Current projects

2018-2023

​In Utero Exposure to Psychotropic Medications and the Risk of Neurodevelopmental Disorders
PI: Krista Huybrechts
NIMH: National Institute of Mental Health 1R01MH116194-01

​Animal models suggest potential cognitive teratogenicity following in utero exposure to psychotropic medications, but there is limited to no information on the risk of neurodevelopmental disorders (i.e., autism spectrum disorder, attention deficit/hyperactivity disorder, and developmental delays) in humans. Using two national cohorts of over 4 million publicly and privately insured pregnancies and state of the art epidemiologic methods, we will evaluate the risk of neurodevelopmental outcomes following in utero exposure to specific psychotropic medications (i.e., mood stabilizers and other anticonvulsant drugs, antidepressants, antipsychotics, psychostimulants).
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2019-2024

Comparative Safety of Non-Insulin Agents in Pregnant Women with Pregestational Diabetes
PI: Sonia Hernandez-Diaz
NICHD: National Institute of Child Health and Human Development R01HD097778

The best way to reduce the known maternal and fetal risks associated with pre-gestational diabetes is to maintain excellent glycemic control before and during pregnancy. The lack of data on the safety of oral antidiabetic medications in the prenatal period has been a barrier to their use in pregnant women even when they may be beneficial, particularly for patients that don't need or don't tolerate insulin injections. The objective of the project is therefore to evaluate the comparative risks and benefits of non-insulin therapies in a large cohort of pregnant women and their infants.​

​2020-2024

The Comparative Effectiveness and Safety of Pharmacotherapies for the Treatment of Opioid Use Disorder in Pregnancy
PIs: Brian Bateman & Krista Huybrechts
NIH: National Institute on Drug Abuse R01-DA049822-01

The prevalence of opioid use disorders (OUD) during pregnancy has increased markedly over the past 15 years. It is recommended that pregnant women with OUD be treated with opioid agonist therapy (OAT) – i.e., methadone or buprenorphine – to prevent opioid withdrawal symptoms and to reduce the risk of illicit substance use during pregnancy; however, little is known about the comparative safety and effectiveness of methadone and buprenorphine, as well as of buprenorphine monotherapy compared to buprenorphine combined with naloxone, with respect to many important pregnancy outcomes. The goal of the proposed study is to provide robust information on the effects of available pharmacotherapies to treat OUD during pregnancy.​

2021-2026

Active Surveillance of the Safety of Antipsychotic Medications in Pregnancy
PIs: Shirley Wang & Krista Huybrechts
NICHD: National Institute of Child Health and Human Development R01HD104646

Mental health conditions are common among pregnant and postpartum women, and there is an urgent need to develop timely evidence regarding the safety of antipsychotic medications when used during pregnancy. We propose developing and implementing TreeScan, a novel signal detection method, for simultaneous evaluation of a broad range of potential maternal, fetal and neonatal adverse outcomes as part of a near real-time active safety surveillance system for antipsychotic medication use in pregnancy. Such an approach will not only avoid unnecessary exposure for mother and fetus to potentially harmful medications but, equally important, will provide re-assurance when no large harmful effects are detected so that women are not unnecessarily deprived of important medications for the treatment of psychiatric disorders.​

2022-2027

TreeScan to Evaluate the Safety of New Drugs in Pediatric Populations 
PIs: Shirley Wang & Krista Huybrechts
NICHD: National Institute of Child Health and Human Development R01HD110092

Children are not small adults; yet clinicians treating pediatric patients rely heavily on information collected in randomized and non-randomized studies of adult populations. To address this evidence gap – which puts pediatric patients at increased risk – we propose to develop and test the performance of tree-based scan statistic (TreeScan) approaches for the systematic and simultaneous evaluation of multiple potential adverse outcomes in pediatric populations, and to implement these methods for prospective sequential surveillance of new pediatric medications. This project will provide a critically needed tool that could lead to early detection of unsuspected adverse effects of drugs in pediatric populations if they exist and provide reassurance if no such safety concerns are detected.​​

2022-2027

Safety of Benzodiazepines and Non-Benzodiazepine Sedative Hypnotics in Pregnancy
PIs: Krista Huybrechts & Brian Bateman
NIH: National Institute of Child Health and Human Development R01HD107772

