FAP: Happy Mommy! Happy Baby! Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Women without Prepubertal Adversity At 8-17 weeks gestational age, 1,500 pregnant women will complete: Adverse Childhood Events (ACE) Questionnaire; Perceived Stress Scale (PSS); A general health and demographic questionnaire. 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. |
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| Women with Prepubertal Adversity At 8-17 weeks gestational age, 1,500 pregnant women will complete: Adverse Childhood Events (ACE) Questionnaire; Perceived Stress Scale (PSS); A general health and demographic questionnaire. 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. |
Outcome Measures
Primary Outcome Measures
- Fetal Adrenal Size [20 to 22 weeks gestational age]
The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.
Secondary Outcome Measures
- Physiologic Arousal [15 to 21 weeks gestational age and 6 to 8 weeks postpartum]
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.
- Physiologic Arousal [6 months postpartum]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 to 45 years;
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Able to give written informed consent;
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Between 8 to 17 weeks at time of recruitment;
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Attendance at 20 week ultrasound at a UPHS site;
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Healthy full term (35 6/7 weeks) infants;
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Fluency in written and spoken English.
Exclusion Criteria:
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Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy;
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Presence of a serious medical or neurological illness, requiring treatment during pregnancy;
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Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period;
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Drug or alcohol abuse history within previous 2 years;
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Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder
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Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist;
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Hamilton Depression Rating Scale Score > 14;
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Suicidal ideation within the previous 6 months;
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Use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal;
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A history of preterm birth or history of preterm labor in the active pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 3701 Market Street | Philadelphia | Pennsylvania | United States | 19104 |
| 2 | Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 3 | Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania | United States | 19104 |
| 4 | Penn Medicine Washington Square (PMWS) | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- University of Pennsylvania
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Cynthia N Epperson, M.D., University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 812880
- P50MH099910