Project HOPE 1000: Health Outcomes Pregnancy Exposures

August 7, 2025 updated by: Duke University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke affiliated ObGyn clinics within Duke Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Gilner, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00100000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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