Happy Mommy! Happy Baby! Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response

Conditions
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Pregnancy, Stress, Psychological, Stress, Physiological, Maternal-fetal Relations

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 45 years; Able to give written informed consent; Between 8 to 17 weeks at time of recruitment; Attendance at 20 week ultrasound at a UPHS site; Healthy full term (35 6/7 weeks) infants; Fluency in written and spoken English. Exclusion Criteria: Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy; Presence of a serious medical or neurological illness, requiring treatment during pregnancy; Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period; Drug or alcohol abuse history within previous 2 years; Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist; Hamilton Depression Rating Scale Score > 14; Suicidal ideation within the previous 6 months; Use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal; A history of preterm birth or history of preterm labor in the active pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women without Prepubertal Adversity<br>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. | |
| Women with Prepubertal Adversity<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, stress, psychological, stress, physiological, maternal-fetal relations