Trauma-informed Obstetric Care for Perinatal Health: a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trauma Informed Obstetric Care (TIOC).
- Who it may be relevant to
- Registry conditions: Mother to Child Transmission, Breast Feeding, Trauma. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
Overview
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
- Behavioral Trauma 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
Primary outcome measures
- Edinburgh Postnatal Depression Scale (EPDS) Score [Time frame: 8-22 weeks gestation, 28-35 weeks gestation]
- Perceived Stress Scale (PSS) Score [Time frame: 8-22 weeks gestation, 28- 35 weeks gestation]
- Maternal Antenatal Attachment Scale (MAAS) Score [Time frame: 8-22 weeks gestation, 28-35 weeks gestation]
- CARE Scale Score [Time frame: 8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birth]
- Prenatal Distress Questionnaire (PDQ) Score [Time frame: 8-22 weeks gestation, and 28-35 weeks gestation]
Secondary outcome measures (4)
- Childbirth Experiences Questionnaire Score [Time frame: 0-48 hours after birth]
- Iowa Infant Feeding Attitudes Scale Score [Time frame: 0-48 hours after birth]
- Gestational Age at Birth [Time frame: 0-48 hours after birth]
- Birthweight [Time frame: 0-48 hours after birth]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Argentina · 1 center
- Hospital Materno Infantil Ramon Sardá — Buenos Aires
Identifiers
NCT: NCT07195058 · AAAU8914