Study of Exposure to Stress, Postpartum Mood, Adverse Life Events, and Hormonal Function Among Latinas (SEPAH Latina) (SEPAH)
Assessing the Association Between Stressful Life Events, Hormonal Dysregulation, and Postpartum Depression Among Lactating Latina Mothers: A Pilot Study
調査の概要
状態
条件
詳細な説明
Study Objective: The purpose of the funded study is to determine a) examine associations among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess whether there are differences between immigrant women and non-immigrant Latina women on these measures; b) quantify whether there is a correlation between ACTH, cortisol, and PPD and whether there are differences between immigrant and non-immigrant Latina women; and c) assess the feasibility of enrolling Latinas into a laboratory-based study that includes the collection of venous blood for measurement of oxytocin, ACTH, and cortisol.
Research Aims: 1) To examine associations among OT levels, stress, trauma history, PPD, and lactation failure in the full 60-subject sample and assess whether there are differences between immigrant women and non-immigrant Latina women on these measures; 2) To quantify whether there is a correlation between ACTH, cortisol, and PPD and whether there are differences between immigrant and non-immigrant Latina women; 3) To assess the feasibility of enrolling Latinas into a laboratory-based study that includes the collection of venous blood for measurement of oxytocin, ACTH, and cortisol; and 4) Assess the performance of the Spanish language protocol and measures to identify barriers to implementation and address needed modifications prior to large-scale implementation.
Subjects: Sixty prenatal (34 to 37 weeks) Latinas (30 immigrants and 30 U.S.-born) who are between the ages of 18 and 45 will be enrolled. Women with a singleton pregnancy who are Latina, who intend to breastfeed for more than 2 months, who have or do not have a history of depression, and who are willing to be followed for 8 weeks after delivery will be enrolled in the study. Latinas who report maternal or infant disorder that may interfere with breastfeeding; those who endorse substance use, and/or who have or have had a psychiatric disorder (e.g., psychosis or serious personality disorders) other than depression or anxiety will be excluded to minimize risk and confounds with the outcomes of interest.
Methods: There will be four study-time points: prenatal visit, 4- and 12-weeks postpartum phone interviews, and one laboratory visit at 8-weeks postpartum. Participants will be compensating after each interview.
Prenatal Visit: We will collect demographic information; assess depression and anxiety status, as well as breastfeeding intention. During the prenatal visit we will also inquire about acculturation and everyday stressors. English and Spanish validated measures will be used.
Postpartum Phone Interviews: We will inquire about breastfeeding practices and self-efficacy using the Breastfeeding Self-Efficacy-Short Form as well as depression status using the EPDS.
Laboratory Visit: At 8 weeks postpartum, biomarkers will be collected via blood draws during breastfeeding and the cold pressor stress test. Oxytocin will be collected during breastfeeding and adrenocorticotropic hormone (ACTH) and cortisol will be collected after a recovery period and during the cold pressor stress test. Childhood and Border-Crossing Trauma will be collected following the laboratory procedures.
What will be gained: This study will enable us to begin to understand Latinas (immigrant and U.S.-born) neuroendocrine responses to high levels of stress, which will enable us to and determine associations between stress and trauma the development of postpartum depression. This study will also enable us to identify risk factors for postpartum depression among immigrant and U.S.-born Latinas.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27516
- University of North Carolina, Chapel Hill
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Prenatal Latina/Hispanic women 34 to 37 weeks
- Latina/Hispanic women 18 and 45 years of age
- Latina/Hispanic women with a singleton pregnancy
- Latina/Hispanic women who intend to breastfeed for more than 2 months
- Latina/Hispanic women who are willing to be followed for 16 weeks
Exclusion Criteria:
- Latina/Hispanic women who report maternal or infant disorder that may interfere with breastfeeding
- Latina/Hispanic women who endorse substance use (alcohol and/or elicit drugs)
- Latina/Hispanic women who have or have had a psychiatric disorder (e.g., psychosis or serious personality disorders) other than depression or anxiety
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postpartum depression
時間枠:third trimester to 12 weeks postpartum
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Postpartum depression will be assessed using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire that helps to identify women who have postpartum depression.
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third trimester to 12 weeks postpartum
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協力者と研究者
捜査官
- 主任研究者:Sandraluz Lara-Cinisomo, Ph.D.、UNC Chapel Hill
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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