What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Remote Medical Model (RMM), Community Health Model (CHM), or SoC. The registry lists allocation as randomized. The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications.
They plan to enroll about 6,030 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension
Interventions: Remote Medical Model (RMM), Community Health Model (CHM), SoC
Primary outcome (registry wording): Change in mean postpartum systolic blood pressure (SBP) at 6 weeks