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

Columbia University

Status: Enrolling

Conditions: Breast Feeding; Trauma; Mother to Child Transmission

Treatments: Behavioral: Trauma Informed Obstetric Care (TIOC)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07195058

AAAU8914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Trauma Informed Obstetric Care (TIOC)

Experimental group

Description:

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

Treatment:

Behavioral: Trauma Informed Obstetric Care (TIOC)

Treatment as usual (TAU)

No Intervention group

Description:

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.