Status:
RECRUITING
Preventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety in Pregnancy
Mood Disorder Due to Specified Medical Condition
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Perinatal mental health disorders are the most prevalent perinatal comorbidity and are associated with the primary cause of maternal mortality in the United States (US) - suicide. Diagnosis of a high-...
Detailed Description
Postpartum mental health disorders disproportionately occur among the 1 million patients with cesarean deliveries (CD) in the United States (US) each year, with 1 in 3 reporting elevated symptoms of p...
Eligibility Criteria
Inclusion
- Pregnant Patients at 22-37 weeks gestation
- Single or multiple gestation
- Nulliparous or multiparous (with prior vaginal or cesarean delivery)
- Antepartum admission for at least 3 days
- High-risk pregnancy due to maternal/fetal comorbidities
- Anticipated cesarean delivery at the University of Colorado
Exclusion
- Lack of capacity to consent
- Medical factors prohibiting participation in the intervention as determined by the inpatient obstetric medical team.
- Anticipated cesarean within 7 days of enrollment
Key Trial Info
Start Date :
October 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06949813
Start Date
October 13 2025
End Date
December 31 2026
Last Update
October 20 2025
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045