Impact of COVID-19 and vaccination on first and second trimester screening results.

COVID-19 has been shown to affect pregnant women. Since pregnant women are at risk of this infection, vaccination against COVID-19 has been suggested as an imperative way to diminish rate of COVID-19 in this population. In the current observational study, we have collected data of first and second trimester screening (FTS and STS) from pregnant women who were infected with SARS-CoV-2 and/or vaccinated against COVID-19 during their pregnancy, and compared this data with a group of control pregnant women. The cohort included 4612 and 2426 women referred for FTS and STS, respectively. There was no significant difference in median values of Pregnancy-associated plasma protein A (PAPP-A) and human chorionic gonadotropin-beta subunit (ßHCG) between infected women and controls. Moreover, these levels were not different between "Infected + vaccinated" and "Only vaccinated" groups. However, median values of PAPP-A and ßHCG were higher in "Infected + vaccinated" and "Only vaccinated" groups compared with "Infected" and "Control" groups (P < 0.001). Median values of unconjugated Estriol (uE3) and ßHCG markers were not different between "Only vaccinated" and "Control" groups, yet both markers were elevated in "Infected" and "Infected + vaccinated" groups compared with other groups. AFP values were higher in "Infected" group (P = 0.012). However, multiple of the median (MoM) and risk of open spina bifida (OSB) were not affected. Finally, median of calculated risk of trisomy 18 was lower in "Infected" and "Vaccinated" groups compared with controls (P = 0.007). Moreover, AstraZeneca and Sinopharm vaccines were associated with elevation of the calculated risk values of trisomy 21 and trisomy 18 (P < 0.001). While Sinopharm did not affect nuchal translucency (NT) and NT MoM (P = 0.13), AstraZeneca and Barakat increased and decreased these values, respectively (P values = 0.0027 and 0.015, respectively). Taken together, COVID-19 during pregnancy might be associated with some adverse obstetric outcomes. Besides, vaccination against this infection might affect the results of STS or FTS.

Decision-making process about prenatal genetic screening: how deeply do moms-to-be want to know from Non-Invasive Prenatal Testing?

BACKGROUND: Prenatal information may be obtained through invasive diagnostic procedures and non-invasive screening procedures. Several psychological factors are involved in the decision to undergo a non-invasive prenatal testing (NIPT) but little is known about the decision-making strategies involved in choosing a specific level of in-depth NIPT, considering the increased availability and complexity of NIPT options. The main aim of this work is to assess the impact of psychological factors (anxiety about pregnancy, perception of risk in pregnancy, intolerance to uncertainty), and COVID-19 pandemic on the type of NIPT chosen, in terms of the number of conditions that are tested. METHODS: A self-administered survey evaluated the decision-making process about NIPT. The final sample comprised 191 women (Mage = 35.53; SD = 4.79) who underwent a NIPT from one private Italian genetic company. Based on the test date, the sample of women was divided between "NIPT before COVID-19" and "NIPT during COVID-19". RESULTS: Almost all of the participants reported being aware of the existence of different types of NIPT and more than half reported having been informed by their gynecologist. Results showed no significant association between the period in which women underwent NIPT (before COVID-19 or during COVID-19) and the preferences for more expanded screening panel. Furthermore, regarding psychological variables, results showed a significant difference between perceived risk for the fetus based on the NIPT type groups, revealing that pregnant women who underwent the more expanded panel had a significantly higher level of perceived risk for the fetus than that reported by pregnant women who underwent the basic one. There was no statistically significant difference between the other psychological variables and NIPT type. CONCLUSIONS: Our findings indicate the paramount role of gynecologist and other health care providers, such as geneticists and psychologists, is to support decision-making process in NIPT, in order to overcome people's deficits in genetic knowledge, promote awareness about their preferences, and control anxiety related to the unborn child. Decision-support strategies are critical during the onset of prenatal care, according to the advances in prenatal genomics and to parent's needs.

A dPCR-NIPT assay for detections of trisomies 21, 18 and 13 in a single-tube reaction-could it replace serum biochemical tests as a primary maternal plasma screening tool?

