跳至主要内容
临床试验/NCT01912833
NCT01912833已完成不适用

Assessing the Association Between Stressful Life Events, Hormonal Dysregulation, and Postpartum Depression Among Lactating Latina Mothers: A Pilot Study

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Postpartum depression

研究概览

简要总结

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. 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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Postpartum depression

时间窗: third trimester to 12 weeks postpartum

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandraluz Lara-Cinisomo, PhD

Postdoctoral Fellow

University of North Carolina, Chapel Hill

研究点 (1)

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