Improving Outcomes in Underserved Women With GDM
- Conditions
- PregnancyDiabetes Mellitus
- Registration Number
- NCT00774124
- Lead Sponsor
- Temple University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 57
- diagnosis of GDM
- 33 or less weeks gestation
- multiple gestations
- history of glucose intolerance outside of pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method maternal blood glucose control 3 to 9 months
- Secondary Outcome Measures
Name Time Method infant birthweight at delivery
Trial Locations
- Locations (2)
Tallahassee Memorial Diabetes Center
🇺🇸Tallahassee, Florida, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Tallahassee Memorial Diabetes Center🇺🇸Tallahassee, Florida, United States