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

Not Applicable

Recruiting

• Conditions: Mother to Child Transmission; Breast Feeding; Trauma

• Registration Number: NCT07195058
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2025-05-23
• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2026-12
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS) Score	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.
Perceived Stress Scale (PSS) Score	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.
Maternal Antenatal Attachment Scale (MAAS) Score	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.
Prenatal Distress Questionnaire (PDQ) Score	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.
CARE Scale Score	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.

Secondary Outcome Measures

Name	Time	Method
Gestational Age at Birth	0-48 hours after birth	Infant's gestational age at birth.
Childbirth Experiences Questionnaire Score	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.
Iowa Infant Feeding Attitudes Scale Score	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.
Birthweight	0-48 hours after birth	Infant's weight at birth.

Trial Locations

Locations (1)

Hospital Materno Infantil Ramon Sardá; 🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina