Happy Mommy! Happy Baby! Study

University of Pennsylvania1,506 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,506

Conditions

Pregnancy Stress, Psychological Stress, Physiological Maternal-fetal Relations

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

3701 Market Street

Philadelphia, Pennsylvania, United States

Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, United States

Penn Medicine Washington Square (PMWS)

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Fetal Adrenal Size

The primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.

Time frame: 20 to 22 weeks gestational age

Secondary Outcomes

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.

Time frame: 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.

Time frame: 6 months postpartum

Data from ClinicalTrials.gov

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