EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS.
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| ClinicalTrials.gov Identifier: NCT02035995 |
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Recruitment Status :
Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
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Sponsor:
Kayseri Education and Research Hospital
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | January 11, 2014 | ||
| First Posted Date | January 14, 2014 | ||
| Last Update Posted Date | January 14, 2014 | ||
| Study Start Date | January 2013 | ||
| Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Retinal evaluation [ Time Frame: 6 weeks ] The aim of this study was to determine retinal findings of gestational diabetes mellitus (GDM).
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| Original Primary Outcome Measures | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS. | ||
| Official Title | EVALUATION OF THE MACULAR, PERIPAPILLARY NERVE FIBER LAYER AND CHOROID THICKNESS CHANGES IN THE GESTATIONAL DIABETES MELLITUS, HEALTHY PREGNANT AND WOMEN VOLUNTEERS. | ||
| 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 Type | Observational [Patient Registry] | ||
| Study Design | Observational Model: Case-Crossover Time Perspective: Prospective |
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| Target Follow-Up Duration | 6 Weeks | ||
| Biospecimen | Retention: None Retained Description: no biospecimens are to be retained
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| Sampling Method | Non-Probability Sample | ||
| Study Population | Community sample | ||
| Condition | Retinal Evaluation in Patients With GDM. | ||
| Intervention | Other: Pregnant volunteers with GDM | ||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
76 | ||
| Original Actual Enrollment | Same as current | ||
| Actual Study Completion Date | July 2013 | ||
| Actual Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria: Singleton pregnancies Pregnancies between 26-28 weeks of gestation Gestational Diabetes Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 45 Years (Adult) | ||
| Accepts Healthy Volunteers | Yes | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Turkey | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT02035995 | ||
| Other Study ID Numbers | GokhanAcmaz | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Gökhan Açmaz, Kayseri Education and Research Hospital | ||
| Study Sponsor | Kayseri Education and Research Hospital | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Kayseri Education and Research Hospital | ||
| Verification Date | January 2014 | ||