BACKGROUND: The next generation sequencing (NGS) based non-invasive prenatal test (NIPT) has outplayed the traditional serum biochemical tests (SBT) in screen of fetal aneuploidies with a high sensitivity and specificity. However, it has not been widely used as a primary screen tool due to its high cost and the cheaper SBT is still the choice for primary screen even with well-known shortages in sensitivity and specificity. Here, we report a multiplex droplet digital PCR NIPT (dPCR-NIPT) assay that can detect trisomies 21, 18 and 13 (T21, T18 and T13) in a single tube reaction with a better sensitivity and specificity than the SBT and a much cheaper price than the NGS-NIPT. METHODS: In this study, the dPCR-NIPT assay's non-clinical characteristics were evaluated to verify the cell free fetal DNA (cffDNA) fraction enrichment efficiencies, the target cell free DNA (cfDNA) concentration enrichment, the analytical sensitivity, and the sample quality control on the minimum concentration of cfDNA required for the assay. We validated the clinical performance for this assay by blindly testing 283 clinical maternal plasma samples, including 36 trisomic positive samples, from high risk pregnancies to access its sensitivity and specificity. The cost effectiveness of using the dPCR-NIPT assay as the primary screen tool was also analyzed and compared to that of the existing contingent strategy (CS) using the SBT as the primary screen tool and the strategy of NGS-NIPT as the first-tier screen tool in a simulating situation. RESULTS: For the non-clinical characteristics, the sample processing reagents could enrich the cffDNA fraction by around 2 folds, and the analytical sensitivity showed that the assay was able to detect trisomies at a cffDNA fraction as low as 5% and the extracted cfDNA concentration as low as 0.2 ng/µL. By testing the 283 clinical samples, the dPCR-NIPT assay demonstrated a detection sensitivity of 100% and a specificity of 95.12%. Compared to the existing CS and the NGS-NIPT as the first-tier screen strategy, dPCR-NIPT assay used as a primary screen tool followed by the NGS-NIPT rescreen is the most economical approach to screen pregnant women for fetal aneuploidies without sacrificing the positive detection rate. CONCLUSION: This is the first report on a dPCR-NIPT assay, consisting of all the necessary reagents from sample processing to multiplex dPCR amplification, can detect T21, T18 and T13 in a single tube reaction. The study results reveal that this assay has a sensitivity and specificity superior to the SBT and a cost much lower than the NGS-NIPT. Thus, from both the test performance and the economic benefit points of views, using the dPCR-NIPT assay to replace the SBT as a primary screen tool followed by the NGS-NIPT rescreen would be a better approach than the existing CS for detection of fetal aneuploidies in maternal plasma.

Antenatal screening of depressive and manic symptoms in south Brazilian childbearing women: A transversal study in advance of the pandemic scenario.

BACKGROUND: The diagnosis of mood disorders (MD) during pregnancy is challenging and may bring negative consequences to the maternal-fetal binomial. The long waitlist for specialized psychiatric evaluation in Brazil contributes to the treatment omission. Almost 20.0% of women treated with antidepressants have a positive screening for bipolar disorder. Therefore, it has been recommended the investigation of depressive and bipolar disorder during prenatal care. Unfortunately, the screening for mood disorders is not a reality in Brazil and many childbearing women remain undiagnosed. The objective of this study is to observe the frequency of MD and the effectiveness of screening scales for routine use by health professionals during prenatal care in high-risk pregnancies. METHODOLOGY/PRINCIPAL FINDINGS: This cross-sectional study included 61 childbearing women in their second trimester who were interviewed using the Edinburgh Postnatal Depression Scale (EPDS) and the Mood Disorder Questionnaire (MDQ). The cut-off point was EPDS ≥ 13 and MDQ ≥ 7 and the SCID-5 was the gold standard diagnosis. MD were diagnosed in 24.6% of the high-risk pregnancies. EDPS was positive in 19.7% and the frequency of major depression was 8.2%. 16.4% of the childbearing women were diagnosed with bipolar disorder, while MDQ was positive in 36.1%. 11.5% of the women had EPDS and MDQ positive. EPDS sensitivity was 80.0% and specificity 92.1%, whereas MDQ presented a sensitivity of 70.0% and specificity of 70.6%. CONCLUSION/SIGNIFICANCE: There is a high prevalence of MD in high-risk pregnancies. The routine use of EPDS simultaneously to MDQ during antenatal care is effective and plays an important role in early diagnosis, counselling, and promotion of perinatal mental health.

