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临床试验/NCT02807662
NCT02807662已完成不适用

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

University of Massachusetts, Worcester0 个研究点目标入组 149 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
主要终点
Preterm labor

研究概览

简要总结

The objectives of this research study are to screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

详细描述

Studies of Posttraumatic Stress Disorder (PTSD) in pregnant women in public payer settings have shown rates 5 or more times that of other populations, and rates as high as 33% of lifetime PTSD sub-threshold symptoms. PTSD during pregnancy has been linked to poor prenatal care and high risk behaviors such as drug and alcohol use and smoking. Further, PTSD may pose a barrier to care as obstetric procedures and pregnancy may trigger PTSD symptoms and avoidance of care. PTSD is also associated with pregnancy and birth complications and negative postpartum outcomes including excessive weight gain, preterm birth, low birth weight, risk for parenting problems, and increased barriers to breastfeeding. However, screening, identification, and support for PTSD is lacking. This study will screen 750 pregnant women at risk of trauma-related stress symptoms, and adapt and test an evidence-based intervention for pregnant women with PTSD and sub-threshold PTSD symptoms served by two public payer community health centers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Mothers who are receiving prenatal care
  • 18 years or older
  • In the first 20 weeks of pregnancy
  • Screen positive for posttraumatic stress disorder

排除标准

  • Not pregnant
  • Not currently psychotic
  • No current suicidal ideation
  • Language other than English, Spanish, Vietnamese, and Portuguese

结局指标

主要结局

Preterm labor

时间窗: the primary endpoint is one month postpartum

Change in posttraumatic stress disorder symptoms

时间窗: The primary endpoint is one month postpartum

Birthweight

时间窗: the primary endpoint is one month postpartum

次要结局

  • Change in depression symptoms(the primary endpoint is one month postpartum)
  • Number of visits for prenatal care(the primary end point is one month postpartum)
  • change in coping strategies inventory(the primary endpoint is one month postpartum)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Weinreb

Principal Investigator

University of Massachusetts, Worcester

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