Effects of Prenatal Exposure to Second-Generation Antipsychotics on Development and Behavior Among Preschool-Aged Children: Preliminary Results From the National Pregnancy Registry for Psychiatric Medications.

Objective: Data are lacking on the neurodevelopmental outcomes of children prenatally exposed to second-generation antipsychotics (SGAs). The objective of this study is to examine neurodevelopmental outcomes of children exposed in utero to SGAs compared to those unexposed in a cohort of mothers with psychiatric morbidity.Methods: We conducted a cross-sectional assessment of preschool-aged children whose mothers were enrolled in the National Pregnancy Registry for Psychiatric Medications. Two validated, parent-report developmental and behavioral screening assessments, the Ages and Stages Questionnaire, Third Edition (ASQ-3) and the Preschool Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5), respectively, were delivered electronically to eligible participants. Outcomes of children exposed in utero to SGAs were compared to those unexposed to SGAs in a cohort of mothers with a history of psychiatric illness. Exposure to other psychotropic medications during pregnancy was not an exclusion criterion for either group.Results: From January 2, 2018, to February 2, 2021, 520 children were eligible, and 352 responses were collected (67.7%), including 178 children in the SGA-exposed group (mean age = 2.6 years) and 174 children in the unexposed comparison group (mean age = 2.1 years). No significant differences between groups were detected (OR = 1.24, 95% CI, 0.74-2.09) with respect to developmental outcomes assessed by the ASQ-3. Similarly, for behavioral outcomes, adjusted analysis showed no significant differences in odds of an abnormal "clinical" score on the CBCL/1½-5 composite scales.Conclusions: The current study is the first to examine neurobehavioral outcomes of preschool-aged children exposed prenatally to SGAs. No significant differences in overall development or behavior were detected in the exposed versus unexposed group. These preliminary findings are an important step in delineating neurodevelopmental effects of prenatal SGA exposure.

Barriers to care and treatment experiences among individuals with postpartum psychosis.

PURPOSE: Postpartum psychosis (PP) is a severe psychiatric disorder affecting 1-2 per 1,000 deliveries. Prompt access to healthcare and timely initiation of treatment are crucial to minimizing harm and improving outcomes. This analysis seeks to fill gaps in knowledge surrounding barriers to care and treatment experiences among this population. METHODS: Participants were individuals with histories of PP who enrolled in the Massachusetts General Hospital Postpartum Psychosis Project (MGHP3). The MGHP3 Healthcare Access Survey, a cross-sectional questionnaire, assesses barriers to care, treatment-seeking behaviors, and experiences with treatment. Descriptive statistics were utilized to describe sample characteristics. RESULTS: 139 participants provided 146 episode-specific survey responses. Lack of available services was cited as the greatest barrier to care for PP. Among those who sought treatment, obstetric providers (34.5%) and emergency medical professionals (29.4%) were the most common initial points of contact. 82.2% of the respondents went to an emergency room or crisis center during their episode(s). Most (61.8%) reported being given insufficient information to manage their PP. Approximately half of participants were hospitalized (55.5%), the majority of whom had no access to their infant during hospitalization (70.4%). Of those breastfeeding or pumping at admission, 31.3% were not given access to a breast pump. 44.4% dealt with delivery-related medical issues during their hospitalization. CONCLUSION: This report is the first of its kind to assess key public health domains among individuals with PP. Findings point to several directions for future research and clinical practice to improve treatment timeliness and quality, potentially improving long-term outcomes related to this serious illness.

Testing a Behavioral Activation Gaming App for Depression During Pregnancy: Multimethod Pilot Study.

