EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.

Completed

• Conditions: Retinal Evaluation in Patients With GDM.
• Interventions: Other: Pregnant volunteers with GDM

• Registration Number: NCT02035995
• Lead Sponsor: Kayseri Education and Research Hospital

Brief Summary

Gestational diabetes mellitus (GDM) is a risk factor for the development of type II diabetes and it is responsible for the morbidity of both mother and child. The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).

Detailed Description

We have three groups; the first group consisted of pregnant volunteers with GDM. The second group consisted of healthy pregnant participants. The third group consisted of healthy, non-pregnant women at the reproductive age. Macular, choroid and retinal nerve fiber layer (RNFL) thicknesses were evaluated in patients with GDM and comparisons were made among GDM, healthy pregnant and healthy non-pregnant subjects for these parameters by using optic cohorence tomography.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-11
• Study First Submitted QC: 2014-01-11
• Last Update Submitted: 2014-01-11
• Study First Posted: 2014-01-14
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Singleton pregnancies Pregnancies between 26-28 weeks of gestation Gestational Diabetes

Exclusion Criteria

• ocular surgery ocular trauma glaucoma cystoid macular edema macular degeneration optic atrophy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy pregnant volunteers	Pregnant volunteers with GDM	This group consisted of age matched healthy pregnant volunteers
Healthy volunteers	Pregnant volunteers with GDM	This group consisted of age matched non-pregnant healthy volunteers

Primary Outcome Measures

Name	Time	Method
Retinal evaluation	6 weeks	The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).

Trial Locations

Locations (1)

Kayseri Education and Research Hospital; 🇹🇷 Kayseri, Turkey