Recruiting

Trauma-Informed Obstetric Care for Women with Childhood Abuse Histories

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What is being tested

Trauma Informed Obstetric Care (TIOC)

Behavioral
Who is being recruted

Behavior+1

+ Breast Feeding

+ Feeding Behavior

From 18 to 45 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorColumbia University
Study ContactPamela Scorza, ScD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 23, 2025

Actual date on which the first participant was enrolled.

The study focuses on enhancing care for pregnant women who have experienced childhood trauma, as these women and their babies face higher risks for health and developmental issues. This is especially significant for low-income women, who are more likely to encounter such trauma, perpetuating health and economic inequalities. The research aims to evaluate a new approach where obstetricians are trained to provide care that is sensitive to the needs of these women. By implementing this trauma-informed care model in a public hospital in Argentina, the study seeks to improve outcomes for both mothers and infants. Participants in the study will receive care from obstetric clinicians who have been specially trained in trauma-informed obstetric care. This means the clinicians will use techniques and approaches that consider the past trauma of the women and aim to reduce stress during pregnancy and childbirth. The study will observe the effects of this approach on the health and development of the infants, as well as the well-being of the mothers, although specific outcomes to be measured are not detailed in the study description. The goal is to see if this sensitive approach to care can lead to better health results for women and their children.

Official TitleTrauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
NCT07195058
Principal SponsorColumbia University
Study ContactPamela Scorza, ScD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBreast FeedingFeeding BehaviorWounds and Injuries

Criteria

5 inclusion criteria required to participate
Women who are <19 weeks pregnant

Nulliparous (no previous live births)

18 or more years of age

Carrying a single fetus

Show More Criteria

2 exclusion criteria prevent from participating
Any current psychiatric diagnosis or treatment

Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Women randomized to the trauma informed obstetric care (TIOC) intervention will be scheduled for all their prenatal appointments with obstetricians trained in the TIOC model. Additionally, the midwife on duty in the delivery ward will ensure that all items on a checklist of trauma-sensitive birth practices are followed during that participant's labor and delivery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Materno Infantil Ramon Sardá

Buenos Aires, ArgentinaOpen Hospital Materno Infantil Ramon Sardá in Google Maps
Recruiting
One Study Center