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New program aims to help moms after preterm birth

NCT ID NCT05120843

Knowledge-focused Sponsor: Children's Hospital of Philadelphia 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a care coordination and motivational interviewing program for women who recently had a preterm birth. The goal was to see if the program was feasible and acceptable to participants. Only 13 women enrolled before the study was terminated, so the findings are very preliminary.

What this could mean

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

Active substance
care coordination and motivational interviewing
What this could lead to
If successful, this approach could improve follow-up care and health outcomes for women after a preterm birth.
What could go wrong
This was a very small, early feasibility study that was terminated, so results are limited and may not apply to larger 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

13 people

The number who actually took part.

Started

Feb 2022

Finished

Sep 2023

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

14 to 45 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. Female 2. Less than 45 years old 3. History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs) 4. Intention to seek pediatric care at one of two pediatric primary care sites 5. Medicaid insurance Exclusion Criteria: 1. History of sterilization procedure. 2. Plan to move away from the area or transfer pediatric primary care within six months of enrollment. 3. Limited English proficiency

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Conditions

The condition(s) this trial relates to.

Birth Weight Contraception Behavior Depression depressive disorder nicotine dependence Patient Acceptance of Health Care Premature Birth Tobacco Use

As listed by the trial registrant

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

Contraceptive usage Depression Health care utilization Preterm birth Tobacco use Weight, birth

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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