Anxiety disorders and insomnia are common during pregnancy and treatment with benzodiazepines and non- benzodiazepine sedative hypnotics is often indicated, yet rigorous and comprehensive safety data to inform the risk-benefit trade-off are sparse, evidence is conflicting, and numerous safety concerns have been raised. To address this critical information gap we propose to generate high-quality evidence on the safety of benzodiazepines and non-benzodiazepine sedative hypnotics during pregnancy considering a broad range of clinically relevant adverse pregnancy outcomes. Evidence generated will not only prevent unnecessary exposure for mother and fetus at time points during pregnancy when the medication may be harmful but will also provide guidance and reassurance as to when the medication can be used safely.​

Completed projects

2017-2021

The Impact of Prescription Opioid Use on Pregnancy Outcomes
PI: Brian Bateman
NIH: National Institute on Drug Abuse R01-DA044293

The study objective was to evaluate the association between prescription opioid exposure during the etiologically relevant pregnancy window and a variety of important adverse pregnancy outcomes previously hypothesized to be associated with such exposure.  We also assessed for the outcomes in relation to specific opioids and assessed the impact of duration of exposure and dose.

2017-2019

​Developing the capability of using national Medicaid data for FDA post-marketing surveillance to assess medication safety during pregnancy
PI: Krista Huybrechts
Food and Drug Administration (FDA) RFTOP-1180790

The objective of this project was to develop and validate Medicaid-specific algorithms to estimate gestational age for live birth and non-live birth pregnancies. We also developed analytic tools to assess the impact on relative risk estimates of exposure misclassification, outcome misclassification, selection bias, and residual confounding.

2017-2019

Ondansetron and risk of congenital malformations
PI: Krista Huybrechts
NIH: National Institute of Child Health and Human Development 1R03HD0916990-01

The study objective was to evaluate the risk of congenital heart defects and cleft palate associated with ondansetron use during the first trimester of pregnancy in a national cohort of 1.6 million pregnancies covered by Medicaid.

2017-2019

Pregnancy Registries Nested in International Pooled Health Care Databases 
PI: Sonia Hernandez-Diaz
NIH: National Institute of Child Health and Human Development R21-HD092879

The study objective was to develop an international collaboration to study the safety of drugs in pregnancy. By pooling health care information from large population-based databases in the Nordic Countries and the United States, we were able to identify global nested exposed pregnancy cohorts to study in utero exposure to individual drugs in relation to rare outcomes such as specific birth defects.

2016-2018

​Observational Studies to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine
PI: Krista Huybrechts
Eli Lilly and Company

The study objective was to evaluate maternal and fetal/infant outcomes associated with exposure to duloxetine; part of fulfillment of a Food and Drug Administration requirement for post-marketing surveillance.

2013-2018

Comparative Safety and Effectiveness of Antihypertensive Medications in Pregnancy 
PI: Brian Bateman
NIH: National Institute of Child Health and Human Development 5K08HD075831-05

About 4% of all pregnant women will take an antihypertensive medication during pregnancy. Much is unknown about the comparative safety and effectiveness of different antihypertensives in pregnancy. The study aimed to define the class of antihypertensive agent that is safest for the fetus and the one most likely to assure a good pregnancy outcome.

2016-2017

​Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Albiglutide during Pregnancy
PI: Sonia Hernandez-Diaz
GlaxoSmithKline

The study objective was to determine whether exposure to albiglutide during pregnancy is associated with an increased risk of pre-specified adverse maternal and fetal outcomes.

2016-2017

Observational Cohort Study to Assess Maternal Asthma during Pregnancy and its Association with Fetal Outcomes
PI: Sonia Hernandez-Diaz
GlaxoSmithKline

The study goal was to describe the frequency of the most common fetal and neonatal outcomes within women with severe and non-severe asthma, as well as in a reference group of women without asthma. 

2004-2017

Comparative Safety of commonly prescribed Psychotropic Drugs in Pregnant Women 
PI: Sonia Hernandez-Diaz
​NIH: National Institute of Mental Health R01-MH100216

The study objective was to provide direct evidence on the safety of alternative strategies used to manage mood disorders, psychosis, and attention deficit hyperactivity disorders (ADHD) in a population of pregnant women, which includes vulnerable indigent young women. In particular, we compared the risk of adverse pregnancy and neonatal outcomes following the use of specific anticonvulsants/mood stabilizers, antipsychotics, and stimulants; and assessed the effect of continuing versus discontinuing these drugs during pregnancy.

2009-2014

Comparative Effectiveness and Safety of Depression Treatments During Pregnancy 
PI: Sonia Hernandez-Diaz
AHRQ R01-HS018533

The primary objective was to generate evidence on the outcomes of treatments to manage depression in low-income pregnant women and their children.