Evaluating COVID-19 vaccine effectiveness during pre-Delta, Delta and Omicron dominant periods among pregnant people in the U.S.: Retrospective cohort analysis from a nationally sampled cohort in National COVID Collaborative Cohort (N3C).

Objectives: To evaluate the effectiveness of COVID-19 vaccinations (initial and booster) during pre-Delta, Delta, and Omicron dominant periods among pregnant people via (1) COVID-19 incident and severe infections among pregnant people who were vaccinated vs. unvaccinated and (2) post-COVID-19 vaccination breakthrough infections and severe infections among vaccinated females who were pregnant vs. non-pregnant. Design: Retrospective cohort study using nationally sampled electronic health records data from the National COVID Cohort Collaborative (N3C), December 10, 2020, to June 07, 2022. Participants: Cohort 1 included pregnant people (15-55 years), and Cohort 2 included vaccinated females of reproductive age (15-55 years). Exposures: (1) COVID-19 vaccination and (2) pregnancy. Main outcome measures: Adjusted hazard ratios (aHRs) for COVID-19 incident or breakthrough infections and severe infections (i.e., COVID-19 infections with related hospitalizations). Results: In Cohort 1, 301,107 pregnant people were included. Compared to unvaccinated pregnant people, the aHRs for pregnant people with initial vaccinations during pregnancy of incident COVID-19 were 0.77 (95% CI: 0.62, 0.96) and 0.88 (95%CI: 0.73, 1.07) and aHRs of severe COVID-19 infections were 0.65 (95% CI: 0.47, 0.90) and 0.79 (95% CI: 0.51, 1.21) during the Delta and Omicron periods, respectively. Compared to pregnant people with full initial vaccinations, the aHR of incident COVID-19 for pregnant people with booster vaccinations was 0.64 (95% CI: 0.58, 0.71) during the Omicron period. In Cohort 2, 934,337 vaccinated people were included. Compared to vaccinated non-pregnant females, the aHRs of severe COVID-19 infections for people with initial vaccinations during pregnancy was 2.71 (95% CI: 1.31, 5.60) during the Omicron periods. Conclusions: Pregnant people with initial and booster vaccinations during pregnancy had a lower risk of incident and severe COVID-19 infections compared to unvaccinated pregnant people across the pandemic stages. However, vaccinated pregnant people still had a higher risk of severe infections compared to non-pregnant females.

A latent class analysis of factors influencing preferences for infant respiratory syncytial virus (RSV) preventives among pregnant people in the United States.

A maternal vaccine and long-acting monoclonal antibody (mAb) were recently approved to protect infants against respiratory syncytial virus (RSV). We identified subgroups of pregnant people with different preferences for RSV preventives and respondent characteristics associated with subgroup membership. An online survey, including a discrete choice experiment (DCE), was conducted among US pregnant people. RSV preventive attributes included effectiveness, duration of protection during RSV season, injection recipient/timing, preventive type (vaccine or mAb), and type of visit required to receive injection. In DCE choice tasks, pregnant people selected between two hypothetical preventive profiles with varying attribute-levels and a no-preventive option. Logistic regression, including latent class analysis (LCA), was used to analyze the data. Of 992 pregnant people (mean age: 30.0 years), 60.3% were expecting their second/later birth. LCA identified three preference subgroups: 'Effectiveness' (preventive choice mostly driven by increases in effectiveness; 51.4% class membership probability), 'Season' (preventive choice mostly driven by improvement in duration of protection during the RSV season; 39.2% class membership probability), and 'No Preventive' (frequently chose no-preventive option; 9.4% class membership probability). 'Effectiveness' and 'Season' preferred maternal vaccine over mAb; mAb was preferred by 'No Preventive.' Perceiving RSV as serious for infants, higher health literacy, and lower household income were associated with 'Effectiveness.' Perceiving RSV as serious for pregnant people was associated with 'Season.' Perceiving RSV to not be serious for pregnant people and not being employed were associated with 'No Preventive.' Subgroups of pregnant people vary in preferences for RSV preventives. Most pregnant people preferred a maternal vaccine, although some may be more willing to accept alternative preventive options.

