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New toolkit aims to make pregnancy care safer for trauma survivors

NCT ID NCT06654427

Knowledge-focused Sponsor: The Miriam Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

Many pregnant women have experienced trauma, which can make prenatal care stressful and increase health risks. This study will create and test a toolkit to train obstetric providers in trauma-informed care, including screening tools and modified procedures. Researchers will work with patients, nurses, and doctors to ensure the toolkit is practical and helpful. The goal is to improve the care experience and health outcomes for trauma survivors during pregnancy and postpartum.

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 165 people

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

Started

Jul 2025

Expected to finish

Jun 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 to 99 years

Sex

Anyone

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 for pregnant and postpartum patients for individual interviews: * ≥ 18 years old * under the care of an obstetrician or nurse practitioner in the U.S., * English-speaking * have had ≥2 prenatal care encounters, and postpartum if they delivered a surviving infant within the past 12 months * received care at either of the pilot sites during the pilot trial. * Pregnant and postpartum participants will be eligible for the trauma-exposed group if they * report a history of trauma in childhood or adulthood, * are ≥1 year from the time of the traumatic experience * are not currently at-risk for harm from self or others * are willing to discuss experiences related to trauma and are able to do so without experiencing undue distress. * Patient participants will be eligible for the non-trauma group if they deny trauma. Inclusion criteria for provider participants: * Practicing physicians or nurses * ≥ 6 months of experience in obstetrics * English speaking * Clinician Participants (providers in the participating clinics) will be enrolled in the pilot trial of the obstetric trauma-informed care toolkit intervention. * Clinician participants will be enrolled for group or individual interviews if they consent to do so and meet above criteria. Exclusion Criteria: Patient participants will be excluded from the study interviews if they report * a current unsafe environment (determined by the Assessment of Immediate Safety) * report suicidal ideation (as determined by the PHQ9) * report difficulty discussing experiences related to trauma. Provider participants will be excluded from the study if they do not work at one of the pilot clinics. Provider participants will be excluded from the study interviews if they do not consent to be interviewed.

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Conditions

The condition(s) this trial relates to.

injury pregnancy disorder

As listed by the trial registrant

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

Obstetrics trauma Pregnancy related Trauma

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • The Miriam Hospital

    Providence, Rhode Island, 02903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.