Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,506
- 试验地点
- 4
- 主要终点
- Fetal Adrenal Size
研究概览
简要总结
The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies.
Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.
详细描述
The objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also utilizes an infant stress test to assess infant arousal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 18 to 45 years;
- •Able to give written informed consent;
- •Between 8 to 17 weeks at time of recruitment;
- •Attendance at 20 week ultrasound at a UPHS site;
- •Healthy full term (35 6/7 weeks) infants;
- •Fluency in written and spoken English.
排除标准
- •Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy;
- •Presence of a serious medical or neurological illness, requiring treatment during pregnancy;
- •Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period;
- •Drug or alcohol abuse history within previous 2 years;
- •Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder
- •Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist;
- •Hamilton Depression Rating Scale Score > 14;
- •Suicidal ideation within the previous 6 months;
- •Use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal;
- •A history of preterm birth or history of preterm labor in the active pregnancy.
结局指标
主要结局
Fetal Adrenal Size
时间窗: 20 to 22 weeks gestational age
The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
次要结局
- Physiologic Arousal(6 months postpartum)