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Clinical Trials/NCT02807662
NCT02807662
Completed
N/A

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

University of Massachusetts, Worcester0 sites149 target enrollmentFebruary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
University of Massachusetts, Worcester
Enrollment
149
Primary Endpoint
Preterm labor
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
June 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Linda Weinreb

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Preterm labor

Time Frame: the primary endpoint is one month postpartum

Change in posttraumatic stress disorder symptoms

Time Frame: The primary endpoint is one month postpartum

Birthweight

Time Frame: the primary endpoint is one month postpartum

Secondary Outcomes

  • 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)

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