Clinical trial NCT02807662: Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
Official title: Meeting the Needs of Pregnant Women With PTSD in Prenatal Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
prenatal care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2016-06-21
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in posttraumatic stress disorder symptoms
timeFrame: The primary endpoint is one month postpartum
measure: Preterm labor
timeFrame: the primary endpoint is one month postpartum
measure: Birthweight
timeFrame: the primary endpoint is one month postpartum
Secondary outcomes:
measure: Number of visits for prenatal care
timeFrame: the primary end point is one month postpartum
measure: Change in depression symptoms
timeFrame: the primary endpoint is one month postpartum
measure: change in coping strategies inventory
timeFrame: the primary endpoint is one month postpartum
Other outcomes:
Locations:
Study officials:
References:
citation: Weinreb L, Wenz-Gross M, Upshur C. Postpartum outcomes of a pilot prenatal care-based psychosocial intervention for PTSD during pregnancy. Arch Womens Ment Health. 2018 Jun;21(3):299-312. doi: 10.1007/s00737-017-0794-x. Epub 2017 Nov 7.