Screening and Testing Pregnant Patients for SARS-CoV-2: First-Wave Experience of a Designated COVID-19 Hospitalization Centre in Montréal.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) may present asymptomatically in a large proportion of cases in endemic areas. Accordingly, universal testing has been suggested as a potential strategy for reducing transmission in the obstetrical setting. We describe the clinical characteristics of patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy at a designated COVID-19 hospitalization centre in Montréal, Québec. METHODS: A single-centre retrospective cohort was constructed to include all pregnant patients who tested positive for SARS-CoV-2 between March 22 and July 31, 2020, and received care at the Jewish General Hospital. Initially, testing was restricted to at-risk patients, identified through the use of a screening questionnaire. Beginning on May 15, 2020, universal testing was implemented, and all pregnant patients admitted to the hospital were tested. Data were collected through chart review. RESULTS: Of 803 patients tested for SARS-CoV-2 during the study period, 41 (5%) tested positive. Among those patients who were symptomatic, the most commonly reported symptoms were cough (53%), fever (37%), dyspnea (30%), and anosmia and/or ageusia (20%). Before the implementation of universal testing, 13% (3 of 24) of patients with SARS-CoV-2 were asymptomatic. After implementation of universal testing, 80% (8 of 10) of patients with SARS-CoV-2 were asymptomatic. CONCLUSION: Our findings suggest that most pregnant patients with SARS-CoV-2 are asymptomatic or have mild symptoms of COVID-19. Particularly in endemic areas, universal testing of pregnant patients presenting to the hospital should be strongly considered as an important measure to prevent in-hospital and community transmission of COVID-19.

Options for screening for gestational diabetes mellitus during the SARS-CoV-2 pandemic.

The balance between avoiding severe acute respiratory syndrome coronavirus-2 contagion and reducing wider clinical risk is unclear for gestational diabetes mellitus (GDM) testing. Recent recommendations promote diagnostic approaches that limit collection but increase undiagnosed GDM, which potentially increases adverse pregnancy outcome risks. The most sensitive approach to detecting GDM at 24-28 weeks beyond the two-hour oral glucose tolerance test (OGTT) is a one-hour OGTT (88% sensitivity). Less sensitive approaches use fasting glucose alone (≥5.1 mmol/L: misses 44-54% GDM) or asking ~20% of women for a second visit (fasting glucose 4.7-5.0 mmol/L (62-72% sensitive)). Choices should emphasise local and patient decision-making.

The rate of SARS-CoV-2 positivity in asymptomatic pregnant women admitted to hospital for delivery: Experience of a pandemic center in Turkey.

OBJECTIVE: To investigate the rate of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity in asymptomatic pregnant women admitted to hospital for delivery in a Turkish pandemic center. STUDY DESIGN: This prospective cohort study was conducted in Ankara City Hospital between April, 15, 2020 and June, 5, 2020. A total of 206 asymptomatic pregnant women (103 low-risk pregnant women without any defined risk factor and 103 high-risk pregnant women) were screened for SARS-CoV-2 positivity upon admission to hospital for delivery. Detection of SARS-CoV2 in nasopharyngeal and oropharyngeal samples was performed by Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) method targeting RdRp (RNA dependent RNA polymerase) gene. Two groups were compared in terms of demographic features, clinical characteristics and SARS-CoV-2 positivity. RESULTS: Three of the 206 pregnant women participating in the study had positive RT-PCR tests (1.4 %) and all positive cases were in the high-risk pregnancy group. Although, one case in the high-risk pregnancy group had developed symptoms highly suspicious for COVID-19, two repeated RT-PCR tests were negative. SARS-CoV-2 RT-PCR positivity rate was significantly higher in the high-risk pregnancy group (2.9 % vs 0%, p = 0.04). CONCLUSION: Healthcare professionals should be cautious in the labor and delivery of high-risk pregnant women during the pandemic period and universal testing for COVID-19 may be considered in selected populations.

Universal screening for SARS-CoV-2 in pregnant women at term admitted to an East London maternity unit.

