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NCT02183558 Clinical Trial

Screening for GDM in Women With PCOS and Controls

Polycystic Ovary Syndrome Clinical Trial

Official title:
Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02183558
Other study ID # GDM OBK
Secondary ID Glucose OBK
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date June 2014

Study information
Verified date December 2021
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy, insulin sensitivity decreases. The investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with PCOS and controls.

Recruitment information / eligibility
Status Completed
Enrollment 2500
Est. completion date June 2014
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnancy achieved during 2010-2012 - Residents of the municipality of Odense Exclusion Criteria: - Moving from Odense during pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• OGTT by randomization

• OGTT by indication

Locations
Country Name City State
Denmark OdenseUH Odense

Sponsors (4)
Lead Sponsor Collaborator
Odense University Hospital Municipality of Odense, Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gestational diabetes mellitus Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus. 2 years
Primary Gestational Diabetes Mellitus Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28 Gestational week 28
Secondary Anthropometric measures in offspring The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated At birth
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Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
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Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
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