BUMPP: A Study to Better Understand Mood During the Perinatal Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Self-report questionnaire measure of manic symptoms (Highs Scale)
研究概览
简要总结
The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •35 weeks pregnant or less
- •carrying only one baby (not twins or triplets)
- •first time giving birth
- •can speak/read/write in English
排除标准
- •major medical health condition like a heart, kidney, or liver disease or HIV
- •currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study
- •have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)
结局指标
主要结局
Self-report questionnaire measure of manic symptoms (Highs Scale)
时间窗: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
Mother-infant behavior during 5 min play episode coded using Global Rating Scales
时间窗: 2 months postpartum
Assessed at in-person laboratory session (session 4)
Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)
时间窗: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90)
时间窗: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7)
时间窗: 35 weeks of pregnancy through 2 months postpartum
Assessed at each of 4 sessions
Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development
时间窗: 2 months postpartum
Assessed at in-person laboratory session (session 4)
次要结局
- Monthly cortisol levels determined from hair sample(35 weeks of pregnancy through 2 months postpartum)
- Cytokine levels determined from finger prick blood spot(35 weeks of pregnancy through 2 months postpartum)