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Evaluating the Effects of Stress in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00525226
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : November 20, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael J. Owens, Emory University

Tracking Information
First Submitted Date September 4, 2007
First Posted Date September 5, 2007
Last Update Posted Date November 20, 2013
Study Start Date September 2007
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2007)
Social and emotional development of infants who have mothers with depression and anxiety, during or soon after pregnancy [ Time Frame: Measured at Year 1 post-pregnancy ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Evaluating the Effects of Stress in Pregnancy
Official Title Perinatal Stress and Gene Influences: Pathways to Infant Vulnerability
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Plasm, serum, and urine samples are processed and stored at each research visit.
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.
  • Depression
  • Panic Disorder
  • Generalized Anxiety Disorder
  • Post-Traumatic Stress Disorder
  • Obsessive Compulsive Disorder (OCD)
Intervention Not Provided
Study Groups/Cohorts 1
Women who have experienced symptoms of depression or anxiety during pregnancy.
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2013)
Original Estimated Enrollment
 (submitted: September 4, 2007)
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Meets DSM-IV criteria for major depressive disorder, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder, or post-traumatic stress disorder
  • Planning pregnancy or less than 16 weeks pregnant by last menstrual period
  • Written and verbal fluency in English
  • Known identity of biological father

Exclusion Criteria:

  • Suicidal or homicidal
  • Psychosis
  • Meets DSM-IV criteria for bipolar disorder, schizophrenia, or an eating disorder
  • Alcohol or substance abuse within 6 months prior to study start date
  • Current illness requiring treatment that can influence outcomes (e.g., epilepsy, asthma, autoimmune disorders)
  • Abnormal thyroid stimulating hormone
  • Anemic
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00525226
Other Study ID Numbers IRB00004249
P50MH077928 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael J. Owens, Emory University
Study Sponsor Emory University
Collaborators National Institute of Mental Health (NIMH)
Principal Investigator: Zachary N. Stowe, MD Emory University
Principal Investigator: Michael J Owens, PhD Emory University
PRS Account Emory University
Verification Date November 2013