Home-Ultrasound in Routine High-Risk Care of Patients With Gestational Diabetes Mellitus (GDM)
NCT ID: NCT07158970
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-10-01
2027-11-01
Brief Summary
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Detailed Description
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Participants will be randomized to standard care or an intervention group receiving alternating in-person and telemedicine visits with physician-guided home-US using the Pulsenmore device. The primary outcome is patient satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at term. Secondary outcomes include glycemic control, maternal and neonatal outcomes, healthcare utilization, visit duration, and follow-up costs.
The study will enroll 90 women, aged 18-51, with singleton pregnancies and GDM. The study is conducted at the Edith Wolfson Medical Center in Israel over a one-year period. The home-US device is approved for obstetric use and will be used under real-time physician supervision.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home-US Group
Home Ultrasound Monitoring
Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
Standard care
Standard Care Group
Standard high-risk follow up in clinic
No interventions assigned to this group
Interventions
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Use of the Pulsenmore home ultrasound device for fetal assessment, guided remotely by a physician.
Standard care
Eligibility Criteria
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Inclusion Criteria
* GDM diagnosed by OGTT or glucose monitoring
* Hebrew speaking
* Compatible cellphone
Exclusion Criteria
* Fetal anomalies/genetic abnormalities
* Multifetal pregnancy
* Late GDM diagnosis (after 34 weeks)
18 Years
51 Years
FEMALE
No
Sponsors
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PulseNmore
INDUSTRY
Wolfson Medical Center
OTHER_GOV
Responsible Party
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Liat Mor
OBGYN resident
Principal Investigators
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LIat Mor
Role: PRINCIPAL_INVESTIGATOR
Edith Wolfson Medical center
Locations
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Edith Wolfson Medical Center
H̀±olon, Central District, Israel
Countries
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Central Contacts
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Other Identifiers
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0125-25-WOMC
Identifier Type: -
Identifier Source: org_study_id
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