Home-Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus (GDM)
NCT07158970 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2025-09-18
Summary
This study evaluates the impact of incorporating home-ultrasound (home-US) devices into telemedicine care for patients with gestational diabetes mellitus (GDM). The study will compare satisfaction, clinical outcomes, and healthcare costs between standard high-risk pregnancy care and care augmented by home-US.
Conditions
- Gestational Diabetes Mellitus
Interventions
- DEVICE
-
Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
Standard care
Sponsors & Collaborators
-
PulseNmore
collaborator INDUSTRY -
Wolfson Medical Center
lead OTHER_GOV
Principal Investigators
-
LIat Mor · Edith Wolfson Medical center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 51 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-08-31
- Completion
- 2027-11-01
Countries
- Israel
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