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Clinical Trials/NCT00774124
NCT00774124
Completed
Not Applicable

Improving Outcomes in Underserved Women With GDM

Temple University2 sites in 1 country57 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Temple University
Enrollment
57
Locations
2
Primary Endpoint
maternal blood glucose control
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.

Detailed Description

Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
July 2010
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of GDM
  • 33 or less weeks gestation

Exclusion Criteria

  • multiple gestations
  • history of glucose intolerance outside of pregnancy

Outcomes

Primary Outcomes

maternal blood glucose control

Time Frame: 3 to 9 months

Secondary Outcomes

  • infant birthweight(at delivery)

Study Sites (2)

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