Healthcare Providers' and Pregnant People's Preferences for a Preventive to Protect Infants from Serious Illness Due to Respiratory Syncytial Virus.

We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were recruited via convenience sample from a general research panel to complete a cross-sectional, web-based survey, including a discrete choice experiment (DCE) wherein respondents chose between hypothetical RSV preventive profiles varying on five attributes (effectiveness, preventive type [maternal vaccine vs. mAb], injection recipient/timing, type of medical visit required to receive the injection, and duration of protection during RSV season) and a no-preventive option. A best-worst scaling (BWS) exercise was included to explore the impact of additional attributes on preventive preferences. Data were collected between October and November 2022. Attribute-level preference weights and relative importance (RI) were estimated. Overall, 992 pregnant people and 310 HCPs participated. A preventive (vs. none) was chosen 89.2% (pregnant people) and 96.0% (HCPs) of the time (DCE). Effectiveness was most important to preventive choice for pregnant people (RI = 48.0%) and HCPs (RI = 41.7%); all else equal, pregnant people (RI = 5.5%) and HCPs (RI = 7.2%) preferred the maternal vaccine over mAbs, although preventive type had limited influence on choice. Longer protection, protection starting at birth or the beginning of RSV season, and use for both pre-term and full-term babies were ranked highest in importance (BWS). Pregnant people and HCPs strongly preferred a preventive to protect infants against RSV (vs. none), underscoring the need to incorporate RSV preventives into routine care.

Risk factors related to the SARS-CoV-2 vaccine additional doses hesitancy among pregnant and non-pregnant people of reproductive age and partners: A Brazilian cross-sectional study.

OBJECTIVE: The aim of this study was to assess the predictors of acceptance and hesitancy of additional doses of any SARS-CoV-2 (COVID-19) vaccine among pregnant or recently pregnant and non-pregnant people of reproductive age and partners in Brazil. METHODS: We conducted an online cross-sectional study from June 2022 to April 2023 and invited women and partners between 18 and 49 years old to participate. We employed a snowball strategy to reach all potential eligible participants. Our primary outcome was the acceptance rate of the COVID-19 booster vaccine. We estimated the frequency and percentage for the three groups and compared categorical variables using the Chi-square test. Moreover, bivariate, backward stepwise regression, and subgroup analyses were performed to evaluate risk factors and predictors of COVID-19 vaccine booster hesitancy. We reported the effect size as OR with a 95% CI. RESULTS: We included 1487 participants, and among them, 334 (22.5%) were pregnant or recently pregnant people, 905 (60.8%) were non-pregnant people, and 247 (16.6%) were male partners. Pregnant and recently pregnant people showed greater hesitancy for the COVID-19 vaccine booster than non-pregnant people (28% vs 15%, P < 0.001) and male partners (28% vs 16%, P < 0.001). Non-pregnant women accepted the COVID-19 vaccine more often than pregnant or recently pregnant people (OR 1.75; 95% CI: 1.13-2.70). The associated factors to the reduced COVID-19 vaccine booster acceptance were family income between US$ 566-945.00 (54%), evangelic religion (65%), concern about vaccine safety (80%) and perceived common vaccine importance (93%). CONCLUSION: Pregnant people were more hesitant than non-pregnant people to accept the COVID-19 booster vaccine. Family income, religious beliefs, vaccine safety concerns, and perceived common vaccine importance were significant barriers to accepting COVID-19 booster vaccines. The impact of these factors was more evident among pregnant or recently pregnant people, emphasizing the harmful effect of misinformation among this vulnerable population.

Stress During Pregnancy Associated with Newborn Low Birth Weight: Experiences from the State of Rhode Island.

