicações. O perfil das pacientes provavelmente reflete o impacto da pandemia no planejamento familiar.

Effect of female coronavirus disease 2019 vaccination on assisted reproductive outcomes: a systematic review and meta-analysis.

IMPORTANCE: The effect of coronavirus disease 2019 (COVID-19) vaccination on fertility warrants clarification in women undergoing assisted reproductive treatment. OBJECTIVE: To study the association between female COVID-19 vaccination and outcomes of assisted reproductive treatment. DATA SOURCES: PubMed, Embase, the Web of Science, Cochrane Library, and medRxiv and bioRxiv were searched for eligible studies from December 1, 2019, to November 30, 2022, with no language restrictions. STUDY SELECTION AND SYNTHESIS: Observational studies comparing assisted reproductive outcomes between women with and without COVID-19 vaccination were included. The pooled estimates were calculated using the random-effects models as mean differences (MDs), standardized MDs, or odds ratios with 95% confidence intervals (CIs). Heterogeneity was evaluated using the I2 statistic. MAIN OUTCOMES: The number of oocytes retrieved and clinical pregnancy rate. RESULTS: Twenty-one cohort studies involving a total of 19,687 treatment cycles were included. In a comparison of the vaccinated vs. unvaccinated groups, the pooled MD for oocyte number was -0.06 (95% CI, -0.51 to 0.39; I2 = 0), and the pooled odds ratio for clinical pregnancy was 0.95 (95% CI, 0.85-1.05; I2 = 0). Similarly, there were no statistically significant adverse effects identified in other outcomes determined a priori, including 4 cycle characteristics, 6 laboratory parameters, and 3 pregnancy indicators. Most results were consistently unchanged in subgroup and sensitivity analyses, with no evidence of publication bias according to Egger's test. CONCLUSION AND RELEVANCE: Our work did not find significant differences in assisted reproductive outcomes between vaccinated and unvaccinated women. However, more data are warranted to confirm the safety of COVID-19 vaccination for assisted reproductive treatment and in female fertility in general.

Decreasing reproductive and abortion care barriers: findings on the student health center's role from a student survey.

BACKGROUND: College-aged young adults in the US have low utilization and high need for reproductive healthcare. Multiple barriers to reproductive care exist. University Student Health Centers (SHCs) provide varying degrees of reproductive products and services. Recently, California legislated that public university SHCs add medication abortion to their care. METHODS: To examine existing attitudes and barriers to reproductive healthcare for public university students, we conducted an anonymous online survey at a large, diverse, urban coastal California State University. Students were asked about numerous barriers accessing reproductive services in general and at the SHC, which we categorized into three groups: stigma, access and system. Respondents were also asked about knowledge and preferences for accessing and recommending various services. To understand the extent to which inequities exist, we compared differences across racialized/ethnic identity, gender identity, anticipated degree, and living distance from campus using chi-squared tests. RESULTS: The majority of survey (n = 273) respondents experienced stigma and access barriers in general healthcare settings which made obtaining reproductive healthcare for themselves or their partners difficult (stigma barriers 55%; 95% CI 49%-61%; access barriers 68%; 95% CI 62-73%). Notably, students reported statistically significant lower rates of access barriers at the SHC, 50%, than in general reproductive healthcare settings, 68%. There were limited differences by student demographics. Students also reported a high willingness to use or recommend the SHC for pregnancy tests (73%; 95% CI 67-78%), emergency contraception pills (72%; 95% CI 66-78%) and medication abortion (60%; 95% CI 54-66%). Students were less likely to know where to access medication abortion compared to other services, suggesting unmet need. CONCLUSIONS: Our study provides evidence that students face barriers accessing reproductive healthcare and that SHCs are a trusted and accessible source of this care. SHCs have a key role in increasing health, academic and gender equity in the post-Roe era. Attention and financial support must be paid to SHCs to ensure success as state legislatures mandate them to expand reproductive and abortion care access.

The risk of miscarriage following COVID-19 vaccination: a systematic review and meta-analysis.

