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Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Meeting the Needs of Pregnant Women With PTSD in Prenatal Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02807662
Enrollment
149
Registered
2016-06-21
Start date
2012-02-29
Completion date
2015-06-30
Last updated
2016-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder, prenatal care

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.

Interventions

BEHAVIORALAdapted Seeking Safety Intervention

Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.

Sponsors

Health Resources and Services Administration (HRSA)
CollaboratorFED
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in posttraumatic stress disorder symptomsThe primary endpoint is one month postpartum
Preterm laborthe primary endpoint is one month postpartum
Birthweightthe primary endpoint is one month postpartum

Secondary

MeasureTime frame
Number of visits for prenatal carethe primary end point is one month postpartum
Change in depression symptomsthe primary endpoint is one month postpartum
change in coping strategies inventorythe primary endpoint is one month postpartum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026