Postpartum Anxiety, Postpartum Depression, Premature Birth, Stress Disorders, Post-Traumatic
Conditions
Brief summary
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Interventions
OTHERDoula Support
Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HUP postpartum patients who are at least 16 years old at the time their newborns' birth * Infant born at HUP * Preterm birth \<34 weeks * English language speaking
Exclusion criteria
* Unable to read or sign informed consent * Parents of infants transferred into HUP NICU * If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks * HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum | 6 months | This will measured by the PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score ranges from 0-80 with 80 being a worse score. |
| Number of participants who have attendance with a primary care provider by 6 months postpartum | 6 months | This will be assessed using the electronic health record and via survey and medical record review of outsider records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Depression scores at 6 months postpartum | 6 months | Edinburgh Postnatal Depression Scale, higher scores reflect higher risk of depression, ranges from 0-30. A score of 13 is indicative of high risk for depression. |
| Receipt of ACOG-recommended postpartum care by patient's designated provider | 12 weeks postpartum | Comparison between two groups, this will be coded as a Yes or No variable |
Countries
United States
Contacts
Primary ContactHeather Burris, MD MPH
Backup ContactNiesha Darden
Outcome results
None listed