Project HOPE 1000: Health Outcomes Pregnancy Exposures
United States1,000 participantsStarted 2018-11-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.