Determining Relationships Among Maternity Stress & Sleep

Completed

Conditions studied: Postpartum Depression, Depression

In brief

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.

Key facts

Study ID

NCT02133963

Run by

University of North Carolina, Chapel Hill

People needed

17

Starts

2014-05-01

Expected to finish

2015-05-01

Last updated by the study team

2015-05-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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