Collecting health data and samples from pregnant women and their babies
Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures
Duke University · NCT04417283
This study is trying to collect health information and samples from pregnant women and their babies to see how different factors during pregnancy affect their long-term health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04417283 on ClinicalTrials.gov |
What this trial studies
This project aims to gather biological samples and health data from pregnant women and their infants to study the long-term health outcomes associated with various factors during pregnancy and early childhood. The study will track mother-infant pairs from pregnancy through the first two years of life, collecting specimens at multiple stages and health information through electronic records and questionnaires. By analyzing these data, researchers hope to identify key influences on health and well-being that could impact both mothers and their children over time.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older who are receiving prenatal care at a Duke-affiliated clinic and plan to deliver at a Duke University Health System hospital.
Not a fit: Patients with non-viable pregnancies or those with conditions that may pose unacceptable risks or confound data interpretation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into factors that influence maternal and infant health, potentially leading to improved health outcomes.
How similar studies have performed: Other studies focusing on maternal and infant health outcomes have shown success in identifying critical factors affecting long-term health, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina
- Duke affiliated ObGyn clinics within Duke Health — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Gilner, MD — Duke University
- Study coordinator: Jennifer Gilner, MD
- Email: jennifer.gilner@duke.edu
- Phone: 919-684-6327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnant, Pregnancy, Gestation, Placenta, Exposure, Environment, Social Drivers of Health, Infancy