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Evaluation of Risk Factors for Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251559
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
mehmet ozsurmeli, Derince Training and Research Hospital

Brief Summary:
This study examines the relationship between the age at menarche and gestational diabetes mellitus (GDM). In this retrospective study, the sample included all pregnant women diagnosed with GDM in a pregnancy polyclinic in Kocaeli, Turkey between 2014 and 2019. The sample included 373 participants: 233 in the GDM group and 140 in the control group. The groups were compared in terms of age at menarche.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Menstrual Cycle Abnormal Other: oral glucose loading test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of the Relationship Between Age at Menarche and Gestational Diabetes Mellitus
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: patients with gestational diabetes mellitus
study group
Other: oral glucose loading test
oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.

Placebo Comparator: healthy participants
control group
Other: oral glucose loading test
oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.




Primary Outcome Measures :
  1. Gestational diabetes mellitus risk faktors [ Time Frame: From the 24th week of pregnancy to the delivery ]
    It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women with gestational diabetes

Exclusion Criteria:

  • Patients with hypertension and pregestational diabetes mellitus
  • Patients with rheumatologic, nephrological, and hematological diseases
  • Presence of active infection,
  • corticosteroid use, acetylsalicylic acid, and anticoagulant use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251559


Locations
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Turkey
Derince Training and Research Hospital
Kocaeli, Turkey, 1260
Sponsors and Collaborators
Derince Training and Research Hospital
Investigators
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Study Chair: mehmet ozsurmeli Derince Training and Research Hospital
Publications:

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Responsible Party: mehmet ozsurmeli, principal investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04251559    
Other Study ID Numbers: 240785
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by mehmet ozsurmeli, Derince Training and Research Hospital:
menarche
gestational diabetes mellitus
cycle, menstrual
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications