Current 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 is 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 will also assess for the outcomes in relation to specific opioids and will assess 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 projects is to develop and validate Medicaid-specific algorithms to estimate gestational age for live birth and non-live birth pregnancies. We will also develop 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 is 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 is 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 will be 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 is 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 aims 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 is 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 is 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. 

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Completed projects

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.