Pregnant or Breastfeeding Women

Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk

Posted on by Kayla Korzekwinski

Clinical Pharmacology & Therapeutics • May 2022

Access article on PubMed.

Job KM, Dallmann A, Parry S, Saade G, Haas D, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K

Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lactation. This study developed a generic physiologically-based pharmacokinetic lactation model for small molecule drugs and applied this model to predict ondansetron transfer into breast milk and characterize infant exposure.

Pharmacokinetics of Hydroxychloroquine in Pregnancies with Rheumatic Diseases

Posted on by Kayla Korzekwinski

Clinical Pharmacokinetics • April 2019

Access article on PubMed.

Balevic SJ, Green TP, Clowse MEB, Eudy AM, Schanberg LE, Cohen-Wolkowiez M

 Hydroxychloroquine is an oral drug prescribed to pregnant women with rheumatic disease to reduce disease activity and prevent flares. Physiologic changes during pregnancy may substantially alter drug pharmacokinetics. However, the effect of pregnancy on hydroxychloroquine disposition and the potential need for dose adjustment remains virtually unknown. This study developed a one-compartment population-pharmacokinetic model for hydroxychloroquine in pregnant women with rheumatic disease.

Predictors of Prolonged Breast Milk Provision to Very Low Birth Weight Infants

Posted on by Kayla Korzekwinski

The Journal of Pediatrics • November 2018

Access article on PubMed.

Romaine A, Clark RH, Davis B, Hendershot K, Kite V, Laughon M, Updike I, Miranda ML, Meier PP, Patel AL, Smith PB, Cotton CM, Benjamin DK Jr, Greenberg RG

This study identified factors associated with prolonged maternal breast milk (BM) provision in very low birth weight (VLBW) infants. Results suggest that maternal-infant demographic and clinical factors and household neighborhood socioeconomic characteristics were associated with provision of maternal BM at 30 postnatal days to VLBW infants. Identification of these factors allows providers to anticipate mothers’ needs and develop tailored interventions designed to improve rates of prolonged maternal BM provision and infant outcomes.

Risk factors for group B streptococcal disease in neonates of mothers with negative antenatal testing

Posted on by Kayla Korzekwinski

Journal of Perinatology • February 2017

Access article on PubMed.

Parente V, Clark RH, Ku L, Fennell C, Johnson M, Morris E, Romaine A, Benjamin DK, Smith PB, Greenberg R

The aim of this study was to identify risk factors for early-onset group B Streptococcus (EOGBS) disease in neonates of mothers with negative antenatal screening. Maternal age <18 years and black race were the strongest predictors of EOGBS. Further research investigating contributors to the discordance between screening results and neonatal outcomes in these populations is needed.

Pharmacologic studies in vulnerable populations – using the pediatric experience

Posted on by Kayla Korzekwinski

Seminars in Perinatology • November 2016

Access article on PubMed.

Zimmerman K, Gonzalez D, Swamy GK, Cohen-Wolkowiez M
Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. Given the similar barriers to drug research and development in pediatric and pregnant populations, the route toward success in children may serve as a model for the advancement of drug development and appropriate drug administration in pregnant women.