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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02290860 |
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Date of registration:
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10/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus
SoL |
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Scientific title:
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Screening Type 2 Diabetes Mellitus on the 2nd Day After Delivery in Women With Gestational Diabetes Mellitus - Stage 2, a Multicentre Trial. |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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228 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02290860 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Jean-Luc Ardilouze, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women aged between 18 and 45 years;
- Having a positive diagnosis of gestational diabetes mellitus (GDM) (IADPSG or CDA
criteria or patient followed for GDM);
- Treated with diet, insulin or oral hypoglycemic agents;
- Have given birth to a child at term (gestational age = 37 weeks);
- Have signed the consent form.
Exclusion Criteria:
- History of glucose intolerance or diabetes before the pregnancy;
- Have presented another obstetrical pathology during the pregnancy;
- Severe gestational high blood pressure with proteinuria;
- Delayed intrauterine development syndrome;
- Pregnancy with more than a foetus;
- Drug addiction;
- Had complications during the delivery such as:
- Moderate to severe postpartum bleeding;
- Surgery in postpartum (curettage, hysterectomy, etc.).
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Diabetes, Gestational
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Intervention(s)
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Procedure: Type 2 diabetes diagnosis test
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Primary Outcome(s)
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abnormal glucose tolerance
[Time Frame: 8 weeks after delivery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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