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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07195058
Enrollment
60
Registered
2025-09-26
Start date
2025-05-23
Completion date
2027-01-31
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Mother to Child Transmission, 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

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.

Interventions

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

Sponsors

Hospital Materno Infantil Ramón Sardá
CollaboratorNETWORK
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prenatal Distress Questionnaire (PDQ) Score8-22 weeks gestation, and 28-35 weeks gestationPregnancy-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.
Edinburgh Postnatal Depression Scale (EPDS) Score8-22 weeks gestation, 28-35 weeks gestationDepression 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.
Perceived Stress Scale (PSS) Score8-22 weeks gestation, 28- 35 weeks gestationPerceived 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.
Maternal Antenatal Attachment Scale (MAAS) Score8-22 weeks gestation, 28-35 weeks gestationMaternal 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.
CARE Scale Score8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birthThe 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.

Secondary

MeasureTime frameDescription
Iowa Infant Feeding Attitudes Scale Score0-48 hours after birthThe mother's attitudes and attention towards infant feeding will be measured using the Iowa Infant Feeding Attitudes Scale. Scores range from a minimum of 17 to a maximum 85, with a higher score indicating more positive attitudes toward breastfeeding.
Gestational Age at Birth0-48 hours after birthInfant's gestational age at birth.
Birthweight0-48 hours after birthInfant's weight at birth.
Childbirth Experiences Questionnaire Score0-48 hours after birthThe mother's experience of childbirth will be measured with the Childbirth Experiences Questionnaire. The total score ranges from 1 to 4, with 1 indicating positive experiences of childbirth and 4 indicating negative experiences of childbirth.

Countries

Argentina

Contacts

Primary ContactPamela Scorza, ScD
pls2122@cumc.columbia.edu646-246-1092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026