Trauma-informed obstetric care to support pregnant women with trauma histories
Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (Buenos Aires, Buenos Aires F.D.) |
| Trial ID | NCT07195058 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Buenos Aires, Buenos Aires F.D.
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.