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Evaluation of Risk Factors for Gestational Diabetes Mellitus

Primary Purpose

Diabetes, Gestational, Menstrual Cycle Abnormal

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral glucose loading test
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes, Gestational focused on measuring menarche, gestational diabetes mellitus, cycle, menstrual

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Derince Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

patients with gestational diabetes mellitus

healthy participants

Arm Description

study group

control group

Outcomes

Primary Outcome Measures

Gestational diabetes mellitus risk faktors
It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2020
Last Updated
January 29, 2020
Sponsor
Derince Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04251559
Brief Title
Evaluation of Risk Factors for Gestational Diabetes Mellitus
Official Title
Evaluation of the Relationship Between Age at Menarche and Gestational Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Menstrual Cycle Abnormal
Keywords
menarche, gestational diabetes mellitus, cycle, menstrual

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with gestational diabetes mellitus
Arm Type
Active Comparator
Arm Description
study group
Arm Title
healthy participants
Arm Type
Placebo Comparator
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
oral glucose loading test
Intervention Description
oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.
Primary Outcome Measure Information:
Title
Gestational diabetes mellitus risk faktors
Description
It was evaluated whether the menarche age of pregnant women with gestational diabetes was different from pregnancy without gestational diabetes.
Time Frame
From the 24th week of pregnancy to the delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehmet ozsurmeli
Organizational Affiliation
Derince Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Derince Training and Research Hospital
City
Kocaeli
ZIP/Postal Code
1260
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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Evaluation of Risk Factors for Gestational Diabetes Mellitus

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