Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07195058

Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study

Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Columbia University · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The study will test trauma-informed obstetric care training and supervision for obstetric clinicians in relation to prenatal mental health and attachment formation (early predictors of child development) in women presenting for prenatal care in a public hospital in Buenos Aires, Argentina.

Detailed description

Infants of women who have experienced trauma have up to five times the risk of health and developmental problems. Low-income women are more likely to experience trauma, a factor in the intergenerational transmission of racial and socioeconomic inequities in health and development. In women with trauma histories, pregnancy and the period after the baby is born can be particularly stressful. A new way of improving pregnancy and early childhood outcomes in women with trauma histories is to train obstetric clinicians in the delivery of obstetric care attuned to the unique needs of women with histories of childhood abuse. Models of trauma-informed obstetric and gynecological care (TIOC) have been developed, however, none of these TIOC models have been formally tested for effectiveness. This study aims to develop and test a model of TIOC in a public hospital in Argentina that serves women who experience a high degree of disadvantage.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTrauma Informed Obstetric Care (TIOC)TIOC providers will receive a training that was developed for this study. Elements of trauma-informed care described in the literature -combined with the experience of the study team, with deep expertise in trauma-informed obstetric care, were used to create three training modules, each of which includes didactics and role-plays to help participants practice and embody skills they learn. The three modules are: 1. Effects of trauma on physiological and psychological process relevant to pregnancy and childbirth. 2. Body language and verbal language for safety, respect, and patient agency 3. Recognizing and responding to distress and dissociation

Timeline

Start date
2025-05-23
Primary completion
2026-12-01
Completion
2027-01-01
First posted
2025-09-26
Last updated
2025-09-26

Locations

1 site across 1 country: Argentina

Source: ClinicalTrials.gov record NCT07195058. Inclusion in this directory is not an endorsement.