Assessing the Impact of Exposure Misclassification in Case-Control Studies of Self-Reported Medication Use.

Background: Empirically evaluating the potential impact of recall bias on observed associations of prenatal medication exposure is crucial.

Objective: We sought to assess the effects of exposure misclassification on previous studies of the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in early pregnancy and increased risk of amniotic band syndrome (ABS).

Methods: Using data from the National Birth Defects Prevention Study (NBDPS) on births from 1997 to 2011, we included 189 mothers of infants with ABS and 11,829 mothers of infants without congenital anomalies.

An exploration of potential risk factors for gastroschisis using decision tree learning.

Purpose: Despite a wealth of research, the etiology of the abdominal wall defect gastroschisis remains largely unknown. The strongest known risk factor is young maternal age. Our objective was to conduct a hypothesis-generating analysis regarding gastroschisis etiology using random forests.

Neurobehavioral outcomes of infants exposed to buprenorphine-naloxone compared with naltrexone during pregnancy.

Background: Naltrexone is a medication used to treat both opioid and alcohol use disorder with limited experience in pregnant individuals, particularly in comparison to more commonly utilized treatments such as buprenorphine-naloxone. The long-term outcomes of infants exposed to naltrexone has not been previously examined.

Aims: To compare the neurobehavioral outcomes of naltrexone versus buprenorphine-naloxone exposed infants.

Real-world data are not always big data: the case for primary data collection on medication use in pregnancy in the context of birth defects research.

Many examples of the use of real-world data in the area of pharmacoepidemiology include "big data," such as insurance claims, medical records, or hospital discharge databases. However, "big" is not always better, particularly when studying outcomes with narrow windows of etiologic relevance. Birth defects are such an outcome, for which specificity of exposure timing is critical.

The timing, duration, and severity of nausea and vomiting of pregnancy and adverse birth outcomes among controls without birth defects in the National Birth Defects Prevention Study.

Background: Nausea and vomiting of pregnancy (NVP) occurs in approximately 70% of pregnant people, with varying severity and duration. Treatments include pharmacologic and herbal/natural medications. The associations between NVP and birth outcomes, including preterm birth, small for gestational age (SGA), and low birth weight are inconclusive.

Caregiver strategies supporting community participation among children and youth with or at risk for disabilities: a mixed-methods study.

Introduction: The purpose of this mixed-methods study is to examine the role of caregiver strategies to support community participation among children and youth with disabilities and those at risk, from the caregiver perspective. For the quantitative phase, we tested the hypothesized positive effect of participation-focused caregiver strategies on the relationship(s) between participation-related constructs and community participation attendance and involvement. For the qualitative phase, we solicited caregiver perspectives to explain the quantitative findings.

Case Series of Individuals Treated With Naltrexone During Pregnancy for Opioid and/or Alcohol Use Disorder.

Objective: There is a lack of knowledge about the relative safety and efficacy of naltrexone for the treatment of pregnant individuals with opioid and/or alcohol use disorder, including the range of outcomes, in both the pregnant individual and the infant, over the course of peripartum period. Our objective was to describe these outcomes in a cohort of pregnant individuals on naltrexone.

Methods: In this prospective case series, 7 pregnant individuals with opioid use disorder (OUD) or alcohol use disorder (AUD) treated with naltrexone were followed from pregnancy through 12 months after delivery.

Antifungal medication use during early pregnancy and the risk of congenital heart defects in the National Birth Defects Prevention Study, 1997-2011.

Background: Fungal infections are common among pregnant people. Recent studies suggest positive associations between oral antifungals used to treat fungal infections and congenital heart defects (CHDs).

Methods: We estimated associations between first trimester antifungal use and 20 major, specific CHDs using data from the National Birth Defects Prevention Study (NBDPS), a multi-site, case-control study that included pregnancies with estimated delivery dates from October 1997 through December 2011.

Public health priorities for gastroschisis: Summary of a meeting sponsored by the Centers for Disease Control and Prevention and the March of Dimes.

Background: Gastroschisis has increased worldwide over several decades; however, there are significant gaps in understanding risk factors for development of the defect, particularly those that might be modifiable. Despite advances in survival, little is known about longer-term outcomes for affected individuals.

Methods: On April 27- and 28, 2023, the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC) and March of Dimes sponsored a meeting entitled "Public Health Priorities for Gastroschisis".

Hair Cortisol Concentrations in Opioid-Exposed versus Nonexposed Mother-Infant Dyads.

Objective: To pilot measurement of hair cortisol concentration (HCC) in pregnant women with opioid use disorder and their infants over time and study the potential utility of hair cortisol as a biomarker of chronic stress in this population.

Study Design: In this pilot prospective cohort study of mother-infant dyads with and without prenatal opioid exposure, we obtained mother-infant HCCs at delivery and again within 1 to 3 months' postpartum. HCCs were compared between the opioid and control groups and between the two time points.

Antifungal medication use during pregnancy and the risk of selected major birth defects in the National Birth Defects Prevention Study, 1997-2011.