STUDY QUESTION: What is the risk of miscarriage among pregnant women who received any of the COVID-19 vaccines? SUMMARY ANSWER: There is no evidence that COVID-19 vaccines are associated with an increased risk of miscarriage. WHAT IS KNOWN ALREADY: In response to the COVID-19 pandemic, the mass roll-out of vaccines helped to boost herd immunity and reduced hospital admissions, morbidity, and mortality. Still, many were concerned about the safety of vaccines for pregnancy, which may have limited their uptake among pregnant women and those planning a pregnancy. STUDY DESIGN, SIZE, DURATION: For this systematic review and meta-analysis, we searched MEDLINE, EMBASE, and Cochrane CENTRAL from inception until June 2022 using a combination of keywords and MeSH terms. PARTICIPANTS/MATERIALS, SETTING, METHODS: We included observational and interventional studies that enrolled pregnant women and evaluated any of the available COVID-19 vaccines compared to placebo or no vaccination. We primarily reported on miscarriage in addition to ongoing pregnancy and/or live birth. MAIN RESULTS AND THE ROLE OF CHANCE: We included data from 21 studies (5 randomized trials and 16 observational studies) reporting on 149 685 women. The pooled rate of miscarriage among women who received a COVID-19 vaccine was 9% (n = 14 749/123 185, 95% CI 0.05-0.14). Compared to those who received a placebo or no vaccination, women who received a COVID-19 vaccine did not have a higher risk of miscarriage (risk ratio (RR) 1.07, 95% CI 0.89-1.28, I2 35.8%) and had comparable rates for ongoing pregnancy or live birth (RR 1.00, 95% CI 0.97-1.03, I2 10.72%). LIMITATIONS, REASONS FOR CAUTION: Our analysis was limited to observational evidence with varied reporting, high heterogeneity and risk of bias across included studies, which may limit the generalizability and confidence in our findings. WIDER IMPLICATIONS OF THE FINDINGS: COVID-19 vaccines are not associated with an increase in the risk of miscarriage or reduced rates of ongoing pregnancy or live birth among women of reproductive age. The current evidence remains limited and larger population studies are needed to further evaluate the effectiveness and safety of COVID-19 vaccination in pregnancy. STUDY FUNDING/COMPETING INTEREST(S): No direct funding was provided to support this work. M.P.R. was funded by the Medical Research Council Centre for Reproductive Health Grant No: MR/N022556/1. B.H.A.W. hold a personal development award from the National Institute of Health Research in the UK. All authors declare no conflict of interest. REGISTRATION NUMBER: CRD42021289098.

Rates of Spontaneous Abortion in Israel Before and During the COVID-19 Pandemic.

This cross-sectional study uses electronic health record data to compare monthly incidence rates of spontaneous abortion in Israel before and during the COVID-19 pandemic.

COVID-19 is not a causal risk for miscarriage: evidence from a Mendelian randomization study.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) has caused a global pandemic in the last three years. The lack of reliable evidence on the risk of miscarriage due to COVID-19 has become a concern for patients and obstetricians. We sought to identify rigorous evidence using two-sample Mendelian randomization (MR) analysis. METHODS: Seven single-nucleotide polymorphisms (SNPs) associated with COVID-19 were used as instrumental variables to explore causality by two-sample MR. The summary data of genetic variants were obtained from the Genome Wide Association Study (GWAS) among European populations in the UK Biobank and EBI database. Inverse variance weighting (IVW) method was taken as the gold standard for MR results, and other methods were taken as auxiliary. We also performed sensitivity analysis to evaluate the robustness of MR. RESULTS: The MR analysis showed there was no clear causal association between COVID-19 and miscarriage in the genetic prediction [OR 0.9981 (95% CI, 0.9872-1.0091), p = 0.7336]. Sensitivity analysis suggested that the MR results were robust [horizontal pleiotropy (MR-Egger, intercept = 0.0001592; se = 0.0023; p = 0.9480)]. CONCLUSIONS: The evidence from MR does not support COVID-19 as a causal risk factor for miscarriage in European populations. The small probability of direct placental infection, as well as the inability to stratify the data may explain the results of MR. These findings can be informative for obstetricians when managing women in labor.

SARS-CoV-2 placentitis and severe pregnancy outcome after maternal infection: A Danish case series.

INTRODUCTION: SARS-CoV-2 infection during pregnancy may cause viral inflammation of the placenta, resulting in fetal demise even without fetal or newborn infection. The impact of timing of the infection and the mechanisms that cause fetal morbidity and mortality are not well understood. MATERIAL AND METHODS: To describe placental pathology from women with confirmed SARS-CoV-2 infection during pregnancy, a SARS-CoV-2 immunohistochemistry-positive placenta and late miscarriage, stillbirth, neonatal death, or medically indicated birth due to fetal distress. RESULTS: The triad of trophoblastic necrosis, inflammatory intervillous infiltrates, and increased perivillous fibrinoid deposition was present in all 17 placentas; the pregnancies resulted in eight stillbirths, two late miscarriages (19 and 21 weeks' gestation), and seven liveborn children, two of which died shortly after delivery. The severity of maternal COVID-19 was not reflected by the extent of the placental lesions. In only one case, SARS-CoV-2 was detected in lung tissue samples from the fetus. The majority events (miscarriage, stillbirth, fetal distress resulting in indicated birth, or livebirth, but neonatal death) happened shortly after maternal SARS-CoV-2 infection was diagnosed. Seven of eight sequenced cases were infected with the Delta (B.1.617.2) virus strain. CONCLUSION: We consolidate findings from previous case series describing extensive SARS-CoV-2 placentitis and placental insufficiency leading to fetal hypoxia. We found sparse evidence to support the notion that SARS-CoV-2 virus had infected the fetus or newborn.

Strategies to Address COVID-19 Vaccine and Pregnancy Myths.

ABSTRACT: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses risks to pregnant women and their infants. The spread of misinformation about COVID-19 vaccination is a barrier to optimizing vaccination rates among women of childbearing age. We conducted an environmental scan to identify misinformation about COVID-19 vaccination, pregnancy, and fertility, and a review to identify evidence to refute misinformation and strategies to correct and prevent the spread of misinformation. Seven identified themes of misinformation are: the vaccine causes female infertility; can cause miscarriage; and can decrease male fertility; mRNA vaccines attack the placenta; pregnant and breastfeeding persons should not get the vaccine; the vaccine can change menstrual cycles; and vaccinated people can spread infertility symptoms to unvaccinated people. Strategies that can be implemented by social media platforms to help prevent misinformation spread and correct existing health misinformation include improving information regulation by modifying community standards, implementing surveillance algorithms, and applying warning labels to potentially misleading posts. Health services organizations and clinicians can implement health misinformation policies, directly recommend vaccinations, provide credible explanations and resources to debunk misinformation, educate patients and populations on spotting misinformation, and apply effective communication strategies. More research is needed to assess longer-term effects of vaccination among women of childbearing age to strengthen the defense against misinformation and to evaluate strategies that aim to prevent and correct misinformation spread about COVID-19 vaccinations.

mRNA COVID-19 vaccination early in pregnancy and the risk of spontaneous abortion in an international pregnancy registry.

PURPOSE: mRNA COVID-19 vaccines are used in pregnant populations whether advertently or inadvertently. However, evidence on the safety of these vaccines during pregnancy is limited. The objective of this study is to evaluate the effect of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccination during the first 20 weeks of gestation on the risk of spontaneous abortion (SAB). METHODS: All pregnant women who received at least one dose of BNT162b2 or mRNA-1273 and enrolled in the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) were prospectively followed from enrollment until 20 weeks of gestation, SAB, or loss to follow-up. Baseline demographics, vaccination information, and pregnancy outcomes were collected via monthly online self-administered questionnaires, vaccination certificates, and medical records. Life tables were used to calculate the cumulative risk of SAB. Cox regression was used to estimate the hazard ratio (HR) comparing the two vaccines groups stratified by country of residence and gestational age at enrollment. RESULTS: Among 6840 participants who received at least one dose of BNT162b2 or mRNA-1273 at any time in pregnancy between Jan-Sep, 2021, 2129 met the inclusion criteria (1576 received BNT162b2 and 553 mRNA-1273). The two groups were balanced in terms of baseline characteristics. There were 37 SABs, with an overall 13.4% estimated cumulative risk by 20 weeks of gestation, which is similar to the expected risk in the population. The HR of SAB comparing mRNA-1273 to BNT162b2 was 1.46 (95% CI: 0.66, 3.22). CONCLUSION: The C-VIPER data show no evidence that mRNA COVID-19 vaccines increase the risk of SAB.

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study.

BACKGROUND: We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants. METHODS: This ongoing phase 2/3, double-blind, placebo-controlled, randomized trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart. Here, we present the safety results of SCB-2019 over the 6-month period following 2-dose primary vaccination series in all adult participants (≥18 years of age). RESULTS: A total of 30,137 adult participants received at least one dose of study vaccine (n = 15,070) or placebo (n = 15,067) between 24 March 2021 and 01 December 2021. Unsolicited adverse events, medically-attended adverse events, adverse events of special interest, and serious adverse events were reported in similar frequencies in both study arms over the 6-month follow-up period. Vaccine-related SAEs were reported by 4 of 15,070 SCB-2019 recipients (hypersensitivity reactions in two participants, Bell's palsy, and spontaneous abortion) and 2 of 15,067 placebo recipients (COVID-19, pneumonia, and acute respiratory distress syndrome in one participant and spontaneous abortion in the other one). No signs of vaccine-associated enhanced disease were observed. CONCLUSIONS: SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination. CLINICAL TRIALS REGISTRATION: NCT04672395; EudraCT: 2020-004272-17.

