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OpenTrials
Completed

NCT Number: NCT01700374

Happy Mommy! Happy Baby! Study

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

3701 Market Street, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: FAP

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2012
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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