PregnantNCT04417283
Project HOPE 1000: Health Outcomes Pregnancy Exposures
An observational study of Pregnant, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 1 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke affiliated ObGyn clinics within Duke Health
Durham, North Carolina, 27710
About this study
Official title: Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures
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.
Read the 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.
- Conditions
- Pregnant
- Keywords
- Pregnancy, Gestation, Placenta, Exposure, Environment, Social Drivers of Health, Infancy, Biological specimens, Electronic health records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Nov 2018
- Primary completion22 Nov 2024
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Gilner, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417283
- Sponsor's protocol ID
- Pro00100000
- Status last verified
- Aug 2026
- First submitted
- 2 Jun 2020
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures
- ClinicalTrials.gov ID
- NCT04417283
- Acronym / sponsor ID
- Pro00100000
- Conditions
- Pregnant
- Keywords
- Pregnancy, Gestation, Placenta, Exposure, Environment, Social Drivers of Health, Infancy, Biological specimens
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Gilner, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.