BACKGROUND: Depression during pregnancy is increasingly recognized as a worldwide public health problem. If untreated, there can be detrimental outcomes for the mother and child. Anxiety is also often comorbid with depression. Although effective treatments exist, most women do not receive treatment. Technology is a mechanism to increase access to and engagement in mental health services. OBJECTIVE: The Guardians is a mobile app, grounded in behavioral activation principles, which seeks to leverage mobile game mechanics and in-game rewards to encourage user engagement. This study seeks to assess app satisfaction and engagement and to explore changes in clinical symptoms of depression and anxiety among a sample of pregnant women with elevated depressive symptoms. METHODS: This multimethod pilot test consisted of a single-arm, proof-of-concept trial to examine the feasibility and acceptability of The Guardians among a pregnant sample with depression (N=18). Participation included two web-based study visits: (1) a baseline assessment to collect demographic and obstetric information and to assess clinical symptoms and (2) an exit interview to administer follow-up measures and explore user experience. Participants completed biweekly questionnaires (ie, Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7) during the trial to assess depression and anxiety symptom severity. App satisfaction was measured using 2 self-report scales (ie, Mobile Application Rating Scale and Player Experience of Needs Satisfaction scale). Engagement with The Guardians was captured using game interaction metric data. We used backward-eliminated mixed effects longitudinal models to examine the effects of app engagement and satisfaction and length of time in the study on symptoms of depression and anxiety. Content analysis was conducted on qualitative data from exit interviews. RESULTS: The 15-day and 30-day overall app retention rates were 26.6% and 15.1%, respectively. Mixed effects models found significant negative main effects of week in study (ß=-.35; t61=-3.05; P=.003), number of activities completed (ß=-.12; t61=-2.05; P=.04), days played (ß=-.12; t58=-2.9; P=.005), and satisfaction, according to the Mobile Application Rating Scale (ß=-3.05; t45=-2.19; P=.03) on depressive symptoms. We have reported about similar analyses for anxiety. There is preliminary evidence suggesting harder activities are associated with greater mood improvement than easier activities. Qualitative content analysis resulted in feedback falling under the following themes: activities, app design, engagement, fit of the app with lifestyle, perceived impact of the app on mood, and suggestions for app modifications. CONCLUSIONS: Preliminary results from this multimethod study of The Guardians indicate feasibility and acceptability among pregnant women with depression. Retention and engagement levels were more than double those of previous public mental health apps, and use of the app was associated with significant decrease in depressive symptom scores over the 10-week trial. The Guardians shows promise as an effective and scalable digital intervention to support women experiencing depression.

The lived experiences of individuals with postpartum psychosis: A qualitative analysis.

Postpartum psychosis (PP) is a severe psychiatric illness that occurs in about 1 to 2 per 1000 people in the perinatal period. To date, qualitative research investigating PP has focused on specific topics, such as treatment experiences or the impact of the illness on patients' lives and families. These studies have included small samples of women with histories of PP, often limited to certain geographical areas or treatment centers. Given the heterogeneity in presentations of PP and access to care, larger and geographically diverse samples are needed to broadly understand this complex illness. Initiated in 2018, the Massachusetts General Hospital Postpartum Psychosis Project (MGHP3) consists of a large, international sample of those who have experienced PP. In addition to the specific aims of MGHP3, which include to better understand the phenomenology and potential genetic underpinnings of PP, this investigation invites participants to qualitatively describe their narratives of postpartum psychosis. This analysis included 130 participants who reported on 133 episodes of PP. Participants' responses to the PP narrative prompt fell under several overarching categories: 1) broad psychosocial experiences surrounding postpartum psychosis, 2) impact on the mother-baby dyad, 3) treatment experiences, and 4) recovery experiences. Our findings shed light on a range of ways in which individuals' lives are impacted by this illness, and point to areas for future research and clinical directions to improve the support and care for individuals with PP and their families.

Stressors and coping mechanisms among pregnant women with psychiatric disorders during the COVID-19 pandemic.

BACKGROUND: Women with psychiatric disorders are vulnerable to relapse in pregnancy, and the COVID-19 pandemic has presented an additional stressor. METHODS: Data came from a supplemental study offered to women enrolled in the Massachusetts General Hospital Center for Women's Mental Health National Pregnancy Registry for Psychiatric Medications. Registry participants were also invited to complete an email questionnaire relating to their experiences of pregnancy during the pandemic. Prepartum experiences of 230 respondents were analyzed. RESULTS: The most common diagnoses in this group were depression (30%), anxiety disorders (29%), and bipolar affective disorder (17%). Common stressors included changes in employment, greater childcare and/or schooling responsibilities, more conflict in the household, and increased isolation. Participants reported negative impacts and/or coping mechanisms associated with the pandemic, such as sleep problems, reduced physical activity, changes in eating, and greater amounts of screen time. Positive impacts and/or coping mechanisms were also reported, including more quality time with family, more time in nature, and being more appreciative of aspects of life previously taken for granted. CONCLUSIONS: Our findings suggest that the COVID-19 pandemic has had an overall negative psychosocial impact on many pregnant women with preexisting psychiatric disorders. We also observed positive coping mechanisms, which could be drawn on as sources of resilience.

Risk of Major Malformations in Infants After First-Trimester Exposure to Stimulants: Results From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

PURPOSE/BACKGROUND: The prevalence of attention-deficit/hyperactivity disorder in adult females is 3% to 4%. Attention-deficit/hyperactivity disorder is highly comorbid with other psychiatric disorders such as mood, anxiety, and substance use disorders. For reproductive-aged women, the treatment of attention-deficit/hyperactivity disorder with stimulant medications may be considered during pregnancy or breastfeeding, although historically, data are lacking to inform these decisions. The aim of this investigation was to determine the risk of major malformations in infants after first-trimester prescription stimulant exposure in a small but rigorously characterized sample. METHODS/PROCEDURES: The Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications systematically ascertains information from pregnant females including demographic information, medical and psychiatric history, use of prescription medications, and other information relevant to fetal outcomes. Participants provide verbal informed consent and are interviewed twice during gestation and again at approximately 3 months postpartum. The primary outcome of interest is the presence of a major malformation identified within 6 months after birth. Redacted cases of major malformations are reviewed by a dysmorphologist blinded to medication exposure. FINDINGS/RESULTS: A total of N = 1988 women were eligible for this analysis, including the following exposures: n = 173 to mixed amphetamine salts; n = 40 to lisdexamfetamine; n = 45 to methylphenidate; n = 3 to dexmethylphenidate; and n = 1755 controls. The odds ratio of a major malformation among infants after first-trimester exposure to any stimulant was 0.39 (95% confidence interval, 0.09-1.61) compared with controls. There were no major malformations observed in infants exposed to lisdexamfetamine, methylphenidate, or dexmethylphenidate. IMPLICATIONS/CONCLUSIONS: Although preliminary, this analysis from an ongoing pregnancy registry provides reassurance that these stimulants do not appear to have major teratogenic effects. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01246765 .

To screen or not to screen: Are we asking the right question? In response to considering de-implementation of universal perinatal depression screening.

This Editorial is a response to the Canadian Task Force on Preventive Health Care's recent recommendation "against instrument-based depression screening using a questionnaire with cut-off score to distinguish 'screen positive' and 'screen negative' administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth)." While we acknowledge the gaps and limitations in research on perinatal mental health screening, we have concerns regarding the potential impact of a recommendation against screening and for "de-implementation" of existing perinatal depression screening practices, particularly if there is not careful attention to the specificity as well as limitations of the recommendation, or if there are not clear alternative systems put in place to support the detection of perinatal depression. In this manuscript, we highlight some of our key concerns and suggest considerations for perinatal mental health practitioners and researchers.

The Challenge of Clinical Research and Suicidality: Participant Feedback on a Safety Protocol.

Objective: Clinical studies of depression have historically excluded participants with suicidal ideation. Research participant safety protocols are critical to allow for the much-needed study of suicide risk. This report summarizes participant feedback about the safety protocol used in a national, remote study of perinatal women with suicidal ideation.Methods: Upon completion of the study, participants who had triggered the suicidality safety protocol during the study were invited to complete a brief survey with questions about their experiences with the protocol. The survey included 4 Likert-scale questions and 1 open text question where participants could provide feedback, suggestions, and comments to the research team. Participant feedback survey data were collected between October 2021 and April 2022, and this research was funded by the National Institute of Mental Health.Results: Of the 45 participants enrolled in the UPWARD-S study, 16 triggered the safety protocol. All eligible participants (N = 16) completed the survey. Among respondents, most were at least neutral to very comfortable with the call from the study psychiatrist (75% [n = 12]) and reported that the call had a "positive impact" on their well-being (69% [n = 11]). After the call with the study psychiatrist, 50% of participants (n = 8) reported that they increased engagement with treatment for depression, and the other 50% reported no change in treatment. We also report on themes from the qualitative feedback regarding suggestions of how to modify or improve the safety protocol.Conclusions: Learning from the experiences of research participants will provide unique insight into satisfaction with, and impact of, the implemented suicidality safety protocol. Findings from this study could inform the refinement and implementation of safety protocols used in depression studies as well as future research on the impact of such protocols.

