NCT03751813终止不适用
Baby Bump Lifestyle Intervention Supplement Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- lower blood stress markers via venous draw
研究概览
简要总结
The overall purpose of this study is to examine how natural supplements can mediate the effects of stress on fetal development during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman presenting to her first obstetrical visit for this pregnancy
- •Must be in the first trimester (<13 weeks)
- •18 years or older
- •High-stress levels as measured by the Perceived Stress Level Questionnaire
- •Must be a single pregnancy (e.g. not twins, triplets, etc.)
排除标准
- •Diabetes (types 1 and 2)
- •Diagnosis of gestational diabetes in prior pregnancy
- •Hyperemesis gravidarum or severe morning sickness that interferes with supplement intake
- •Major medical illnesses including but not limited to: malabsorption syndromes (Celiac's disease, Crohn's, Ulcerative Colitis), Systemic Lupus Erythematosus and other major autoimmune conditions
结局指标
主要结局
lower blood stress markers via venous draw
时间窗: 9 months
We hypothesize that the addition of nutrients during gestation will decrease the levels of stress hormones/reactants in pregnant women who are at high risk for stressful pregnancies.
次要结局
未报告次要终点
研究者
Kai Ling Kong
Principal Investigator
State University of New York at Buffalo
研究点 (2)
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