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

NCT07195058 | Recruiting

• 1 other identifier: AAAU8914
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mother to Child Transmission; Breast Feeding; Trauma

Keywords

Adverse childhood experiences (ACE); Edinburgh Postnatal Depression Scale (EPDS); Perceived Stress Scale (PSS); Maternal antenatal attachment scale (MAAS); Social Support Questionnaire (SSQ); Prenatal Distress Questionnaire (NuPDQ); Iowa Infant Feeding scale (IIFAS); Trauma Informed Care

Outcome Measures

Primary Outcomes (5)

• Edinburgh Postnatal Depression Scale (EPDS) Score

  Depression and anxiety symptoms during pregnancy will be measured by the EPDS. The scores range from a minimum of 0 to a maximum of 30. The total score reflects the level of depression, with higher scores indicating higher depression.

  8-22 weeks gestation, 28-35 weeks gestation

• Perceived Stress Scale (PSS) Score

  Perceived stress during pregnancy will be measured by the PSS. Scores range from a minimum of 0 to a maximum 40. The total score reflects the level of stress during pregnancy, with higher scores indicating higher stress.

  8-22 weeks gestation, 28- 35 weeks gestation

• Maternal Antenatal Attachment Scale (MAAS) Score

  Maternal Attachment Feelings toward fetus during pregnancy will be measured by the MAAS. Scores range from a minimum of 19 to a maximum of 95. The total score reflects maternal attachment, with higher scores indicating higher maternal-fetal attachment.

  8-22 weeks gestation, 28-35 weeks gestation

• CARE Scale Score

  The mother's experience of care provided will be measured by the CARE Scale. Scores range from a minimum of 10 to a maximum of 50. The total score reflects the level of perceived empathy, with higher scores indicating higher empathy.

  8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birth

• Prenatal Distress Questionnaire (PDQ) Score

  Pregnancy-specific distress will be measured by the PDQ. Scores range from a minimum of 0 to a maximum of 34. The total score reflects the level of prenatal distress, with higher scores indicating higher levels of prenatal stress.

  8-22 weeks gestation, and 28-35 weeks gestation

Secondary Outcomes (4)

• Childbirth Experiences Questionnaire Score

  0-48 hours after birth

• Iowa Infant Feeding Attitudes Scale Score

  0-48 hours after birth

• Gestational Age at Birth

  0-48 hours after birth

• Birthweight

  0-48 hours after birth

Study Arms (2)

Trauma Informed Obstetric Care (TIOC)

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

Behavioral: Trauma Informed Obstetric Care (TIOC)

Treatment as usual (TAU)

NO INTERVENTION

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.

Interventions

Trauma Informed Obstetric Care (TIOC) 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

Trauma Informed Obstetric Care (TIOC)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are \<19 weeks pregnant
• Nulliparous (no previous live births)
• or more years of age
• Carrying a single fetus
• Can speak Spanish

You may not qualify if:

• Any current psychiatric diagnosis or treatment
• Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy

Sponsors & Collaborators

• Columbia University: lead
• Hospital Materno Infantil Ramón Sardá: collaborator

Study Sites (1)

Hospital Materno Infantil Ramon Sardá

Buenos Aires, Buenos Aires F.D., C1246ABQ, Argentina

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Wounds and Injuries

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Pamela Scorza, ScD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Scorza, ScD

CONTACT

646-246-1092; pls2122@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Women's Mental Health in Psychiatry

Model Details: Women will be randomized to intervention (care with clinicians trained in the TIOC model) or control (treatment as usual). Both groups will receive all study evaluations in parallel.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

AR (1)