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Happy Mommy! Happy Baby! Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01700374
Acronym
FAP
Enrollment
1506
Registered
2012-10-04
Start date
2012-08-31
Completion date
2022-07-31
Last updated
2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Fetal Adrenal Size20 to 22 weeks gestational ageThe primary outcome variable is fetal adrenal size as measured by volume (ml) between 20 weeks and 22 weeks gestational age.

Secondary

MeasureTime frameDescription
Physiologic Arousal15 to 21 weeks gestational age and 6 to 8 weeks postpartumThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026