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App aims to cut preterm birth risk by helping moms space pregnancies

NCT ID NCT04663607

Prevention Sponsor: Stanford University Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested whether a mobile app called PretermConnect could help women who had a preterm baby reduce the risk of having another preterm birth. The app provides health education and tracks things like pregnancy spacing and mental health. 221 women with a preterm baby in the NICU took part. The goal was to see if the app improves care and outcomes compared to standard paper-based methods.

What this could mean

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

Active substance
PretermConnect mobile app
What this could lead to
If it works, this could offer a simple, low-cost way to help women avoid another preterm birth by improving pregnancy spacing and care.
What could go wrong
This is a completed trial, but the approach relies on app engagement, which may not work for everyone. Results may not apply to all 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.

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

221 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2025

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

16 to 50 years

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: 1. Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play. 2. Participants must consent to the study. 3. Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm. 4. Women 16-50 years of age 5. Women who can read, write and understand English Site-specific additional recruitment criteria 1. UPMC Children's Hospital of Pittsburgh: Mothers whose babies have been in the neonatal intensive care unit for more than one month. 2. UPMC Magee-Womens Hospital: Mothers who have had a preterm baby of \<36 weeks. Exclusion Criteria: 1. For this initial study, those who do not have a mobile phone will be excluded. (This exclusion will not affect the inclusion of minorities as minorities Internet use via mobile platforms is equal to or greater than whites; hence we are not excluding minorities, based on the PEW Research Center study (PEW Internet Spring Tracking Survey, April 17-May 19, 2013)). 2. Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Preterm birth

Contacts and locations

Locations

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

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