- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: DHA supplementation
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450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
Autres noms:
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Comparateur placebo: Soybean Oil
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soybean oils with strawberry flavoring
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maternal Cortisol Levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 4 months post-partum
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Infant cortisol response to the Still-Face paradigm 45 mins post-stressor
|
4 months post-partum
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maternal Depression Symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
24 weeks gestation
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Maternal Perceived Stress Scale Score
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 09-190A
- R21HD058269 (Subvention/contrat des NIH des États-Unis)
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