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Comprehensive Postpartum Screening Strategies for Women With Gestational Diabetes Mellitus (GDM)

NCT00849849 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2014-12-18

No results posted yet for this 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 screening for previous gestational diabetic mothers without adequate medical coverage following delivery.

Conditions

  • Diabetes Mellitus, Type 2

Sponsors & Collaborators

  • Woman's

    lead OTHER

Principal Investigators

  • Karen E Elkind-Hirsch, MSc,PhD · Woman's Health Research Institute

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00849849 on ClinicalTrials.gov