Clinical trial NCT04417283: Project HOPE 1000: Health Outcomes Pregnancy Exposures
Official title: Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnant
Keywords: Pregnancy
Gestation
Placenta
Exposure
Environment
Social Drivers of Health
Infancy
Biological specimens
Electronic health records
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mother and/or infant participants will provide a series of biological specimens, including blood, urine, and microbiome samples. Additionally, each participant will wear a silicone wrist band each trimester to capture environmental exposures and will fill out study surveys related to diet, environmental exposures, and social factors.

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.

Eligibility criteria: Inclusion criteria:

* The subject has provided a signed Informed consent prior to any study procedures.
* Maternal age at consent of ≥ 18 years old
* Ability to understand English or Spanish
* Willingness to comply with and be available for all protocol procedures
* Singleton gestation \< 24 weeks 0 days
* Receiving prenatal care at a Duke-affiliated Obstetrics clinic with the intent of delivering at Duke University Health System-affiliated hospital (including Duke University Hospital and Duke Regional Hospital)
* Plans to have their infant seen at a Duke-affiliated Pediatrics practice after birth
* Plans to remain in the area for two years after delivery

Exclusion criteria:

* Non-viable pregnancy
* Having any condition that, in the opinion of the site investigators, would place the subject at unacceptable risk of injury or confound data interpretation

Primary outcomes:
measure: Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke affiliated ObGyn clinics within Duke Health
state: North Carolina
Study officials:
affiliation: Duke University
name: Jennifer Gilner, MD
role: PRINCIPAL_INVESTIGATOR
References: