Project HOPE 1000: Health Outcomes Pregnancy Exposures

NCT04417283 | Active Not Recruiting

• 1 other identifier: Pro00100000
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant

Keywords

Pregnancy; Gestation; Placenta; Exposure; Environment; Social Drivers of Health; Infancy; Biological specimens; Electronic health records

Outcome Measures

Primary Outcomes (1)

• Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.

  Up to 2 years

Study Arms (1)

Mother-infant dyads

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant participants can enroll in the first or second trimester of pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke affiliated ObGyn clinics within Duke Health

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected.

Study Officials

• Jennifer Gilner, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: November 21, 2018
• Primary Completion: November 22, 2024
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)