Screening for GDM in Women With PCOS and Controls

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02183558

Collaborator

Region of Southern Denmark (Other), Municipality of Odense (Other), University of Southern Denmark (Other)

2,500

Enrollment

Location

Arms

Duration (Months)

47.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Gestational Diabetes Mellitus	Other: OGTT by randomization Other: OGTT by indication	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OGTT by randomization Women without risk factors for GDM are offered OGTT in gestational week 28	Other: OGTT by randomization
Experimental: OGTT by indication Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28	Other: OGTT by indication

Arm

Intervention/Treatment

Experimental: OGTT by randomization

Women without risk factors for GDM are offered OGTT in gestational week 28

Other: OGTT by randomization

Experimental: OGTT by indication

Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28

Other: OGTT by indication

Outcome Measures

Primary Outcome Measures

Gestational diabetes mellitus [2 years]
Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.
Gestational Diabetes Mellitus [Gestational week 28]
Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28

Secondary Outcome Measures

Anthropometric measures in offspring [At birth]
The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated