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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00921882
Other study ID # 07-084
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2008
Est. completion date May 2013

Study information

Verified date May 2018
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. However, not all women are screened. The objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date May 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Dx of gestational diabetes treated with insulin

- To be in post-partum

- Delivery of a baby of at least 37 weeks of gestation

- Have signed the consent form

Exclusion Criteria:

- History of glucose intolerance of diabetes before the pregnancy

- Obstetrical pathology during pregnancy

Study Design


Intervention

Procedure:
Oral glucose tolerance test
Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.

Locations

Country Name City State
Canada Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral glucose tolerance test Sensitivity, specificity, true and false predictive values of the oral glucose tolerance test 8 weeks post partum
Secondary Acceptability of screening test Prefered moment to do the screening test (48 hours post partum or 8 weeks post partum) 8 weeks post partum
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