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NCT00849849 · ClinicalTrials.gov registry record
Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)
A clinical trial, sponsored by Woman's.
- Completed
- Registry status
- 214
- Enrollment target
NCT00849849: Completed study, sponsored by Woman's.
NCT00849849 is a clinical trial that has completed, run by Woman's. The registered enrollment target is 214 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00849849 has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- 214 participants
- Enrollment target
Study Summary
Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a history of GDM vary widely depending on the length of follow up and the underlying risk of diabetes in the population. Like DM2, the incidence of postpartum diabetes appears to be increasing The cumulative incidence of DM2 varied from 2.6 to \> 70% in studies with postpartum follow-up ranging from 6 weeks to 28 years. Among women with a history of gestational diabetes, it is generally accepted that race, age, parity, family history of diabetes, pre-pregnancy weight, postpartum obesity, and weight gain are risk factors for developing DM2. Other suspected risk factors include smoking, physical inactivity, diet, and drugs that adversely affect glucose metabolism. Despite the high and increasing rate of DM2 in Louisiana, the medical community does not have reliable estimates of the number of woman living in southern Louisiana who develop diabetes subsequent to GDM. At Woman's Hospital, the investigators had 8246 deliveries in 2007; 7873 mothers (95% of deliveries) were either African American or Caucasian. Of this group of women, 665 were diagnosed with gestational diabetes mellitus. Thus, around 8.5% of the African American and Caucasian women delivering babies at Woman's Hospital in 2007 had a glucose abnormality. The incidence of diabetes and impaired glucose metabolism in the immediate postpartum period and within 12 months after delivery in this population is unknown. There are no long-term studies performed in Louisiana that have compared the benefits of different screening strategies or evaluated an optimum testing frequency after GDM to reduce the rate of DM2 and cardiovascular disease (CVD) in these high-risk women. The investigators plan to use this study as an outreach effort to provide screen
Primary Outcome
A 2 hr, 75-gram OGTT with measurements of insulin and glucose will be performed at their 6-12 week and 1-year post-delivery check-up; this will be compared with the results of their single fasting glucose and insulin value.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-12 |
What the finished NCT00849849 record still lists
NCT00849849 is an observational study that tracks outcomes without assigning an intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00849849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00849849 about?
NCT00849849 is a clinical study titled "Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)". Previous gestational diabetes (GDM) predisposes affected women to diabetes. Pregnancy, in essence, serves as a metabolic stress test and uncovers underlying insulin resistance and ß-cell dysfunction. Cumulative incidence rates of type 2 diabetes (DM2) among women with a history of GDM vary widely de...
What is the current status of trial NCT00849849?
This trial is currently completed. The enrollment target is 214 participants. The study started on 2011-07. Estimated completion is 2013-12.
Who is sponsoring clinical trial NCT00849849?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
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