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Can Early-Life exposures shape lifelong health? a 1000-Family study aims to find out

NCT ID NCT04417283

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study follows 1,000 pregnant women and their babies to understand how pregnancy and early-life exposures affect long-term health, school performance, and use of state services. Researchers will collect biological samples and health data from mothers and infants. The goal is to identify factors that may influence the health of mothers and babies, both in the short and long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This study could help identify factors that influence the long-term health of mothers and babies, potentially guiding future prevention strategies.
What could go wrong
As an observational study, it cannot prove cause and effect. Results may take years to emerge and may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke affiliated ObGyn clinics within Duke Health

    Durham, North Carolina, 27710, United States

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