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NCT06915259 · ClinicalTrials.gov registry record · NA
Doula Model of Care
A NA study of Mental Health and Morbidity, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 230
- Enrollment target
- 1
- Study location
NCT06915259: Recruiting NA study of Mental Health and Morbidity, sponsored by University of Pennsylvania.
NCT06915259 is a NA study of Mental Health and Morbidity that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 230 participants, below the 10,180-participant average among 62 other Mental Health trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06915259, a NA study of Mental Health and Morbidity, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 230 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people. The main question it aims to answer is whether an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people, assessed by the primary outcome of depression score. Participants will be randomized to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.
Primary Outcome
Scores from the validated EPDS screening tool will be calculated using standard scoring criteria for each of the 10 items. A score of 9 or greater or indication of suicide ideation will be used to indicate a positive depression screen
Conditions Studied
Interventions
- OTHER Doula Model of Care
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2026-03 |
| Phase | NA |
What NCT06915259 shows while recruiting
NCT06915259 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 10,180-participant average among 62 other Mental Health trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Mental Health appearing as the primary indexed condition, and to 1 intervention - of which Doula Model of Care is the first listed.
NCT06915259 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06915259 about?
NCT06915259 is a clinical study titled "Doula Model of Care". The goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people. The main qu...
What is the current status of trial NCT06915259?
This trial is currently recruiting. It is a NA study. The enrollment target is 230 participants. The study started on 2025-04-16. Estimated completion is 2026-03.
What conditions does trial NCT06915259 study?
This clinical trial studies the following conditions: Mental Health, Morbidity, Perinatal.
What interventions are being tested in trial NCT06915259?
The interventions under investigation include: Doula Model of Care (OTHER).
Who is sponsoring clinical trial NCT06915259?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06915259 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06915259's enrollment target sits among peer trials
230 33rd of 62 higher than 30 of 62 other Mental Health trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mental Health trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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