Happy Mommy! Happy Baby! Study (FAP)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 1506

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Center for Women's Behavioral Wellness
    • Philadelphia, Pennsylvania, United States, 19104
      • 3701 Market Street
    • Philadelphia, Pennsylvania, United States, 19104
      • Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Penn Medicine Washington Square (PMWS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Cynthia N Epperson, M.D., University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Helpful Links

• Program Website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 3, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; stress, psychological; stress, physiological; maternal-fetal relations
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 812880; P50MH099910 (U.S. NIH Grant/Contract)