Happy Mommy! Happy Baby! Study

Completed

• Conditions: Stress, Physiological; Pregnancy; Stress, Psychological; Maternal-fetal Relations

• Registration Number: NCT01700374
• Lead Sponsor: University of Pennsylvania

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1506

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (4)

Penn Center for Women's Behavioral Wellness; 🇺🇸 Philadelphia, Pennsylvania, United States

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 Medicine Washington Square (PMWS); 🇺🇸 Philadelphia, Pennsylvania, United States