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NCT Number: NCT07195058

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

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.

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Key information

Conditions

Mother to Child Transmission Behavior Breast Feeding Feeding Behavior Trauma Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Materno Infantil Ramon Sardá

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

Location status: Recruiting

Location contact

Sergio Casini

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • Effects of trauma on physiological and psychological process relevant to pregnancy and childbirth.
  • Body language and verbal language for safety, respect, and patient agency
  • Recognizing and responding to distress and dissociation

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS) Score

    Time frame: 8-22 weeks gestation, 28-35 weeks gestation

    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.

  2. Perceived Stress Scale (PSS) Score

    Time frame: 8-22 weeks gestation, 28- 35 weeks gestation

    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.

  3. Maternal Antenatal Attachment Scale (MAAS) Score

    Time frame: 8-22 weeks gestation, 28-35 weeks gestation

    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.

  4. CARE Scale Score

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

    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.

  5. Prenatal Distress Questionnaire (PDQ) Score

    Time frame: 8-22 weeks gestation, and 28-35 weeks gestation

    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.

Secondary outcomes

  1. Childbirth Experiences Questionnaire Score

    Time frame: 0-48 hours after birth

    The 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.

  2. Iowa Infant Feeding Attitudes Scale Score

    Time frame: 0-48 hours after birth

    The 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.

  3. Gestational Age at Birth

    Time frame: 0-48 hours after birth

    Infant's gestational age at birth.

  4. Birthweight

    Time frame: 0-48 hours after birth

    Infant's weight at birth.

Study contacts

Contact information is provided by the study sponsor or research team.

Pamela Scorza, ScD

CONTACT

[email protected]

646-246-1092

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Hospital Materno Infantil Ramón Sardá

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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