Trauma-informed obstetric care to support pregnant women with trauma histories
Official title: Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
Run by Columbia University · NCT07195058 · Data updated 2026-11-12
This project will try trauma-informed obstetric care training for clinicians to see if it helps pregnant women with past trauma improve prenatal mental health and early bonds with their babies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires F.D.) |
| Status | Recruiting |
| Started | May 23, 2025 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT07195058 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women presenting for care at Hospital Materno Infantil Ramón Sardá in Buenos Aires who are 18 or older, less than 19 weeks pregnant, nulliparous, carrying a single fetus, and fluent in Spanish.
✕Probably not a fit
Women with a current psychiatric diagnosis or treatment, preexisting medical complications (such as hypertension, diabetes, cardiac or autoimmune disease), multiparous women, non-Spanish speakers, or those presenting after 19 weeks are not eligible and therefore unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Infants of women with trauma histories face higher risks of health and developmental problems, and low-income women are disproportionately affected. This pilot implements trauma-informed obstetric care (TIOC) training and supervision for obstetric clinicians at a public hospital in Buenos Aires. Eligible pregnant women seen by trained clinicians will be followed from early pregnancy and screened with standard measures such as the EPDS, PSS, MAAS, SSQ and ACEs to track prenatal mental health and maternal–fetal attachment. The project aims to test feasibility, acceptability, and initial signals of benefit compared with usual care in this disadvantaged population.
Why it matters
Potential benefit: If successful, this approach could improve prenatal mental health and strengthen early maternal–infant attachment among women with trauma histories, potentially reducing risk of later child developmental problems.
How similar studies have gone: Models of trauma-informed obstetric and gynecological care have been developed, but none have been formally tested for effectiveness, so this represents a novel formal test.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who are \<19 weeks pregnant * Nulliparous (no previous live births) * 18 or more years of age * Carrying a single fetus * Can speak Spanish Exclusion Criteria: * Any current psychiatric diagnosis or treatment * Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy
Where it's running
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Hospital Materno Infantil Ramon Sardá
Buenos Aires, Buenos Aires F.D., Argentina Recruiting
Study contacts
- Principal investigator: Pamela Scorza, ScD — Columbia University
- Study coordinator: Pamela Scorza, ScD
- Email: pls2122@cumc.columbia.edu
- Phone: 646-246-1092
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.