- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01158976
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
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: DHA supplementation
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450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
다른 이름들:
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위약 비교기: Soybean Oil
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soybean oils with strawberry flavoring
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maternal Cortisol Levels
기간: Baseline (pre-stressor)
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Maternal stress regulation at 30 weeks gestation
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Baseline (pre-stressor)
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Maternal Cortisol Levels
기간: 20 minutes post-stressor
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Maternal stress regulation at 30 weeks gestation
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20 minutes post-stressor
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Maternal Cortisol Levels
기간: 45 minutes post stressor
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Maternal stress regulation at 30 weeks gestation
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45 minutes post stressor
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Infant Cortisol Levels
기간: 4 months post-partum
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Infant cortisol response to the Still-Face paradigm before stressor
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4 months post-partum
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Infant Cortisol Levels
기간: 4 months post-partum
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Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor
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4 months post-partum
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Infant Cortisol Levels
기간: 4 months post-partum
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Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
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4 months post-partum
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Maternal Depression Symptoms
기간: 16-21 weeks gestation
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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
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Maternal Depression Symptoms
기간: 24 weeks
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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
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Maternal Depression Symptoms
기간: 30 weeks gestation
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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
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Maternal Perceived Stress Scale (PSS) Score
기간: Baseline: 16 - 21 weeks
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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.
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Baseline: 16 - 21 weeks
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Maternal Perceived Stress Scale Score
기간: 24 weeks gestation
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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.
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24 weeks gestation
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Maternal Perceived Stress Scale Score
기간: 30 weeks gestation
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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.
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30 weeks gestation
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Infant Birth Weight
기간: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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Weight of infant
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Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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Percentage of Infants Who Had a 1-minute Apgar Scores of 9
기간: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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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
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Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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Gestational Age (GA)
기간: Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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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
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Time of birth, total sample range: 27.60 to 41.60 weeks gestation
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Infant's Receptive Communication Scaled Score
기간: 3 months old
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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
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Infant's Expressive Communication Scaled Score
기간: At approximately 3 months of age
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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
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Infant's Fine Motor Skills Scaled Score
기간: Approximately 3 months of age
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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
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Infant's Gross Motor Skills Scaled Score
기간: Approximately 3 months of age
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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
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 09-190A
- R21HD058269 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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