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Determining Relationships Among Maternity Stress & Sleep

NCT02133963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2015-05-19

No results posted yet for this 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

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Shannon K Crowley, PhD · University of North Carolina, Chapel Hill

  • Susan S Girdler, PhD · University of North Carolina, Chapel Hill

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02133963 on ClinicalTrials.gov