Safety of COVID-19 vaccination in women undergoing IVF/ICSI treatment - Clinical study and systematic review.

Background: It was suggested that vaccination in general might affect reproductive health. Safety of COVID-19 vaccination in women undergoing assisted reproductive techniques (ART) treatment is not well established. Methods: We performed a retrospective study including 536 women undergoing fresh embryo transfer after IVF/ICSI treatment in a huge IVF center in southern China to investigate the effect of COVID-19 vaccination on oocyte maturation, fertilization rate, blastulation rate, implantation rate, clinical pregnancy rate and miscarriage rate. In addition, we performed a systematic review of existing studies on the safety of COVID-19 vaccination in women undergoing ART treatment. Results: In our study, 268 women received inactivated or recombinant COVID-19 vaccination and 268 controls were enrolled based on propensity score matching. We observed a decreased fertilization rate and signs for impaired oocyte maturation in vaccinated women. Besides our study, there were 15 studies analyzing the safety of COVID-19 vaccination in women undergoing ART treatment. For the mRNA vaccines, no adverse signals were reported concerning oocyte maturation, fertilization rate, blastulation rate, implantation rate, clinical pregnancy rate and miscarriage rate. In women being vaccinated with an inactivated vaccine, implantation rate, clinical pregnancy rate and miscarriage rate were not affected, whereas oocyte maturation and fertilization rate were impaired. Conclusions: Vaccination against COVID-19 in women undergoing ART treatment seems to be safe especially for women getting mRNA vaccines. The effects on oocyte maturation and fertilization rate of inactivated and recombinant COVID-19 vaccinations might be a safety signal and need further investigation and independent confirmation.

Risk factors for and pregnancy outcomes after SARS-CoV-2 in pregnancy according to disease severity: A nationwide cohort study with validation of the SARS-CoV-2 diagnosis.

INTRODUCTION: We identified risk factors and outcomes associated with SARS-CoV-2 infection in pregnancy in a universally tested population according to disease severity and validated information on SARS-CoV-2 during pregnancy in national health registers in Denmark. MATERIAL AND METHODS: Cohort study using data from national registers and medical records including all pregnancies between March 1, 2020 and February 28, 2021. We compared women with a validated positive SARS-CoV-2 test during pregnancy with non-infected pregnant women. Risk factors and pregnancy outcomes were assessed by Poisson and Cox regression models and stratified according to disease severity defined by hospital admission status and admission reason (COVID-19 symptoms or other). Using medical record data on actual period of pregnancy, we calculated predictive values of the SARS-CoV-2 diagnosis in pregnancy in the registers. RESULTS: SARS-CoV-2 infection was detected in 1819 (1.6%) of 111 185 pregnancies. Asthma was associated with infection (relative risk [RR] 1.63, 95% confidence interval [CI] 1.28-2.07). Risk factors for severe COVID-19 disease requiring hospital admission were high body mass index (median ratio 1.06, 95% CI 1.04-1.09), asthma (RR 7.47, 95% CI 3.51-15.90) and gestational age at the time of infection (gestational age 28-36 vs < 22: RR 3.53, 95% CI 1.75-7.10). SARS-CoV-2-infected women more frequently had hypertensive disorders in pregnancy (adjusted hazard ratio [aHR] 1.31, 95% CI 1.04-1.64), early pregnancy loss (aHR 1.37, 95% CI 1.00-1.88), preterm delivery before gestational age 28 (aHR 2.31, 95% CI 1.01-5.26), iatrogenically preterm delivery before gestational age 37 (aHR 1.49, 95% CI 1.01-2.19) and small-for-gestational age children (aHR 1.28, 95% CI 1.05-1.54). The associations were stronger among women admitted to hospital for any reason. The validity of the SARS-CoV-2 diagnosis in relation to pregnancy in the registers compared with medical records showed a negative predictive value of 99.9 (95% CI 99.9-100.0) and a positive predictive value of 82.1 (95% CI 80.4-83.7). CONCLUSIONS: Women infected with SARS-CoV-2 during pregnancy were at increased risk of hypertensive disorders in pregnancy, early pregnancy loss, preterm delivery and having children small for gestational age. The validity of Danish national registers was acceptable for identification of SARS-CoV-2 infection during pregnancy.