Determining Relationships Among Maternity Stress & Sleep

NCT ID: NCT02133963

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

Brief 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

Postpartum Depression; Depression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

women with no history of depression

Non-Probability Sample of women with no history of depression

No interventions assigned to this group

women with a past depression history

Non-Probability Sample of women with a past history of depression

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• nulliparous women in their 2nd trimester of a singleton pregnancy
• women between 18-45 years of age
• women with a past history of depression
• women with no past history of depression

Exclusion Criteria

• under 18 years of age
• over 45 years of age
• pregnancy gestation > 22 weeks at study enrollment
• multiparity
• non-singleton pregnancy
• prior termination of pregnancy at >12 weeks gestation
• prior loss of pregnancy >2 times at <12 weeks gestation
• prior history of stillbirth
• current substance use (alcohol and/or elicit drugs)
• current chronic steroid use
• current use of antidepressants, anti-anxiety medications, mood-stabilizers, psychotropic medications, progesterone treatment, or sleep medications
• current tobacco use
• diagnosed obstructive sleep apnea,
• diagnosed restless legs syndrome (RLS)
• certain cancers
• pre-gestational diabetes
• a body mass index (BMI) of > 40kg/m2 just prior to pregnancy
• chronic hypertension (documented or taking medication for hypertension)
• gestational hypertension
• preeclampsia
• current anemia
• current or past history of psychosis, schizoaffective disorder,or bipolar disorder
• current depression

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Shannon Crowley, PhD

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon K Crowley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Susan S Girdler, PhD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

13-3229

Identifier Type: -

Identifier Source: org_study_id