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Can social support lower preterm birth risk? new study investigates

NCT ID NCT05229666

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how stress and social support might influence preterm birth in 200 pregnant women, especially among Black and Hispanic women who face higher risks. Researchers will measure stress levels, immune responses, and cellular energy (mitochondria) to understand why stress may lead to earlier delivery. The goal is to find ways to use social support to reduce preterm birth risk.

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
If successful, this could help identify women at higher risk for preterm birth due to stress and point to social support as a way to reduce that risk.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly prevent preterm birth. Results may not apply to all populations or lead to immediate changes in care.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

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

Started

Dec 2021

Expected to finish

Dec 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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * Pregnant women 18 years of age or older (based on self-report) * Not currently smoking, drinking alcohol, or taking drugs (based on self-report) * Planning to deliver at CUIMC/NYP (based on self-report) * In the first or second trimester of pregnancy (prior to 28 weeks gestation) (based on self-report of estimated date of delivery) Exclusion Criteria * Multi-fetal pregnancy (based on self-report) * Taking medications regularly that affect the cardiovascular and inflammatory systems, including NSAIDS and other anti-inflammatories, α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2- adrenoceptor agonists) (based on self-report) * This does NOT include baby aspirin or low-dose aspirin, as baby aspirin / low-dose aspirin is not normally considered to be an NSAID. * Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis (based on self-report)

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Conditions

The condition(s) this trial relates to.

Inflammation inflammatory disease Premature Birth

As listed by the trial registrant

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

Inflammation Mental health issue Preterm birth Stress

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

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