Evaluating the Effects of Stress in Pregnancy
Condition: Depression; Panic Disorder; Generalized Anxiety Disorder; Post-Traumatic Stress Disorder; Obsessive Compulsive Disorder (OCD)
MeSH terms: Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Panic Disorder
Study type: Observational

Summary: 
      This study will evaluate pregnant women with a past or current diagnosis of depression or
      anxiety to gain a better understanding of how these disorders can affect an infant's
      development, both during and after pregnancy.
    

Detailed description: 
      Depression and anxiety are serious conditions affecting millions of people each year. In
      fact, it is estimated that approximately one in every four women will be treated for a mood
      disorder, such as depression or anxiety, at some point in her life. As effective treatment
      options continue to develop, many women diagnosed with depression or anxiety are able to
      resume normal lives and may choose to become pregnant. However, studies suggest that the
      intrauterine environment can be altered by maternal stress, depression, and anxiety, which
      may affect the fetus during pregnancy. Also, antidepressant medications have been known to
      cause complications for both the mother and fetus, which can make pregnancy a very difficult
      time for women with a history of depression and anxiety. These women are more prone to
      relapse during pregnancy, even if they previously recovered from the disorder. The purpose of
      this study is to evaluate whether symptoms of depression and anxiety, during or soon after
      pregnancy, affect an infant's social and emotional development.

      Participation in this study will occur from early in the woman's pregnancy until her infant's
      first birthday. Participants will attend at least eight study visits during pregnancy and
      five study visits during the first year of the infant's life. Most study visits will take
      place at the Emory University clinic on campus. During the first study visit, participants
      will complete questionnaires regarding their current mood, stressors, supports, experiences
      during pregnancy, symptoms of depression or anxiety, and any treatment or medications they
      are currently receiving. Urine and blood will also be collected at the initial visit.
      Follow-up visits, lasting 1 hour, will occur monthly until delivery. During these visits,
      similar questionnaires will be administered and blood, urine, and saliva samples will be
      collected. Uterine blood flow, fetal activity, and fetal heart rate will be recorded at some
      follow-up visits. Women who undergo an amniocentesis will have the option of providing a
      sample of amniotic fluid and an additional blood sample.

      Immediately after delivery, blood from the baby's umbilical cord and blood from the mother
      will be collected. A week after delivery, a home visit will be scheduled to assess each
      mother's mood, stress, supports, delivery complications, and first impressions of the new
      baby. At this time, a behavioral assessment will also be conducted on each infant, and
      mothers will be observed while interacting with their child. At the infant's 6-month
      pediatrician visit, a saliva sample will be taken to measure levels of cortisol and other
      indicators of stress. Infants will be assessed at three other times before their first
      birthday. During these assessments, the infant's ability to regulate his or her emotions will
      be evaluated by videotaped behavioral observations, stress hormones from saliva, heart rate,
      or recordings of brain activity through the use of either an electroencephalogram (EEG) or
      event related potentials (ERP). Lastly, participants will be given the option to provide a
      DNA sample for further analysis and future research. Fathers of the babies will be included
      in selected study visits. Results from this study will be used to help prevent emotional and
      social developmental problems in infants whose mothers have been diagnosed with either
      depression or anxiety.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women of child bearing potential between the ages of 18 to 45 years of age with or without
        a history of depression or anxiety disorders.
      
Biospecimen description: 
      Plasm, serum, and urine samples are processed and stored at each research visit.
    
Keywords: Psychiatry; Psychology; Pregnancy; Stress; Anxiety