The Effect of Structured Training on the Decision to Have a GDM Screening Test.
How Effective the Structured Training in the Decision of Screening of Gestational Diabetes? Randomised Controlled Trial
1 other identifier
interventional
199
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of training pregnant women on the decision of having an oral glucose challenge test (GCT), which is recommended by a physician for screening of gestational diabetes mellitus (GDM). Primary hypothesis is that structured training is effective in increasing pregnant women's acceptance of gestational diabetes mellitus (GDM) screening. The effect of training on patients' decision-making regarding gestational diabetes mellitus (GDM) screening was planned to be evaluated. Participants in the control group received standard counseling about GDM screening. Participants in the intervention group received a structured, specific audiovisual educational program supported by a guidebook, lasting approximately 15-20 minutes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedJune 1, 2026
May 1, 2026
7 months
May 16, 2026
May 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effectiveness of structured audiovisual training
Information on whether participants had undergone the glucose challenge test (GCT) or had not undergone the GCT was obtained from medical records. Having undergone the GCT was coded as 1, and not having undergone the GCT was coded as 0. The effectiveness of the intervention was then evaluated by calculating the relative effectiveness increase, attributed effectiveness, and efficacy (protection) rate.
Information on whether participants had undergone the glucose challenge test (GCT) or had not undergone the GCT was obtained from medical records within 2-16 weeks after the first examination.
Study Arms (2)
Routine counseling
NO INTERVENTIONParticipants received routine verbal counseling regarding gestational diabetes mellitus (GDM) screening, and the glucose challenge test (GCT) was recommended.
Structured training
EXPERIMENTALParticipants received a structured 15-20 minute audiovisual training program about gestational diabetes mellitus (GDM) screening.
Interventions
The trainings lasted about 15 minutes and were applied in mutual communication with the questions of the participants. The materials that were used were an audiovisual aid/pictured guidebook prepared for this study and named the Gestational Diabetes Pregnant Education Guide and a transparent package containing 50 g glucose powder and a commercially packaged 50 g glucose drink package. The training guidebook was prepared by the authors. The educational materials were prepared by two obstetrics and gynecology specialists and one public health expert with over 15 years of experience in their fields. The guidebook was prepared in a PowerPoint program and consisted of 14 sheets and 28 pages. The odd-numbered pages were arranged to be seen and understood by the patient. The even-numbered pages contained the information to be explained by the educator. The guidebook was placed in a presentation folder that enabled face-to-face training.
Eligibility Criteria
You may qualify if:
- Pregnant women over the age of 18,
- Between the 24th and 28th weeks of gestation,
- Who could speak and be literate in Turkish.
You may not qualify if:
- Pregnant women diagnosed with diabetes before pregnancy,
- Patients with speech and hearing impairments, and those not literate in Turkish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nazan Tarhanlead
- Marmara Universitycollaborator
Study Sites (1)
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, Üsküdar, 34668, Turkey (Türkiye)
Related Publications (3)
Stewart MA, McWhinney IR, Buck CW. The doctor/patient relationship and its effect upon outcome. J R Coll Gen Pract. 1979 Feb;29(199):77-81.
PMID: 480298BACKGROUNDLi Z, Cheng Y, Wang D, Chen H, Chen H, Ming WK, Wang Z. Incidence Rate of Type 2 Diabetes Mellitus after Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis of 170,139 Women. J Diabetes Res. 2020 Apr 27;2020:3076463. doi: 10.1155/2020/3076463. eCollection 2020.
PMID: 32405502BACKGROUNDFreinkel N, Metzger BE, Phelps RL, Dooley SL, Ogata ES, Radvany RM, Belton A. Gestational diabetes mellitus. Heterogeneity of maternal age, weight, insulin secretion, HLA antigens, and islet cell antibodies and the impact of maternal metabolism on pancreatic B-cell and somatic development in the offspring. Diabetes. 1985 Jun;34 Suppl 2:1-7. doi: 10.2337/diab.34.2.s1.
PMID: 3888733BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayşe N Özaydın, Proff, MD, MPH
Marmara University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- OB-GYN, MPH, MD
Study Record Dates
First Submitted
May 16, 2026
First Posted
June 1, 2026
Study Start
January 1, 2019
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
During the ethics committee approval process for the study, it was declared that personal data would only be shared with members of the ethics committee and the study team. Upon request, individual participant data (IPD) can be shared following approval from the ethics committee and in accordance with its authorization.