Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04417283 |
| Other study ID # |
Pro00100000 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2018 |
| Est. completion date |
July 1, 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Duke University |
| Contact |
Jennifer Gilner, MD |
| Phone |
919-684-6327 |
| Email |
jennifer.gilner[@]duke.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of this study is to collect biological samples from pregnant women and their
babies and to collect data on long-term health, school outcomes, and the use of state and
county services. The information learned from this study may help identify important factors
that may influence the health of mothers and babies, both short-and long-term.
Description:
Humans pass through more biological milestones during gestation and the first two years of
life (known as the "first 1000 days") than during any other period of development.
Consequently, both intrinsic biology/physiology and extrinsic factors such as environmental
exposures can have profound impacts on long-term health and disease outcomes. The purpose of
this project is to develop a cohort of mother-infant dyads that can provide a collection of
birth samples and be studied long-term - from pregnancy through early childhood - to help
identify early life factors that influence lifelong health and disease. The study will
include collection of specimens from pregnant women during each trimester of pregnancy, at
delivery, and within the first few months after giving birth, as well as collection of
specimens from the infants at birth and during their first two years of life. In addition to
specimens, health information will be collected from the participants' electronic health
records, and via questionnaires to assess health behaviors, social determinants, and
environmental exposures. Participants may also consent for yearly review of state
administrative data, including educational data, social services, and vital records. The
specimens and data collected in this study will allow for assessment of the impact of
different factors during pregnancy and early childhood on long-term health and well-being.