Persistent post-bariatric-surgery hypoglycemia: A long-term follow-up reassessment.

BACKGROUND AND AIM: Post-bariatric-surgery hypoglycemia (PBH) is a serious complication of bariatric surgery (BS). In our previous study about three quarters of the patients developed PBH. However long-term follow-up data is lacking to determine whether this condition improves with time. The aim of the current study was to re-assess post-BS patients who participated in our previous study and determine whether there are changes in the frequency and/or severity of hypoglycemic events. METHODS AND RESULTS: Twenty-four post-BS, post Roux-en-Y gastric-bypass (RYGB = 10), post omega-loop gastric-bypass (OLGB = 9) and post sleeve-gastrectomy (SG = 5) individuals were reevaluated in a follow-up study 34.4 ± 4 months after their previous assessment and 67 ± 17 months since surgery. The evaluation included: a dietitian assessment, a questionnaire, meal-tolerance test (MTT) and a one-week masked continuous glucose monitoring (CGM). Hypoglycemia and severe hypoglycemia were defined by glucose levels ≤54 mg/dl and ≤40 mg/dl, respectively. Thirteen patients reported questionnaire meal-related complaints, mainly non-specific. During MTT, hypoglycemia occurred in 75% of the patients, and severe hypoglycemia in a third, but none was associated with specific complaints. During CGM, 66% of patients developed hypoglycemia and 37% had severe hypoglycemia. We did not observe significant improvements in hypoglycemic events compared to the previous assessment. Despite the high frequency of hypoglycemia, it did not necessitate hospitalizations or lead to death. CONCLUSIONS: PBH did not resolve within long-term follow-up. Intriguingly, most patient were unaware of these events which can lead to underestimation by the medical staff. Further studies are needed to determine possible long term sequela of repeated hypoglycemia.

Prediabetes in pregnancy - follow-up, treatment, and outcomes compared to overt pregestational diabetes.

OBJECTIVE: There are limited data on follow-up, treatment, and maternal and fetal outcomes in women with prediabetes before or at the beginning of pregnancy. The aim of this study was to comprehensively characterize women with prediabetes compared to women with type 2 diabetes mellitus. STUDY DESIGN: This was a retrospective cohort data from a single medical center treating women with pregestational prediabetes mellitus (PDM). Women were compared to pregestational overt type 2 diabetes mellitus (T2DM). RESULTS: Data were collected from 120 women in the PDM group and 86 women in the T2DM group. Baseline characteristics were comparable, albeit women in the PDM group arrived at medical attention significantly later, 55% after 15 weeks gestation. Women with PDM needed significantly less treatment to achieve glycemic control and glycated hemoglobin remained lower throughout pregnancy. Maternal and fetal outcomes were similar between groups, although significantly higher rates of macrosomia and neonatal jaundice were observed in the T2DM group. CONCLUSIONS: The lack of clear guidelines causes a delay in the first prenatal visit of women with PDM. Comparable pregnancy outcomes may tip the balance toward acceptance of early treatment. Establishing clear guidelines will enable primary caregivers to refer prediabetic women sooner for lifestyle modifications and treatment if needed.

Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

PURPOSE/BACKGROUND: Since its US Food and Drug Administration approval in 1996, olanzapine has been one of the most commonly prescribed atypical antipsychotics, making a better understanding of its reproductive safety profile critical. The goal of the current analysis was to determine the risk of major malformations among infants exposed to olanzapine during pregnancy compared with a group of nonexposed infants. METHODS/PROCEDURES: The National Pregnancy Registry for Psychiatric Medications is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Labor and delivery and pediatric medical records were screened for evidence of major malformations followed by adjudication by a dysmorphologist blinded to medication exposure. Infants with first-trimester exposure to olanzapine were compared with controls without second-generation antipsychotic exposure. FINDINGS/RESULTS: As of April 18, 2022, 2619 women have enrolled in the study. At the time of data extraction, 49 olanzapine-exposed infants and 1156 infants in the comparison group were eligible for these analyses. There were no major malformations associated with olanzapine exposure in the first trimester. The absolute risk for major malformations in the exposure group was 0.00% (95% confidence interval, 0.00-7.25) for olanzapine compared with 1.64% (95% confidence interval, 0.99-2.55) in the control group. IMPLICATIONS/CONCLUSIONS: In this prospective cohort, no major malformations were associated with olanzapine exposure during the first trimester. Although these data are preliminary and cannot rule out more modest effects, they are nonetheless important, adding to the growing reproductive safety data for olanzapine.

Establishment of the MGH Postpartum Psychosis Project: MGHP3.

OBJECTIVE: Postpartum psychosis (PP) is a severe psychiatric disorder, with incomplete consensus on definition and diagnostic criteria. The Massachusetts General Hospital Postpartum Psychosis Project (MGHP3) was established to better ascertain the phenomenology of PP in a large cohort of diverse women spanning a wide geographical range (primarily in the US), including time of onset, symptom patterns, and associated comorbidities, psychiatric diagnoses pre- and post- the episode of PP, and also to identify genomic and clinical predictors of PP. This report describes the methods of MGHP3 and provides a status update. METHOD: Data are collected from women who experienced PP within 6 months of childbirth and who provided this information within ten years of the study interview. Subject data are gathered during a one-time structured clinical interview conducted by phone, which includes administration of the Mini International Neuropsychiatric Interview for Psychotic Disorders Studies (Version 7.0.2), the MGHP3© Questionnaire, and other information including lifetime mental health history and use of psychiatric medications both prior to the episode of PP and during the subsequent time period prior to study interview. Subjects also provide a saliva sample to be processed for genomic analyses; a neuroimaging assessment is also conducted for a subset of participants. RESULTS: As of July 1, 2022, 311 subjects from 44 states and 7 countries were enrolled in MGHP3. Recruitment sources include social media, online advertisements, physician referral, community outreach, and partnership with PP advocacy groups. CONCLUSIONS: The rigorous phenotyping, genetic sampling, and neuroimaging studies in this sample of women with histories of PP will contribute to better understanding of this serious illness. Findings from MGHP3 can catalyze ongoing discussions in the field regarding proper nosologic classification of PP as well as relevant treatment implications.

Risk of Poor Neonatal Adaptation Syndrome Among Infants Exposed to Second-Generation Atypical Antipsychotics Compared to Antidepressants: Results From the National Pregnancy Registry for Psychiatric Medications.

Objective: While poor neonatal adaptation syndrome (PNAS) has been particularly well described among infants exposed to antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), this is not the case for second-generation antipsychotics (SGAs). In 2011, the US Food and Drug Administration (FDA) issued a drug safety warning regarding fetal antipsychotic exposure and risk for PNAS and extrapyramidal symptoms (EPS). The primary objective of this study was to examine the risk for PNAS among infants exposed to SGAs compared to SSRI/SNRI-exposed infants, leveraging the prospective, longitudinal design of the National Pregnancy Registry for Psychiatric Medications (NPRPM).Methods: The NPRPM is a prospective pharmacovigilance program in which pregnant women, aged 18-45 years, are enrolled and followed prospectively. Medical records were systematically reviewed and data abstracted using a checklist of PNAS and EPS symptoms specifically outlined in the FDA drug safety warning. The two study groups included infants exposed to an SGA during pregnancy and infants exposed to an SSRI/SNRI during pregnancy. The primary outcome was the presence of at least one or more PNAS symptoms during the first month of life. Other neonatal outcomes following exposure to the medication of interest, including preterm birth, neonatal intensive care unit (NICU) admission, rates of EPS, and whether infants were discharged home with their mothers, are also reported.Results: Of the 2,145 women enrolled in this study as of December 16, 2020, a total of 373 women and their infants (n = 384) were eligible for inclusion (n = 193 SGA-exposed infants and 191 SSRI/SNRI-exposed infants). Among SGA-exposed infants, 32.6% (63/193) experienced at least 1 PNAS sign compared to 34.6% of infants (66/191) in the SSRI/SNRI-exposed group. The majority of infants in each group showed no symptoms of PNAS. No differences were observed between the two groups with respect to rates of preterm birth, NICU admission, prevalence of EPS, and timing of infants being discharged home with their mothers.Conclusions: PNAS symptomatology was comparable among infants exposed prenatally to an SGA or to an SSRI/SNRI. These preliminary findings provide an estimated risk of PNAS among infants exposed to SGAs of roughly 30%. Interestingly, these findings are also consistent with estimates in the literature of PNAS in SSRI/SNRI-exposed infants, suggesting a possible common pathway underlying this phenomenon.Trial Registration: ClinicalTrials.gov identifier: NCT01246765.

