Happy Mommy! Happy Baby! Study
Status: | Active, not recruiting |
---|---|
Conditions: | Psychiatric, Women's Studies |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 10/20/2018 |
Start Date: | August 2012 |
End Date: | July 2019 |
Prepubertal Adversity Effect on Maternal Arousal, Preterm Birth and Infant Stress Response
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.
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.
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.
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.
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.
We found this trial at
4
sites
Philadelphia, Pennsylvania 19104
Principal Investigator: Deborah R Kim, M.D.
Phone: 215-573-8880
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Principal Investigator: Deborah R Kim, M.D.
Phone: 215-573-8880
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
Principal Investigator: Deborah R Kim, M.D.
Phone: 215-573-8880
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Principal Investigator: Deborah R Kim, M.D.
Phone: 215-573-8880
Click here to add this to my saved trials