Long-Term Effects of Pentaerithrityl Tetranitrate (PETN) Treatment During Pregnancy: Follow-Up of Children from PETN Studies

What this Trial Is About

Pregnancies with impaired uterine blood flow identified during routine second-trimester exams are at high risk for fetal growth restriction (FGR), which affects about 10% of pregnancies. FGR can lead to lifelong physical and mental health challenges for children, including risks for type 2 diabetes, high blood pressure, metabolic imbalances, and cognitive and neurodevelopmental impairments. This study follows children born to mothers who participated in previous PETN treatment trials to evaluate long-term effects on their development. The study compares children whose mothers received either PETN or a placebo during their pregnancy in earlier trials. It involves two parts: first, participants complete questionnaires about the children's behavior and development; second, an on-site visit assesses the physical and mental health of the children. Various standardized tests and examinations are used, including behavioral checklists, intellectual assessments, physical measurements, metabolic tests, neurocognitive evaluations, and cardiovascular assessments. Participants aged 6 to 18 years, born to mothers from the PETN studies, are involved. Data collection includes questionnaires completed by parents or children and detailed physical and metabolic examinations conducted on-site. Researchers measure behavior, cognitive function, motor skills, physical growth, neurocognitive status, and cardiovascular health. The study monitors these outcomes over up to two years after enrollment to better understand the long-term impacts of PETN treatment during pregnancy.

Long-term Follow-up of Children Born in the PETN Studies