PURPOSE: Prenatal stress is a known risk for poor birth outcomes. This study specifically looked at reported stress during pregnancy and low birth weight (LBW) in Rhode Island. METHODS: Pregnancy Risk Assessment Monitoring System (PRAMS) data from 2016 to 2018 for the state of Rhode Island was utilized. Stress during most recent pregnancy was dichotomized as: 'none to minimal' and 'moderate to high.' LBW was defined as less than 2,500 g. Multivariable regression analysis was performed, accounting for complex survey design. RESULTS: In this cohort, 24% of pregnant people reported moderate to high stress leading to an adjusted odds of 1.70 (95% CI 1.43-2.03) of having a LBW newborn compared to those with none to minimal stress. Primiparity, previous preterm birth, racism, smoking history, and history of chronic medical problems were also associated with LBW newborns. CONCLUSION: We recommend screening and provision of support services for stress in all settings where pregnant people access care.

What is prenatal stress? A scoping review of how prenatal stress is defined and measured within the context of food insecurity, housing instability, and immigration in the United States.

BACKGROUND: Stress during pregnancy can lead to significant adverse outcomes for maternal mental health. Early evaluation of prenatal stress can help identify treatment needs and appropriate interventions. Disparities in the social determinants of health can contribute to stress, but what constitutes stress during pregnancy within the social determinants of health framework is poorly understood. OBJECTIVE: To scope how prenatal stress is defined and measured among pregnant people exposed to three prominent social stressors in the United States: insecurity pertaining to food, housing, and immigration. ELIGIBILITY CRITERIA: We included all studies that focused on stress during pregnancy in the context of food insecurity, housing instability, and immigration, given their recent policy focus due to the COVID-19 pandemic and ongoing political discourse, in addition to their importance in American College of Obstetricians and Gynecologists (ACOG's) social determinants of health screening tool. SOURCES OF EVIDENCE: We searched PubMed, Scopus, and Web of Science for articles published between January 2012 and January 2022. CHARTING METHODS: Using a piloted charting tool, we extracted relevant study information from the selected articles and analyzed the content pertaining to stress. RESULTS: An initial search identified 1,023 articles, of which 24 met our inclusion criteria. None of the studies defined prenatal stress, and only one used the Prenatal Distress Questionnaire, a prenatal stress-specific tool to measure it. The Perceived Stress Scale was the most common instrument used in seven studies. Fifteen studies measured over 25 alternative exposures that researchers theorized were associated with stress, and 4 of the 15 studies did not explain the association between the measure and stress. CONCLUSIONS: Our findings demonstrate a fundamental inconsistency in how prenatal stress is defined and measured in the context of social determinants of health, limiting the comparison of results across studies and the potential development of effective interventions to promote better maternal mental health.

Comparing the factor structures and reliabilities of the EPDS and the PHQ-9 for screening antepartum and postpartum depression: a multigroup confirmatory factor analysis.

To evaluate and compare the factor structure and reliability of EPDS and PHQ in antepartum and postpartum samples. Parallel analysis and exploratory factor analysis were conducted to determine the structure of both scales in the entire sample as well as in the antepartum and postpartum groups. McDonald's omega statistics examined the utility of treating items as a single scale versus multiple factors. Multigroup confirmatory factor analysis (MCFA) was utilized to test the measurement invariance between the antepartum and postpartum groups. Two-factor models fit best for the EPDS in both the antepartum and postpartum groups; however, the most reliable score variance was attributable to a general factor for each scale. MCFA provided evidence of weak invariance across groups regarding factor loadings and partial invariance regarding item thresholds. PHQ-9 showed a two-factor model in the antepartum group; however, the same model did not fit well in the postpartum group. EPDS should be preferred to PHQ-9 for measuring depressive symptoms in peripartum populations. Both scales should be used as a single-factor scale. Caution is required when comparing the antepartum and postpartum scores.

Stimulating solidarity to improve knowledge on medications used during pregnancy : A contribution from the ConcePTION project.

BACKGROUND: Pregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing the evidence gap. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy. METHOD: We use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication. RESULTS: Solidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy. CONCLUSIONS: We conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications.

A qualitative exploration of the eight dimensions of wellness in opioid use disorder recovery during the postpartum period.

