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Happy Mommy! Happy Baby! Study (FAP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700374
First Posted: October 4, 2012
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Fetal Adrenal Size [ Time Frame: 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:
  • Physiologic Arousal [ Time Frame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum ]
    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.

  • Physiologic Arousal [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
  • Salivary cortisol;
  • Blood plasma Corticotropin-releasing Hormone (CRH).

Estimated Enrollment: 1500
Study Start Date: August 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700374


Locations
United States, Pennsylvania
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, 19104
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104
Penn Medicine Washington Square (PMWS)
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Cynthia N Epperson, M.D. University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01700374     History of Changes
Other Study ID Numbers: 812880
P50MH099910 ( U.S. NIH Grant/Contract )
First Submitted: October 2, 2012
First Posted: October 4, 2012
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by University of Pennsylvania:
pregnancy
stress, psychological
stress, physiological
maternal-fetal relations

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms