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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH099910 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies.
Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.
The objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also utilizes an infant stress test to assess infant arousal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women without Prepubertal Adversity | At 8-17 weeks gestational age, 1,500 pregnant women will complete:
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 0 or 1 adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. | ||
| Women with Prepubertal Adversity | At 8-17 weeks gestational age, 1,500 pregnant women will complete:
All women who are screened will be asked if they would be willing to allow the study team to access their delivery report. Women who report 2 or more adverse childhood experiences will be invited to continue in the study as part of the Women without Prepubertal Adversity cohort. We aim to have 125 women in this cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fetal Adrenal Size | The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age. | 20 to 22 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Arousal | The secondary outcomes are physiologic arousal based on the maternal response to the acoustic startle paradigm or TSST plus salivary cortisol at 15-17 weeks gestational age and 6-8 weeks postpartum. | 15 to 21 weeks gestational age and 6 to 8 weeks postpartum |
| Physiologic Arousal |
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Inclusion Criteria:
Exclusion Criteria:
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Women from the greater Philadelphia and surrounding areas who are ages 18 - 45 and between 8 and 17 weeks pregnant will be considered for enrollment into this study. All subjects must be physically healthy without a serious major medical illness, as well as be carrying a healthy fetus. Subjects will be recruited through fliers, advertising, and social media and may be directly approached at a University of Pennsylvania Health System (UPHS) or UPHS affiliated obstetrics and gynecology clinic. We anticipate the composition of the proposed study population to reflect the greater Philadelphia referral base. The projected composition from Philadelphia is African American 42.58%, Hispanic 8.5%, Asian 4.42%, Other 2.04% and White, not of Hispanic Origin, 42.46%.
Additionally, we plan to include father's of the babies that are willing and able to complete the ACE questionnaire.
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia N Epperson, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3701 Market Street | Philadelphia | Pennsylvania | 19104 | United States | ||
| Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27776734 | Result | Morrison KE, Epperson CN, Sammel MD, Ewing G, Podcasy JS, Hantsoo L, Kim DR, Bale TL. Preadolescent Adversity Programs a Disrupted Maternal Stress Reactivity in Humans and Mice. Biol Psychiatry. 2017 Apr 15;81(8):693-701. doi: 10.1016/j.biopsych.2016.08.027. Epub 2016 Aug 26. |
| Label | URL |
|---|---|
| Program Website | View source |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The secondary outcomes are physiologic arousal based on infant stress responses as measured by the infant behavioral assessment and salivary cortisol at 6 months postpartum. |
| 6 months postpartum |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania | 19104 | United States |
| Penn Medicine Washington Square (PMWS) | Philadelphia | Pennsylvania | 19107 | United States |