- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148897
Awareness of Gestational Diabetes Among Sohag Governorate Women
Study of Awareness of Gestational Diabetes Problem Among Sohag Governorate Women
The type of the study is a cross sectional descriptive using questionnaire method in Sohag governorate among 500 Women, over 6 months by random selection and they will be asked to answer the questions of prepared and copied questionnaire sheet.
Inclusion criteria: all women can participate in this questionnaire.
Study Overview
Detailed Description
the study is a cross sectional descriptive using questionnaire method in Sohag governorate among 500 women, over 6 months by random selection and they will be asked to answer the questions of prepared and copied questionnaire sheet. Data was collected by using a self-administered questionnaire. Based on extensive literature review no questionnaire was found that specifically related to knowledge evaluation. The basic theme of the questionnaire was taken from Diabetes Knowledge Questionnaire (DKN), a well validated tool for knowledge assessment among type 1 and type 2 diabetes mellitus patients. Some modifications were made and new questions particularly related to Gestational Diabetes Mellitus (GDM) were included. Final version of questionnaire consists of 15questions divided into five main categories which are basic knowledge about GDM(3 questions), risk factors (3 questions), food and diet values (3 questions), management(3 questions)and complications/outcomes (3 questions). All questions were in multiple choice format with one option was "I don't know "to avoid unnecessary guesses by the participants. Score 1 was given to every right answer and 0 to every wrong answer. A higher score indicates better knowledge about GDM. Thus the maximum score is 15 and minimum is 0 and other questions without score to know the patient himself and to assess the relationship between the residency, work, education level and knowledge of patient and family history.
A standardized questionnaire will focus on:
- Personal Data
- Basic Knowledge about GDM
- Knowledge about risk factors of GDM
- Knowledge about diet/food values
- Knowledge about management of GDM
- Knowledge about GDM complications/outcomes
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eslam E Mohamed Fawzy, Doctor
- Phone Number: 0109 386 0560
- Email: eslam.emad8275@gmail.com
Study Contact Backup
- Name: Hamdy s Mohamed, Ass.Prof
- Phone Number: 01111101934
- Email: hamdy119@yahoo.com
Study Locations
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Sohag, Egypt
- Recruiting
- Sohag University
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Contact:
- Eslam E awesh, doctor
- Phone Number: 0109 386 0560
- Email: eslam.emad8275@gmail.com
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Principal Investigator:
- Eslam E Mohamed Fawzy, doctor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All Females
Exclusion Criteria:
- There is no Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
All Women can participate
among 500 women, over 6 months by random selection and they will be asked to answer the questions of prepared and copied questionnaire sheet.
|
a self-administered questionnaire.
Based on extensive literature review no questionnaire was found that specifically related to knowledge evaluation.
The basic theme of the questionnaire was taken from Diabetes Knowledge Questionnaire (DKN), a well validated tool for knowledge assessment among type 1 and type 2 diabetes mellitus patients.
Some modifications were made and new questions particularly related to GDM were included.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate general knowledge of women about different aspects of Gestational Diabetes: Questionnaire
Time Frame: Change the literacy of knowledge of women about different aspects of Gestational Diabetes at 6 months after the questionnaire
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All the statistical analysis will be done by using Statistical Package for Social Sciences (SPSS Inc., Chicago, IL) version20.
Number and percentage will be used for grouped variables whereas mean and standard deviation will be used for continuous variables.
Responses to all questions of the questionnaire will be recorded in numbers and percentages.
Association of demographic characteristics with knowledge score
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Change the literacy of knowledge of women about different aspects of Gestational Diabetes at 6 months after the questionnaire
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Adel A Elsayed, Prof, Professor doctor at department of Internal medicine
Publications and helpful links
General Publications
- Atlas, D.J.I.D.A., 9th: International Diabetes Federation, International diabetes federation. 2020
- Eltoony, L.F., et al., Prevalence and Risk Factors for Gestational Diabetes in Aswan, Egypt According to International Association of the Diabetes and Pregnancy Study Groups (IADPSG). 2021. 82(4): p. 701-707.
- O'Sullivan EP, Avalos G, O'Reilly M, Dennedy MC, Gaffney G, Dunne F; Atlantic DIP collaborators. Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria. Diabetologia. 2011 Jul;54(7):1670-5. doi: 10.1007/s00125-011-2150-4. Epub 2011 Apr 15. Erratum In: Diabetologia. 2016 Apr;59(4):873.
- Farrar D. Hyperglycemia in pregnancy: prevalence, impact, and management challenges. Int J Womens Health. 2016 Sep 20;8:519-527. doi: 10.2147/IJWH.S102117. eCollection 2016.
- Metzger BE, Coustan DR. Summary and recommendations of the Fourth International Workshop-Conference on Gestational Diabetes Mellitus. The Organizing Committee. Diabetes Care. 1998 Aug;21 Suppl 2:B161-7. No abstract available.
- Khan R, Bisnath J, Blackmann J, Bissessar R, Bidhesi S, Boodoo N, Bobb T, Benjamin J, Mohammed A, Mahabir A. Prevalence rates of impaired glucose tolerance and gestational diabetes mellitus amongst expectant mothers and undiagnosed diabetes mellitus in walk-in patients at health centres in North Central Trinidad. J Family Med Prim Care. 2020 Jun 30;9(6):3112-3118. doi: 10.4103/jfmpc.jfmpc_124_20. eCollection 2020 Jun.
- Muche AA, Olayemi OO, Gete YK. Prevalence and determinants of gestational diabetes mellitus in Africa based on the updated international diagnostic criteria: a systematic review and meta-analysis. Arch Public Health. 2019 Aug 6;77:36. doi: 10.1186/s13690-019-0362-0. eCollection 2019.
- Hegazi R, El-Gamal M, Abdel-Hady N, Hamdy O. Epidemiology of and Risk Factors for Type 2 Diabetes in Egypt. Ann Glob Health. 2015 Nov-Dec;81(6):814-20. doi: 10.1016/j.aogh.2015.12.011.
- Cavanaugh KL. Health literacy in diabetes care: explanation, evidence and equipment. Diabetes Manag (Lond). 2011 Mar;1(2):191-199. doi: 10.2217/dmt.11.5.
- Lee KW, Ching SM, Ramachandran V, Yee A, Hoo FK, Chia YC, Wan Sulaiman WA, Suppiah S, Mohamed MH, Veettil SK. Prevalence and risk factors of gestational diabetes mellitus in Asia: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2018 Dec 14;18(1):494. doi: 10.1186/s12884-018-2131-4.
- Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, Dietz PM. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007 Aug;30(8):2070-6. doi: 10.2337/dc06-2559a. Epub 2007 Apr 6.
- Cheung NW. The management of gestational diabetes. Vasc Health Risk Manag. 2009;5(1):153-64. doi: 10.2147/vhrm.s3405. Epub 2009 Apr 8.
- Hussain Z, Yusoff ZM, Sulaiman SA. Evaluation of knowledge regarding gestational diabetes mellitus and its association with glycaemic level: A Malaysian study. Prim Care Diabetes. 2015 Jun;9(3):184-90. doi: 10.1016/j.pcd.2014.07.007. Epub 2014 Aug 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-21-11-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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