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Emerging Infections and Treatment in Pregnancy EI-TIP

Funded by CDC, EI-TIP addresses one of CDC's research priorities within its program Applied Research to address Public Health Priorities: to address critical knowledge gaps related to emerging and re-emerging infectious disease during pregnancy and the risk, benefits and acceptance of prevention and treatment strategies.

Specific aims

Emerging infections have significant effects on public health, especially in vulnerable populations like pregnant women. With increasing prevalence of hepatitis C and risk for perinatal transmission, recent recommendations include universal HCV screening during pregnancy. To what extent these recommendations have been implemented, and whether diagnosis results in expeditious maternal treatment and follow-up among infants is unclear. 

Also, pregnant women are vulnerable in the event of an intentional release of infectious agents. Doxycycline is used for a variety of common pathogens, and is recommended for postexposure prophylaxis for bacillus anthracis and yersinia pestis. Although doxycycline has been on the market for decades, safety data on fetal risk and long-term effects in infants are incomplete.

The EI-TIP study will employ comprehensive databases of linked mother and baby cohorts enhanced with additional multiple data that capture patient, provider and community-level characteristics to study two focus areas, each with multiple aims: 

  1. Impact of recommendations for universal HCV screening during pregnancy, and 
  2. Safety of prenatal exposure to doxycycline and fetal and infant outcomes

Special features

EI-TIP takes advantage of extensive research infrastructure that can be used to examine the intersection of emerging infections and therapeutics to guide efforts to mitigate adverse maternal, fetal, and infant outcomes. While building on long-established pharmacoepidemiological principles, we introduce an innovative analytical data mining component in our analysis of doxycycline safety to optimize our ability to detect signals that may warrant formal follow-up. We also optimize the utility of our claims-based mother-baby cohorts, offering the opportunity for longitudinal follow-up of one of the largest cohorts of pregnancies, via targeted linkages to other data to enhance the validity and breadth of measures.

EI-TIP data environment

Study team

EI-TIP is a collaboration of researchers at the University of Florida, Johns Hopkins University, Harvard and the Centers for Disease Control and Prevention (CDC). Funded by CDC, EI-TIP addresses one of CDC’s research priorities, which aims to address critical knowledge gaps related to emerging and re-emerging infectious disease during pregnancy and the risk, benefits and acceptance of prevention and treatment strategies. Our team combines experts in epidemiology, Pharmacoepidemiology, genetics, child and maternal health, data mining and signal detection, and infectious disease.

Principal investigator

Almut G Winterstein, RPh, PhD, FISPE, ASEMFL

Distinguished Professor in Pharmaceutical Outcomes & Policy, Director Center for Drug Evaluation & Safety, University of Florida

Almut Winterstein

Co-Principal investigator

Sonja A Rasmussen, MD, MS

Professor of Genetic Medicine, Johns Hopkins Medicine

Sonja Rasmussen

Co-investigator

Judith Maro, MS, PhD

Assistant Professor on Population Medicine, Harvard Medical School

Jud Maro

co-investigator

Thuy Thai, BSPharm, MS, PhD

Assistant Scientist, Pharmaceutical Outcomes & Policy, University of Florida

Thuy Thai

Post-doctoral fellow

Jerry Idigo, BSPharm, MPH, PhD

Post-doctoral Fellow, Pharmaceutical Outcomes & Policy, University of Florida

Jerry Idigo

Data analyst

Carl Henriksen, MS

Data Management Analyst, Pharmaceutical Outcomes & Policy, University of Florida

Carl Henriksen

reserach assistant

Nicole Smolinski, PharmD

Graduate student, Pharmaceutical Outcomes & Policy, University of Florida

Nicole Smolinski

research assistant

Celeste Ewig, PharmD

Graduate student, Pharmaceutical Outcomes & Policy, University of Florida

Celeste Ewig

research assistant

Matthew Muschett, PharmD

Graduate student, Pharmaceutical Outcomes & Policy, University of Florida

Matt Muschett

research assistant

Priyanka Kulkarni, BSPharm, MS

Graduate student, Pharmaceutical Outcomes & Policy, University of Florida

Priyanka Kulkarni

research assistant

Hung-Kai (Henry) Chen

Graduate student, Pharmaceutical Outcomes & Policy, University of Florida

Henry Chen

visiting scholar

Junko NAGAI, PhD

Visiting scholar, Pharmaceutical Outcomes & Policy, University of Florida

Junko Nagai