Awareness of Gestational Diabetes Among Sohag Governorate Women

Gestational Diabetes Clinical Trial

Official title:

Study of Awareness of Gestational Diabetes Problem Among Sohag Governorate Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148897
• Other study ID #: Soh-Med-21-11-05
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: Eslam E Mohamed Fawzy, Doctor
• Phone: 0109 386 0560
• Email: eslam.emad8275[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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:

1. Personal Data

2. Basic Knowledge about GDM

3. Knowledge about risk factors of GDM

4. Knowledge about diet/food values

5. Knowledge about management of GDM

6. Knowledge about GDM complications/outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• All Females

Exclusion Criteria:

• There is no Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Atlas, D.J.I.D.A., 9th: International Diabetes Federation, International diabetes federation. 2020

Cavanaugh KL. Health literacy in diabetes care: explanation, evidence and equipment. Diabetes Manag (Lond). 2011 Mar;1(2):191-199. — View Citation

Cheung NW. The management of gestational diabetes. Vasc Health Risk Manag. 2009;5(1):153-64. Epub 2009 Apr 8. Review. — View Citation

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. Epub 2007 Apr 6. — View Citation

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.

Farrar D. Hyperglycemia in pregnancy: prevalence, impact, and management challenges. Int J Womens Health. 2016 Sep 20;8:519-527. eCollection 2016. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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 wa — View Citation

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 1 — View Citation

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. — View Citation

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- — View Citation

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) — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate general knowledge of women about different aspects of Gestational Diabetes: Questionnaire	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	Change the literacy of knowledge of women about different aspects of Gestational Diabetes at 6 months after the questionnaire