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NCT06666400 · ClinicalTrials.gov registry record · NA
Living Healthy for Moms RCT
A NA study of Postpartum Depression (PPD) and Cardiac Event, sponsored by Columbia University.
- Active
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT06666400: Active NA study of Postpartum Depression (PPD) and Cardiac Event, sponsored by Columbia University.
NCT06666400 is a NA study of Postpartum Depression (PPD) and Cardiac Event that is active but no longer recruiting, run by Columbia University. The registered enrollment target is 21 participants, below the 461-participant average among 4 other Postpartum Depression (PPD) trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06666400, a NA study of Postpartum Depression (PPD) and Cardiac Event, is active but no longer recruiting, sponsored by Columbia University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to prevent long-term physical and mental health sequelae.
Primary Outcome
The primary outcome of PPD, operationalized as the presence or absence of postpartum depressive symptoms, is defined by EPDS score (≥9). EPDS ≥9 was chosen specifically because that is the score used as the cut-off to refer for clinical evaluation, and the rate of EPDS ≥9 ranges from about 30-40% depending on other characteristics of the clinics. Assuming 1:1 randomization, a design effect of 1.5 to account for variance among sites and doulas, a power of 0.80, a two-sided significance level of 0
Conditions Studied
Interventions
- OTHER No intervention
- BEHAVIORAL LHMoms Intervention
Study Locations (4)
New York
- New York Presbyterian Brooklyn Methodist Hospital - Brooklyn
- New York City Health + Hospitals/ Queens - Jamaica
- NewYork-Presbyterian Allen Hospital - New York
- Weill Cornell Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2025-01-17 |
| Est. Completion | 2030-06-01 |
| Phase | NA |
What the registry record for NCT06666400 still lists
NCT06666400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 461-participant average among 4 other Postpartum Depression (PPD) trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Postpartum Depression (PPD) appearing as the primary indexed condition, and to 2 interventions - of which No intervention is the first listed.
NCT06666400 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06666400 about?
NCT06666400 is a clinical study titled "Living Healthy for Moms RCT". LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critica...
What is the current status of trial NCT06666400?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2025-01-17. Estimated completion is 2030-06-01.
What conditions does trial NCT06666400 study?
This clinical trial studies the following conditions: Postpartum Depression (PPD), Cardiac Event.
What interventions are being tested in trial NCT06666400?
The interventions under investigation include: No intervention (OTHER), LHMoms Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06666400?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06666400 being conducted?
This trial has 4 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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