Clinical trials and pregnancy

Waitt, Catriona; Astill, Denise; Zavala, Eleonor; Karron, Ruth A.; Faden, Ruth R.; Stratton, Pamela; Temkin, Sarah M.; Clayton, Janine Austin

doi:10.1038/s43856-022-00198-1

Cited by 6 publications

(2 citation statements)

References 15 publications

(18 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It is also possible that fewer women presented for screening due to other responsibilities such as work, childcare and household management preventing trial participation. The need to include pregnant and breastfeeding women in clinical trials has previously been highlighted, 17 , 18 and although clearly there should be some stratification regarding inclusion of this group, broad exclusion of all women of reproductive age leaves clinicians and women with little or no high-quality data on which to base intervention decisions.…”

Section: Discussionmentioning

confidence: 99%

Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya

Downs,

Campbell,

Abouyannis

et al. 2023

Journal of Virus Eradication

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya

Downs,

Campbell,

Abouyannis

et al. 2023

Journal of Virus Eradication

View full text Add to dashboard Cite

“…For example, clinical trials rarely include pregnant women, leaving knowledge gaps as to the potential toxicity to the fetus and pharmacokinetic differences between non-pregnant and pregnant women. 2 Additionally, there remains a lack of sizeable epidemiological cohort studies following children who were exposed to medications in utero. 3 Therefore, pregnant women and their physicians are often faced with the difficult decision of whether to continue the medication throughout pregnancy based on limited data.…”

Section: Introductionmentioning

confidence: 99%

PregPred: an In-Silico Alternative to Animal Testing for Predicting Developmental Toxicity Potential

Tieghi,

Rath,

Moreira-Filho

et al. 2024

Preprint

View full text Add to dashboard Cite

Background: Understanding potential prenatal and development toxicity hazard associated with the use of pharmaceutical and cosmetic products is an important component of women health. This hazard can be estimated from chemical structure of respective agents using Quantitative Structure-Activity Relationship (QSAR) models; however, the development of reliable models is challenging due to the complex nature of this endpoint. Methods: Aggregating and curating data from the Food and Drug Administration (FDA), Teratogen Information System (TERIS) database, and select independent studies, we have created, to the best of our knowledge, the largest publicly available dataset comprising compounds annotated as developmental toxicants or not toxicants. Results: We built several binary classification QSAR models exhibiting a correct classification rate of 62-72%, a sensitivity of 66-75%, a specificity of 59-82%, and high coverage of 70-90% assessed using five-fold external validation protocol. We developed a publicly accessible web portal PregPred for developmental toxicity prediction of both overall toxicity and trimester-specific toxicity predictions. Conclusions: Due to high accuracy and coverage as well as public accessibility of the respective web portal, our models can be employed as a computational tool to support regulatory assessment of pharmaceutical and cosmetic products in alignment with the 3Rs (refining, reducing, and replacing) of animal testing. This in silico model holds the potential to substantially influence the field of developmental toxicology, steering regulatory practices toward safer drug development for pregnant women. The first-of-its-kind curated dataset of developmental toxicants and all developed models implemented as a user-friendly web tool, PregPred, are freely available at https://pregpred.mml.unc.edu/).

show abstract

Perceptions of Magnetic Resonance Imaging During Pregnancy: A Newfoundland and Labrador Perspective

Barrett,

Stapleton,

Ringer

et al. 2024

Journal of Obstetrics and Gynaecology Canada

View full text Add to dashboard Cite

Clinical trials and pregnancy

Cited by 6 publications

References 15 publications

Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya

Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya

PregPred: an In-Silico Alternative to Animal Testing for Predicting Developmental Toxicity Potential

Perceptions of Magnetic Resonance Imaging During Pregnancy: A Newfoundland and Labrador Perspective

Contact Info

Product

Resources

About