Happy Mommy! Happy Baby! Study

Completed

Conditions studied: Pregnancy, Stress, Psychological, Stress, Physiological, Maternal-fetal Relations

In brief

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.

Key facts

Study ID

NCT01700374

Run by

University of Pennsylvania

People needed

1506

Starts

2012-08-01

Expected to finish

2022-07-01

Last updated by the study team

2023-01-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

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