Gestational DiabetesNCT05148897
Awareness of Gestational Diabetes Among Sohag Governorate Women
An observational study of Gestational Diabetes, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: cross sectional descriptive using questionnaire method in Sohag governorate among 500Women, over 6 months by random selection
Who may be able to join
- All Females
Who cannot join
- There is no Exclusion Criteria:
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Eslam E awesh, doctor, 0109 386 0560, eslam.emad8275@gmail.com
Eslam E Mohamed Fawzy, doctor
About this study
Official title: 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.
Read the 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
- Conditions
- Gestational Diabetes
- Being tested
- Questionnaire
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change the literacy of knowledge of women about different aspects of Gestational Diabetes at 6 months after the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Oct 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Emad Mohamed, Sohag University
- Investigators
- Adel A Elsayed, Prof, Study chair, Professor doctor at department of Internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148897
- Sponsor's protocol ID
- Soh-Med-21-11-05
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: knowledge of women about different aspects of Gestational Diabetes Mellitus including general knowledge about the disease, risk factors, diet in diabetic patients and complications among the women in Sohag governorate ad the questionnaire itself
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.
PubMed 21494772Farrar 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.
PubMed 27703397Metzger 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.
PubMed 9704245Khan 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.
PubMed 32984182Muche 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.
PubMed 31402976Hegazi 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.
PubMed 27108148Cavanaugh 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.
PubMed 21860659Lee 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.
PubMed 30547769Chu 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.
PubMed 17416786Cheung NW. The management of gestational diabetes. Vasc Health Risk Manag. 2009;5(1):153-64. doi: 10.2147/vhrm.s3405. Epub 2009 Apr 8.
PubMed 19436673Hussain 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.
PubMed 25132140
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Awareness of Gestational Diabetes Problem Among Sohag Governorate Women
- ClinicalTrials.gov ID
- NCT05148897
- Acronym / sponsor ID
- Soh-Med-21-11-05
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Women can participate | – | Other: Questionnaireamong 500 women, over 6 months by random selection and they will be asked to answer the questions of prepared and copied questionnaire sheet. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cross sectional descriptive using questionnaire method in Sohag governorate among 500Women, over 6 months by random selection
Key inclusion criteria (1 listed)
- All Females
Key exclusion criteria (1 listed)
- There is no Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnairea 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. | Other | All Women can participate |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- BackgroundAtlas, D.J.I.D.A., 9th: International Diabetes Federation, International diabetes federation. 2020
- BackgroundEltoony, 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.
- Results publication: PubMed 21494772O'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.
- Results publication: PubMed 27703397Farrar 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.
- Results publication: PubMed 9704245Metzger 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.
- Results publication: PubMed 32984182Khan 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.
- Results publication: PubMed 31402976Muche 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.
- Results publication: PubMed 27108148Hegazi 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.
- Results publication: PubMed 21860659Cavanaugh 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.
- Results publication: PubMed 30547769Lee 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.
- Results publication: PubMed 17416786Chu 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.
- Results publication: PubMed 19436673Cheung NW. The management of gestational diabetes. Vasc Health Risk Manag. 2009;5(1):153-64. doi: 10.2147/vhrm.s3405. Epub 2009 Apr 8.
- Individual participant dataSharing planned: Undecided. knowledge of women about different aspects of Gestational Diabetes Mellitus including general knowledge about the disease, risk factors, diet in diabetic patients and complications among the women in Sohag governorate ad the questionnaire itself
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel A Elsayed, Prof study chair
Professor doctor at department of Internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam E Mohamed Fawzy, Doctor (0109 386 0560, eslam.emad8275@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05148897, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.