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

NCT ID: NCT07195058

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2027-01-31

Brief 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

Mother to Child Transmission; Breast Feeding; Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Trauma Informed Obstetric Care (TIOC)

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

Group Type: EXPERIMENTAL

Trauma Informed Obstetric Care (TIOC)

Intervention Type: BEHAVIORAL

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

Treatment as usual (TAU)

Participants randomized to TAU will receive usual prenatal care, which includes a referral to psychological services when deemed necessary by the prenatal care provider. These participants' prenatal visits will not be scheduled with providers who have received TIOC training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Trauma 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Materno Infantil Ramón Sardá

NETWORK

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Scorza

Assistant Professor of Women's Mental Health in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Scorza, ScD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Hospital Materno Infantil Ramon Sardá

Buenos Aires, Buenos Aires F.D., Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Pamela Scorza, ScD

Role: CONTACT

pls2122@cumc.columbia.edu

646-246-1092

Other Identifiers

AAAU8914

Identifier Type: -

Identifier Source: org_study_id