Trauma-informed Obstetric Care for Perinatal Health in Women With Histories of Childhood Abuse: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Edinburgh Postnatal Depression Scale (EPDS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are <19 weeks pregnant
- •Nulliparous (no previous live births)
- •18 or more years of age
- •Carrying a single fetus
- •Can speak Spanish
排除标准
- •Any current psychiatric diagnosis or treatment
- •Medical complications (hypertension, cardiac disease, diabetes, chronic disease, autoimmune disease) before pregnancy
结局指标
主要结局
Edinburgh Postnatal Depression Scale (EPDS) Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Gestational Age at Birth(0-48 hours after birth)
- Childbirth Experiences Questionnaire Score(0-48 hours after birth)
- Iowa Infant Feeding Attitudes Scale Score(0-48 hours after birth)
- Birthweight(0-48 hours after birth)
研究者
Pamela Scorza
Assistant Professor of Women's Mental Health in Psychiatry
Columbia University