Reproductive Safety of Lurasidone and Quetiapine: Update from the National Pregnancy Registry for Psychiatric Medications.

Background: Second-generation antipsychotics (SGAs), also called atypical antipsychotics, are common therapies for women with a spectrum of psychiatric disorders. No systematically ascertained human reproductive safety data are available for lurasidone, and prospective data for quetiapine are limited, making decisions regarding use of these medications during pregnancy complicated. Materials and Methods: The National Pregnancy Registry for Psychiatric Medications is a prospective cohort study designed to collect reproductive safety data relative to SGAs. Pregnant women aged 18-45 years, with psychiatric illness and prenatal psychotropic medication exposure completed three phone interviews during pregnancy and the postpartum period. Cases of presumed malformations are abstracted from medical records for adjudication by a teratologist blinded to medication exposure. Results: Of 2,293 women enrolled at the time of analysis, 134 in the lurasidone group, 264 in the quetiapine group, and 886 controls completed the postpartum interview and were therefore eligible for inclusion. Dropped or lost-to-follow-up participants (13%) and those currently pregnant were excluded. Participants were predominantly White, college-educated, and married (lurasidone = 88.1%, 76.9%, 77.6%; quetiapine = 89.8%, 71.2%, 75.0%; controls = 92.7%, 86.7%, 89.1%). Absolute risks of major malformations were 2.19% (lurasidone), 1.85% (quetiapine), and 1.77% (controls). Odds ratios comparing lurasidone and quetiapine with controls were 1.24 (95% confidence interval [CI] = 0.36-4.32) and 1.04 (95% CI = 0.38-2.85), respectively. Conclusions: No specific patterns of malformations were observed in infants exposed to the medications of interest. Lurasidone and quetiapine did not appear to be major teratogens, but further information is needed to refine risk estimates. Food and Drug Administration guidance underscores the importance of pregnancy registries. Clinical trial number: NCT01246765.

Obesity Stratification Predicts Short-Term Complications After Parastomal Hernia Repair.

INTRODUCTION: While previous studies have documented adverse outcomes among obese patients undergoing ventral and inguinal hernia repairs, there is a lack of literature regarding the impact of obesity on parastomal hernia (PSH) repair. This retrospective study aims to determine the value of obesity stratification in predicting postoperative complications in patients undergoing PSH repair. MATERIALS AND METHODS: Outcomes of elective PSH repairs from 2010 to 2020 in the American College of Surgeons National Surgical Quality Improvement Program database were analyzed. Patient demographics, preoperative characteristics, and postoperative outcomes were compared using bivariate analysis and multivariable regression models. RESULTS: A total of 2972 patients were retrospectively analyzed. Multivariable regression found, compared to nonobese patients, patients of obesity class ≥ II were 1.37 times more likely to develop complications overall (P = 0.006) and 1.55 times more likely to develop wound complications (P < 0.001). This group also yielded a 1.60 times higher risk of developing superficial wound infection (P = 0.007) and a 1.63 times greater risk of developing postoperative sepsis (P = 0.044). Total length of stay was longer for patients of obesity class ≥ II but not for obesity class I when compared to patients with body mass index <30.0 kg/m2. CONCLUSIONS: Patients with a body mass index ≥35.0 kg/m2 are more susceptible to an increased rate of complications after PSH repairs. The findings of this study will allow surgeons to stratify obese patients who would benefit from preoperative weight loss interventions prior to PSH repair and discuss associated risks with patients to facilitate informed consent.

Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications.

BACKGROUND: Perinatal anxiety affects 20% of women, and untreated maternal mental illness can cause deleterious effects for women and their children. Benzodiazepines are commonly used to treat anxiety disorders. The reported risk of congenital malformations after in utero benzodiazepine exposure has been inconsistent. METHODS: The Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications prospectively enrolls pregnant women with psychiatric illness who take one or more psychiatric medications. Participants are interviewed twice during pregnancy and at 12 weeks postpartum. Women taking any benzodiazepine during the first trimester of pregnancy were compared with a group of women taking psychiatric medication(s) other than benzodiazepines during pregnancy. RESULTS: A total of 1053 women were eligible for this analysis; N = 151 women who had taken a benzodiazepine during the first trimester, and the comparison group was N = 902 women. There were 5 (3.21%) major malformations in the exposure group and 32 (3.46%) in the comparison group (odds ratio 0.92; 95% confidence interval 0.35-2.41). CONCLUSION: This ongoing pregnancy registry offers reassurance that benzodiazepines do not appear to have major teratogenic effects. The precision of relative risk estimate will improve as the number of participants increases. This and other pregnancy registries will better inform the reproductive safety of benzodiazepines.

Neurobehavioral follow-up of children exposed to selective serotonin reuptake inhibitors in utero.

BACKGROUND: Systematic data regarding long-term neurobehavioral effects of maternal antidepressant use during pregnancy are sparse. The aim of this study was to evaluate the impact of gestational exposure to antidepressants on later neurodevelopmental function. METHODS: This study describes a cohort of mother-child dyads (44 mothers, 54 children) in which maternal depressive symptoms and medication exposures were prospectively collected across pregnancy and the postpartum period. Children age 6 to 17 were assessed using validated instruments across domains of childhood behavior and executive memory and functioning. RESULTS: No associations were found between maternal use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and atypical neurodevelopment of children. Borderline clinical or clinical ranges of internalizing symptoms were associated with exposure to a higher maternal depressive symptom burden during pregnancy compared with those in the normal range. Compared with age- and sex-matched controls, the SSRI-exposed group showed superior performance on executive function tasks; findings did not demonstrate elevated risk for abnormal neurodevelopment in children age 6 to 17 exposed to SSRIs in utero. Deviations from the norm were instead associated with higher in utero exposure to maternal depression burden. CONCLUSIONS: This study highlights the need for rigorous studies of long-term outcomes after fetal antidepressant exposure.

Pregnancy outcomes after first-trimester exposure to buspirone: prospective longitudinal outcomes from the MGH National Pregnancy Registry for Psychiatric Medications.

Buspirone is commonly used to treat anxiety disorders among reproductive-aged women. To date, the reproductive safety of buspirone in humans has been particularly sparse. We sought to provide preliminary data from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications (NPRPM) on the risk of major malformations after first-trimester buspirone exposure. The NPRPM enrolls pregnant women with psychiatric disorders to prospectively assess for major congenital malformations after in utero exposure to psychotropics. Women are interviewed twice during pregnancy and once at 12 weeks postpartum. Data regarding women who took buspirone during the first trimester were extracted from the NPRPM database. Data were assessed as a rigorously ascertained case series to determine the incidence of major malformations among those exposed to buspirone. The primary outcome was obtained by maternal postpartum interview and medical record review. As of January 6, 2022, N = 97 women enrolled in the registry took buspirone during their first trimester. Of these women, 68 were evaluable and eligible for this analysis. Four women had twins, resulting in 72 infants. Among this sample, there were no malformations present. These preliminary data represent the only prospectively ascertained sample of pregnancy outcomes after first-trimester buspirone exposure. Albeit a small sample, no major malformations were observed in this cohort. The rigorous prospective ascertainment of outcomes is a strength of this study. Future analyses are planned that will include larger numbers of women with exposures to buspirone and comparison with control groups matched for demographic and diagnostic variables.