Purpose: Recent studies suggest increased birth defect risk associated with maternal use of specific oral antifungals. We estimated associations between first-trimester antifungal use and selected non-cardiac birth defects using National Birth Defects Prevention Study (NBDPS) data.

Methods: Participants with a pregnancy affected by a study-eligible birth defect ("cases") were ascertained from 10 birth defect surveillance programs; participants who delivered livebirths without a major birth defect ("controls") were randomly selected from birth records or hospital discharge lists.

Natural Language Processing to Classify Caregiver Strategies Supporting Participation Among Children and Youth with Craniofacial Microsomia and Other Childhood-Onset Disabilities.

Unlabelled: Customizing participation-focused pediatric rehabilitation interventions is an important but also complex and potentially resource intensive process, which may benefit from automated and simplified steps. This research aimed at applying natural language processing to develop and identify a best performing predictive model that classifies caregiver strategies into participation-related constructs, while filtering out non-strategies. We created a dataset including 1,576 caregiver strategies obtained from 236 families of children and youth (11-17 years) with craniofacial microsomia or other childhood-onset disabilities.

Investigating the association between vitamin D dietary intake during pregnancy and incidence of clubfoot in neonates.

Aims: Talipes equinovarus (clubfoot) is a congenital lower foot deformity that results from a neuromuscular deficiency, but the precise etiology remains elusive. Vitamin D is important for fetal neuromuscular development. In this study, we investigated the association between dietary vitamin D intake during pregnancy and incidence of clubfoot in neonates, since such a question has thus far been overlooked.

Is gastroschisis associated with county-level socio-environmental quality during pregnancy?

Background: Gastroschisis prevalence more than doubled between 1995 and 2012. While there are individual-level risk factors (e.g.

Rare variants in increase risk for isolated hypoplastic left heart syndrome.

Hypoplastic left heart syndrome (HLHS) is a severe congenital heart defect (CHD) characterized by hypoplasia of the left ventricle and aorta along with stenosis or atresia of the aortic and mitral valves. HLHS represents only ∼4%-8% of all CHDs but accounts for ∼25% of deaths. HLHS is an isolated defect (i.

Periconceptional intakes of methyl donors and other micronutrients involved in one-carbon metabolism may further reduce the risk of neural tube defects in offspring: a United States population-based case-control study of women meeting the folic acid recommendations.

Background: Neural tube defects (NTDs) still occur among some women who consume 400 μg of folic acid for prevention. It has been hypothesized that intakes of methyl donors and other micronutrients involved in one-carbon metabolism may further protect against NTDs.

Objectives: To investigate whether intakes of vitamin B6, vitamin B12, choline, betaine, methionine, thiamine, riboflavin, and zinc, individually or in combination, were associated with NTD risk reduction in offspring of women meeting the folic acid recommendations.

Are individual-level risk factors for gastroschisis modified by neighborhood-level socioeconomic factors?

Background: Two strong risk factors for gastroschisis are young maternal age (<20 years) and low/normal pre-pregnancy body mass index (BMI), yet the reasons remain unknown. We explored whether neighborhood-level socioeconomic position (nSEP) during pregnancy modified these associations.

Methods: We analyzed data from 1269 gastroschisis cases and 10,217 controls in the National Birth Defects Prevention Study (1997-2011).

Kinetics of SARS-CoV-2 Serum Antibodies Through the Alpha, Delta, and Omicron Surges Among Vaccinated Health Care Workers at a Boston Hospital.

Background: Longitudinal serology studies can assist in analyzing the kinetics of antibodies to SARS-CoV-2, helping to inform public health decision making. Our study aims to characterize circulating antibody trends over 18 months in vaccinated participants with and without evidence of COVID-19 infection.

Methods: A cohort of health care workers employed at Boston Medical Center was followed to collect serum samples and survey data over 6 time points from July 2020 through December 2021 (N = 527).

Patterns of Prescription Medication Use during the First Trimester of Pregnancy in the United States, 1997-2018.

The objective of this analysis was to describe patterns of prescription medication use during pregnancy, including secular trends, with consideration of indication, and distributions of use within demographic subgroups. We conducted a descriptive secondary analysis using data from 9,755 women whose infants served as controls in two large United States case-control studies from 1997-2011 and 2014-2018. After excluding vitamin, herbal, mineral, vaccine, i.

A comparison of postpartum opioid consumption and opioid discharge prescriptions among opioid-naïve patients and those with opioid use disorder.

Background: Management of patients with opioid use disorder during the acute postpartum period remains clinically challenging as obstetricians aim to mitigate postdelivery pain while optimizing recovery support.

Objective: This study aimed to evaluate postpartum opioid consumption and opioids prescribed at discharge among patients with opioid use disorder treated with methadone, buprenorphine, and no medication for opioid use disorder, as compared with opioid-naïve counterparts.

Study Design: We conducted a retrospective cohort study of pregnant patients who underwent delivery at >20 weeks' gestation at a tertiary academic hospital between May 2014 and April 2020.