OBJECTIVE: To explore the prevalence of asymptomatic SARS-CoV-2 in the maternity population. STUDY DESIGN: Newham University Hospital based in East London serving a population with the highest death rate secondary to SARS-CoV-2 in the UK, commenced universal screening of all admissions to the Maternity Unit from 22nd April to 5th May, 2020. A proforma was created to capture key patient demographics, indication for admission and presence of SARS-CoV-2 related symptoms at the point of presentation. RESULTS: A total of 180 women with a mean age of 29.9 (SD 7.4) years, at a median gestation of 39 (IQR 37 + 1-40 + 3) weeks underwent universal screening with nasopharyngeal PCR swabs during the two-week period of the study. BAME identity or parity was not associated with the likelihood of a positive result. Seven women (3.9 %, 1.6-7.8) were tested positive for SARS-CoV-2, of whom 6 (3.3 %, 1.2-7.1) were asymptomatic; 85.7 % (42.1-99.6) of the SARS-CoV-2 positive women were asymptomatic. The sensitivity of symptom-driven testing was 14.3 % (0.36-57.87) and specificity was 91.86 % (86.72-95.48) with a positive predictive value of 6.67 % (1.08-31.95) and a negative predictive value of 96.34 % (95.10-97.28). CONCLUSION: The prevalence of SARS-CoV-2 in the maternity population served by Newham University Hospital was 3.9 %, four weeks after lockdown. Of the women who were found to be SARS-CoV-2 positive, a high proportion (87.9 %) were asymptomatic. These findings support the need for universal testing to enable targeted isolation and robust infectious control measures to mitigate outbreaks of SARS-CoV-2 in maternity units.

Prenatal screening diagnosis and management in the era of coronavirus: the Sardinian experience.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a new coronavirus, was first identified in December 2019 in Wuhan, China and spread rapidly, affecting many other countries. The disease is now referred to as coronavirus disease 2019 (COVID-19).The Italian government declared a state of emergency on 31st January 2020 and on 11th March World Health Organization (WHO) officially declared the COVID-19 outbreak a global pandemic. Although the COVID-19 incidence remained considerably lower in Sardinia than in the North Italy regions, which were the most affected, the field of prenatal screening and diagnosis was modified because of the emerging pandemic. Data on COVID-19 during pregnancy are so far limited. Since the beginning of the emergency, our Ob/Gyn Department at Microcitemico Hospital, Cagliari offered to pregnant patients all procedures considered essential by the Italian Ministry of Health. To evaluate the influence of the COVID-19 pandemic on the activities of our center, we compared the number of procedures performed from 10th March to 18th May 2020 with those of 2019. Despite the continuous local birth rate decline, during the 10-week pandemic period, we registered a 20% increment of 1st trimester combined screening and a slight rise of the number of invasive prenatal procedures with a further increase in chorionic villi sampling compared to amniocentesis. Noninvasive prenatal testing remained unvariated. The request for multifetal pregnancy reduction as a part of the growing tendency of voluntary termination of pregnancy in Sardinia increased. The COVID-19 pandemic provides many scientific opportunities for clinical research and study of psychological and ethical issues in pregnant women.

Making the most of the first prenatal visit: The challenge of expanding prenatal genetic testing options and limited clinical encounter time.

OBJECTIVE: Advances in prenatal genetics place additional challenges as patients must receive information about a growing array of screening and testing options. This raises concerns about how to achieve a shared decision-making process that prepares patients to make an informed decision about their choices about prenatal genetic screening and testing options, calling for a reconsideration of how healthcare providers approach the first prenatal visit. METHODS: We conducted interviews with 40 pregnant women to identify components of decision-making regarding prenatal genetic screens and tests at this visit. Analysis was approached using grounded theory. RESULTS: Participants brought distinct notions of risk to the visit, including skewed perceptions of baseline risk for a fetal genetic condition and the implications of screening and testing. Participants were very concerned about financial considerations associated with these options, ranking out-of-pocket costs on par with medical considerations. Participants noted diverging priorities at the first visit from those of their healthcare provider, leading to barriers to shared decision-making regarding screening and testing during this visit. CONCLUSION: Research is needed to determine how to restructure the initiation of prenatal care in a way that best positions patients to make informed decisions about prenatal genetic screens and tests.

Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic.

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical scenarios, and services: (1) hypertensive disorders of pregnancy including preeclampsia, gestational hypertension, and chronic hypertension; (2) pregestational and gestational diabetes mellitus; (3) maternal cardiovascular disease; (4) maternal neurologic conditions; (5) history of preterm birth and poor obstetrical history including prior stillbirth; (6) fetal conditions such as intrauterine growth restriction, congenital anomalies, and multiple gestations including monochorionic placentation; (7) genetic counseling; (8) mental health services; (9) obstetric anesthesia consultations; and (10) postpartum care. While telehealth virtual visits do not fully replace in-person encounters during prenatal care, they do offer a means of reducing potential patient and provider exposure to COVID-19 while providing consolidated in-person testing and services. KEY POINTS: · Telehealth for prenatal care is feasible.. · Telehealth may reduce coronavirus exposure during prenatal care.. · Telehealth should be tailored for high risk prenatal patients..