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NCT02133963 · ClinicalTrials.gov registry record
Determining Relationships Among Maternity Stress & Sleep
A clinical trial of Depression and Postpartum Depression, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 17
- Enrollment target
- 1
- Study location
NCT02133963 is a study of Depression and Postpartum Depression that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 17 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02133963, a study of Depression and Postpartum Depression, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological mechanisms underlying the relationships among these psychosocial risk factors for PPD, and the development of PPD, remain unclear. However, evidence from non-perinatal populations suggest that dysregulation in stress-reactive neuroendocrine factors may play a role. The primary objectives of this study are: (1) to assess the feasibility of enrolling second trimester pregnant women, with or without depression histories, into a laboratory-based study protocol which includes a mild psychosocial stressor and the collection of venous blood for the measurement of stress-reactive adrenocorticotropic hormone (ACTH) and cortisol; (2) to assess the feasibility of retaining participants, for a brief postpartum phone interview, after completion of the second trimester assessments; and (3) to establish proof of concept for measuring group differences, between women with or without depression histories, in second trimester prenatal measures of neuroendocrine stress reactivity, depressive and anxious symptoms, recent stressful life events, and sleep quality.
Conditions Studied
Study Locations (1)
North Carolina
- UNC Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02133963
The ClinicalTrials.gov registry entry for NCT02133963 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (98% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 0 interventions.
NCT02133963 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02133963 about?
NCT02133963 is a clinical study titled "Determining Relationships Among Maternity Stress & Sleep". Psychosocial factors, including a previous history of depression, recent stressful life events, sleep disturbances during pregnancy, and depression and/or anxiety during pregnancy have been shown to be associated with an increased risk for the development of postpartum depression (PPD). Biological m...
What is the current status of trial NCT02133963?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2014-05. Estimated completion is 2015-05.
What conditions does trial NCT02133963 study?
This clinical trial studies the following conditions: Depression, Postpartum Depression.
Who is sponsoring clinical trial NCT02133963?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02133963 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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