Happy Mommy! Happy Baby! Study

NCT01700374 | Completed

• 2 other identifiers: 812880P50MH099910
• Study Type: observational
• Target: 1,506
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

pregnancy; stress, psychological; stress, physiological; maternal-fetal relations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physiologic Arousal

  15 to 21 weeks gestational age and 6 to 8 weeks postpartum

• Physiologic Arousal

  6 months postpartum

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

3701 Market Street

Philadelphia, Pennsylvania, 19104, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Medicine Washington Square (PMWS)

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 27776734 RESULT

Related Links

• Program Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Salivary cortisol; * Blood plasma Corticotropin-releasing Hormone (CRH).

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Cynthia N Epperson, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

US (4)