Evaluating the Effects of Stress in Pregnancy
Recruitment status was Recruiting
|First Received Date ICMJE||September 4, 2007|
|Last Updated Date||June 27, 2011|
|Start Date ICMJE||September 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00525226 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluating the Effects of Stress in Pregnancy|
|Official Title ICMJE||Perinatal Stress and Gene Influences: Pathways to Infant Vulnerability|
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.
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 ICMJE||Observational|
|Study Design ICMJE||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|
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.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||1
Women who have experienced symptoms of depression or anxiety during pregnancy.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||750|
|Estimated Completion Date||July 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 45 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00525226|
|Other Study ID Numbers ICMJE||P50 MH077928, DDTR B3-PDB|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Zachary N. Stowe, MD, Principal Investigator, Emory University|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Mental Health (NIMH)|
|Verification Date||March 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP