Project HOPE 1000: Health Outcomes Pregnancy Exposures
- Conditions
- Pregnant
- Registration Number
- NCT04417283
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of a data repository to provide a secure, centralized storage location for samples from pregnant women. Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke affiliated ObGyn clinics within Duke Health
🇺🇸Durham, North Carolina, United States