Effect of Omega-3 Supplementation During Pregnancy on Regulation of Stress (NAPS)
Impact of Omega-3 Intake During Pregnancy on Maternal Stress and Infant Outcome
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Illinois
-
Chicago、Illinois、美国、60637
- University of Chicago
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- African American race
- age between 20 and 34 years
- 16-21 weeks gestation
- household receipt of public assistance (e.g., Medicaid insurance) due to -low-income
- low levels of DHA consumption as defined as less than two fish servings per week.
Exclusion Criteria:
- known medical complications (e.g., gestational diabetes, pre-eclampsia), -regular use of steroid medications
- alcohol use
- cigarettes or use of illegal substances (by maternal report)
- use of blood thinners or anti-coagulants
- use of psychotropic medications
- Body Mass Index >40
- allergy to iodine and/or soy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:DHA supplementation
|
450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
其他名称:
|
安慰剂比较:Soybean Oil
|
soybean oils with strawberry flavoring
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maternal Cortisol Levels
大体时间:Baseline (pre-stressor)
|
Maternal stress regulation at 30 weeks gestation
|
Baseline (pre-stressor)
|
Maternal Cortisol Levels
大体时间:20 minutes post-stressor
|
Maternal stress regulation at 30 weeks gestation
|
20 minutes post-stressor
|
Maternal Cortisol Levels
大体时间:45 minutes post stressor
|
Maternal stress regulation at 30 weeks gestation
|
45 minutes post stressor
|
Infant Cortisol Levels
大体时间:4 months post-partum
|
Infant cortisol response to the Still-Face paradigm before stressor
|
4 months post-partum
|
Infant Cortisol Levels
大体时间:4 months post-partum
|
Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
|
4 months post-partum
|
Infant Cortisol Levels
大体时间:4 months post-partum
|
Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
|
4 months post-partum
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maternal Depression Symptoms
大体时间:16-21 weeks gestation
|
Maternal depression symptoms at 16 to 24 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression. Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. |
16-21 weeks gestation
|
Maternal Depression Symptoms
大体时间:24 weeks
|
Maternal depression symptoms at 24 weeks gestation as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression. Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. |
24 weeks
|
Maternal Depression Symptoms
大体时间:30 weeks gestation
|
Maternal depression symptoms at 30 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression. Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. |
30 weeks gestation
|
Maternal Perceived Stress Scale (PSS) Score
大体时间:Baseline: 16 - 21 weeks
|
Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at baseline. There are 10 questions in this scale and they all refer to typical life stressors. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
Baseline: 16 - 21 weeks
|
Maternal Perceived Stress Scale Score
大体时间:24 weeks gestation
|
Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 24 weeks gestation. There are 10 questions in this scale and they all refer to typical life stressors. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
24 weeks gestation
|
Maternal Perceived Stress Scale Score
大体时间:30 weeks gestation
|
Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 30 weeks gestation. There are 10 questions in this scale and they all refer to typical life stressors. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
|
30 weeks gestation
|
Infant Birth Weight
大体时间:Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Weight of infant
|
Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Percentage of Infants Who Had a 1-minute Apgar Scores of 9
大体时间:Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Percentage of infants who had a 1-minute Apgar scores of 9 Sub scores from 5 categories( Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color) are added together Score range: 1-10 A higher score is better where 7,8,9 are normal
|
Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Gestational Age (GA)
大体时间:Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Gestational Age at time of birth Total sample range: 27.60 to 41.60 weeks Below 37 considered premature Mothers typically induced after 41 weeks due to increased pregnancy risks after this time
|
Time of birth, total sample range: 27.60 to 41.60 weeks gestation
|
Infant's Receptive Communication Scaled Score
大体时间:3 months old
|
Scaled Score on Receptive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child understands spoken words and directions compared to a group of children within the same age range from across the United States. Subscale consists of 49 items. Child'e scaled score is calculated from total raw scores. Scaled score range: 1 - 12 Lower scores indicate more developmental delay. |
3 months old
|
Infant's Expressive Communication Scaled Score
大体时间:At approximately 3 months of age
|
Scaled Score for Expressive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child communicates using sounds, gestures, or words compared to a group of children within the same age range from across the United States. Subscale consists of 48 items. Child'e scaled score is calculated from total raw scores. Scaled score range: 2 - 9 Lower scores indicate more developmental delay. |
At approximately 3 months of age
|
Infant's Fine Motor Skills Scaled Score
大体时间:Approximately 3 months of age
|
Fine motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child recognizes sounds and how much a child can use his or her hands and fingers to do things compared to a group of children within the same age range from across the United States. Subscale consists of 66 items. Child's scaled score is calculated from total raw scores. Scaled score range: 1 - 8 Lower scores indicate more developmental delay. |
Approximately 3 months of age
|
Infant's Gross Motor Skills Scaled Score
大体时间:Approximately 3 months of age
|
Infants Gross Motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child well your child can move his or her body compared to a group of children within the same age range from across the United States. Subscale consists of 72 items. Child's scaled score is calculated from total raw scores. Scaled score range: 1 - 6 'Lower scores indicate more developmental delay. |
Approximately 3 months of age
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 09-190A
- R21HD058269 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Docosahexanoic Acid的临床试验
-
Gladwin, Mark, MDNational Heart, Lung, and Blood Institute (NHLBI); Complexa, Inc.终止
-
University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator招聘中
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)招聘中
-
Critical Outcome Technologies Inc.M.D. Anderson Cancer Center; Northwestern Memorial Hospital未知宫颈癌 | 头颈癌 | 大肠癌 | 胰腺癌 | 卵巢癌 | 输卵管癌 | 肺癌 | 子宫内膜癌 | 腹膜癌 | HNSCC美国