Clinical trial NCT01700374: Happy Mommy! Happy Baby! Study
Official title: Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Stress, Psychological
Stress, Physiological
Maternal-fetal Relations
Keywords: pregnancy
stress, psychological
stress, physiological
maternal-fetal relations
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-10-04
Enrollment: 1506
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Fetal Adrenal Size
timeFrame: 20 to 22 weeks gestational age
Secondary outcomes:
measure: Physiologic Arousal
timeFrame: 15 to 21 weeks gestational age and 6 to 8 weeks postpartum
measure: Physiologic Arousal
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: 3701 Market Street
state: Pennsylvania
city: Philadelphia
country: United States
facility: Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Center for Women's Behavioral Wellness
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine Washington Square (PMWS)
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Cynthia N Epperson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.