Background: Recovery from opioid use disorder (OUD) during the perinatal period has unique challenges. We examined services for perinatal women with OUD using the Substance Abuse and Mental Health Services Administration (SAMHSA) eight dimensions of wellness (DoW), which reflect whole person recovery. Methods: We enrolled professionals from the Southwestern United States who work with people with OUD during the perinatal period. Semi-structured in-depth interviews were conducted from April to December 2020. Participants were shown the DoW diagram (emotional, social, environmental, physical, financial, spiritual, occupational, intellectual) and asked to share how their clinic/agency addresses each DoW for perinatal people with OUD. Responses were transcribed and coded by two researchers using Dedoose software. Results: Thematic analysis revealed ways professionals (n = 11) see how the services they provide fit into the DoW. This included: the need to provide mothers emotional support with a nonjudgmental approach, groups providing social support; guidance on nutrition, self-care, and a focus on the mother/infant dyad; assistance with employment and activities of daily living; parenting education; connecting mothers with resources and grants; providing a variety of spiritual approaches depending on the desire of the mother; and navigating the interpersonal environment as well as the physical space. Conclusions: There are opportunities to expand the treatment and services provided to women with OUD during the perinatal period within all eight DoWs. Additional research is needed to identify effective strategies to incorporate these components into patient-centered, holistic care approaches.

Being Pregnant during COVID-19: Exploring the COVID-19 Related Beliefs, Behaviors, and Birth Outcome among Users of a Pregnancy App.

Being pregnant during COVID-19 increases the risk of experiencing severe COVID-19 symptoms, which in turn increases the risk of complications. This study aimed to examine COVID-19-related beliefs, behaviors, and birth outcomes among users of Count the Kicks (CTK), a fetal movement tracking app. This study used the End of Pregnancy Survey data from 1037 CTK users. We used descriptive analyses to analyze COVID-19-related beliefs and behaviors and used the chi-square statistic and Z statistic to examine factors associated with vaccination and birth outcome. Nearly half of the survey respondents reported not being concerned that in-person prenatal visits might lead to COVID-19 exposure. Most respondents (65.9%) had already received the COVID-19 vaccine at the time of the survey. The vaccination rate was statistically significantly lower among African Americans than the remaining race/ethnicity groups (mostly white). The healthy birth rate is lower among respondents with high-risk pregnancies, while the stillbirth rate is highest among Hispanics. Vaccination status was not associated with the likelihood of a healthy birth. Our findings confirmed that vaccination does not compromise birth outcomes, further contributing to the existing evidence of COVID vaccine safety during pregnancy. This study also demonstrates an example of using data from a pregnancy app to facilitate research on app users in real-time.

Association between U.S. state prenatal drug use laws and child welfare reporting in Alabama, Maryland and Utah.

BACKGROUND: Over the past decade, states have passed several laws on prenatal drug use, including "maltreatment laws" deeming prenatal drug use child maltreatment, "reporting laws" requiring providers to report prenatal drug use to Child Protective Services (CPS) and "criminalization laws" that criminalize prenatal drug use. METHOD: We examined the association between a 2012 Utah maltreatment law, a 2013 Alabama maltreatment and criminalization law, and a 2014 Maryland reporting law on the rate of infant CPS reports using 2010-2017 National Child Abuse and Neglect Data System data. We conducted an event study comparing CPS reporting pre/post law in each treatment state with reporting in a pool of control states over the same period. Regression models included state and year fixed effects and state-level demographics. We triangulated quantitative results with qualitative interviews of 11 state leaders whose professional responsibilities included implementation of the state law. RESULTS: We found no association between Alabama's simultaneous maltreatment and criminalization laws and infant reporting. Maryland's reporting law (28.2 fewer reports per 1000 infants, 95%CI: [-42.9, -13.6], 4-years post-law) and Utah's maltreatment laws (31.0 fewer CPS reports per 1000 infants, 95%CI: [-61.2, -0.8], 6-years post-law) were associated with declines in infant CPS reports. Qualitative results suggest that the reduced reporting associated with Maryland's reporting and Utah's maltreatment laws may be due to increased perceived stigma resulting from the law, and health providers' distrust of CPS and/or confusion about reporting to CPS. CONCLUSION: Future research should characterize differential policy implementation across states and counties and identify policy impacts on treatment seeking behavior.

Emphasizing mindfulness training in acceptance relieves anxiety and depression during pregnancy.

Mindfulness intervention, which trains participants to monitor momentary experiences with an accepting attitude, is effective for reducing maternal anxiety and depression. Monitoring and acceptance are two central components of mindfulness training. The aim of the study is to clarify whether adding acceptance component to monitoring training can help improve the mental health of pregnant people by comparing the effects between mindfulness training on monitoring with an emphasis on acceptance training and training on monitoring alone. Pregnant people with depressive or anxious symptoms (N = 149) were randomized to either a 4-week online intervention of (1) monitoring training (MT), (2) monitoring with an emphasis on acceptance training (MAT), or (3) emotional regulation course conditions as an active control group. All mindfulness training was based on the WeChat platform. We used the Generalized Anxiety Disorder Scale (GAD-7), Patient Health Questionnaire (PHQ-9), Five Facets of Mindfulness Questionnaire (FFMQ), and Regulatory Emotional Self-Efficacy Scale (RESE) to evaluate symptoms of anxiety and depression, mindfulness monitoring and acceptance skills, and the self-efficacy of emotional regulation pre-and postintervention. Of the 149 people enrolled in this study, 10 in the MT training group, 9 in the MAT group, and 15 in the control group did not complete the intervention. Monitoring with an emphasis on acceptance training significantly reduced symptoms of anxiety and depression and improved perceived self-efficacy in managing depression/distress compared with the monitoring training alone and the control group. In addition, participants in the monitoring group showed a downward trend in GAD-7 scores and an upward trend in scores of perceived self-efficacy in managing anger/irritation. This study not only shows that the 4-week online mindfulness training could be a promising technique to help people improve mental health; moreover, it provides evidence that emphasizing acceptance skills on mindfulness training may play a critical role because of its positive effects. We suggest that the online mindfulness intervention should be added as part of psychological care and recommend emphasizing acceptance training during pregnancy.

Phenylketonuria: Our Experience in Nine Years at a Tertiary-level Referral Institute.

INTRODUCTION: Phenyl ketonuria is an inborn error of amino acid metabolism resulting in excessive phenyl alanine levels in blood resulting in a spectrum of neurological defects. PATIENTS AND METHODS: We retrospectively went through the records of patients diagnosed as Phenyl ketonuria in the last nine years in our team and patients who's data could be accessed were analyzed in detail. Details of laboratory tests, imaging clinical features, course were recorded. OBSERVATION: A total of 32 patients were identified in nine years of which data was available only for 15 patients. Age at diagnosis varied from 2.5 years to 7 years. 73% were males. Global developmental delay, Microcephaly. Seizures blond hair, spasticity, regression, Ocular Hypertelorism, low set ears, Seborrhea, Hypotonia, Family history of mental retardation and Consanguinity was common one patient showed a large hypo pigmented area in left arm with eczematous rash. RESULTS OF LAB TESTS: Urine ferric chloride test and DNPH was positive in all cases. Tandem mass spectroscopy showed elevated phenyl alanine, normal tyrosine and elevated PHE tyrosine ratio in all cases. MRI showed symmetrical Flair hyperintensities in T2 weighted images in the parieto occipital region hypo on T1 with no diffusion restriction in 11 cases and MRS was normal. Genetic testing showed one non consanguineous family having carrier state. Follow up is from 1 year to 5 years. Seizures controlled in all. Regular fallow up shows change in hair color and gain of mile stones. There was no mortality. CONCLUSION: Phenyl ketonuria is a controllable metabolic disease. However there is considerable delay before diagnosis resulting in persistence of sequelae in children with PKU as well as normal children born to PKU mothers which needs attention to prevent these complications.