NCT05148897

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

November 10, 2021

Last Update Submit

December 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Questionnaire

Interventions

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.

All Women can participate

Eligibility Criteria

Age13 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemalesare the direct face of gestational diabetes, and they are the most vulnerable to the disease and need to be aware of it
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cross sectional descriptive using questionnaire method in Sohag governorate among 500Women, over 6 months by random selection

You may qualify if:

  • All Females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (13)

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Adel A Elsayed, Prof

    Professor doctor at department of Internal medicine

    STUDY CHAIR

Central Study Contacts

Eslam E Mohamed Fawzy, Doctor

CONTACT

Hamdy s Mohamed, Ass.Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at department of internal medicine

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 8, 2021

Study Start

October 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations