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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Edinburgh Postnatal Depression Scale (EPDS) Score [Срок оценки: 8-22 weeks gestation, 28-35 weeks gestation]
• Perceived Stress Scale (PSS) Score [Срок оценки: 8-22 weeks gestation, 28- 35 weeks gestation]
• Maternal Antenatal Attachment Scale (MAAS) Score [Срок оценки: 8-22 weeks gestation, 28-35 weeks gestation]
• CARE Scale Score [Срок оценки: 8-22 weeks gestation, 28-35 weeks gestation, 0-48 hours after birth]
• Prenatal Distress Questionnaire (PDQ) Score [Срок оценки: 8-22 weeks gestation, and 28-35 weeks gestation]

Вторичные конечные точки (4)

• Childbirth Experiences Questionnaire Score [Срок оценки: 0-48 hours after birth]
• Iowa Infant Feeding Attitudes Scale Score [Срок оценки: 0-48 hours after birth]
• Gestational Age at Birth [Срок оценки: 0-48 hours after birth]
• Birthweight [Срок оценки: 0-48 hours after birth]

Критерии участия

Критерии включения

• Women who are <19 weeks pregnant
• Nulliparous (no previous live births)
• 18 or more years of age
• Carrying a single fetus
• Can speak Spanish

Критерии исключения

• Any current psychiatric diagnosis or treatment
• Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Аргентина · 1 центр

• Hospital Materno Infantil Ramon Sardá — Buenos Aires

Идентификаторы

NCT: NCT07195058 · AAAU8914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