Happy Mommy! Happy Baby! Study

Pregnancy Clinical Trial

— FAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700374
• Other study ID #: 812880
• Secondary ID: P50MH099910
• Status: Completed
• Start date: August 2012
• Est. completion date: July 2022

Study information

• Verified date: January 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1506
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
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 Center for Women's Behavioral Wellness	Philadelphia	Pennsylvania
United States	Penn Medicine Washington Square (PMWS)	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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.2016.08.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Program Website