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AzTrials

Gestational Diabetes Mellitus (GDM)NCT07618286

The Effect of Structured Training on the Decision to Have a GDM Screening Test.

A study testing Structured training in people with Gestational Diabetes Mellitus (GDM), run by Nazan Tarhan at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes Mellitus (GDM)
What is being tested?
Structured training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2019to 31 Jul 2019
Phase
Interventional
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant women over the age of 18,
  • Between the 24th and 28th weeks of gestation,
  • Who could speak and be literate in Turkish.

Who cannot join

  • Pregnant women diagnosed with diabetes before pregnancy,
  • Patients with speech and hearing impairments, and those not literate in Turkish.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    Istanbul, Üsküdar, 34668

Other trials in Turkey (Türkiye)

About this study

Official title: How Effective the Structured Training in the Decision of Screening of Gestational Diabetes? Randomised Controlled Trial

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.

Read the detailed description

This is a randomised controlled intervention study. This was conducted at Zeynep Kamil Women's and Children's Diseases Training and Research Hospital, in İstanbul, Türkiye, between January-July 2019. Ethical permission was obtained from the Hospital's Ethics Committee (Approval date/number: 07.11.2018/141). The formal study permission was obtained from the İstanbul Province Health Directorate because the hospital was an governmental hospital. All eligible participants were informed and they were invited to the study and the accepted participants signed their consents.

Antenatal follow-up in Türkiye is conducted in accordance with the Ministry of Health's Prenatal Care Management Guide. This guidance recommends 50 g glucose challenge test (GCT) between 24-28 weeks for pregnant women who are not at high risk.

The target group of the study consisted of pregnant women who applied to the outpatient clinics of the hospital in İstanbul. Pregnant women over the age of 18, between the 24-28th weeks of pregnancy, who could speak Turkish, were literate were included in the study. Pregnant women diagnosed with diabetes before pregnancy, in the first trimester or third trimester, with speech and hearing impairments, and those who were not literate in Turkish were excluded from the study.

The sample size was calculated with the Open-Epi program. Hospital electronic data for 2017 was reviewed and it was determined that only 40% of pregnant women who were recommended 50 g GCT had the test. The sample calculation was made with the expectation that this rate would increase to 60% with the training planned in the study. The number of pregnant women to be included in the study was calculated as 98 for each group, 196 in total. The probability of lost to follow-up was calculated as 40% and the sample size was increased to 280(140+140).

Patient recruitment was conducted between May and June 2019. Two hundred and five volunteer pregnant women who met the inclusion criteria, had not yet been diagnosed with diabetes mellitus according to national and international guidelines, and were recommended for GCT were invited to participate in the study. They were randomly assigned to two groups: control (n=101) and intervention (n=104). Participants were randomly assigned to either the intervention group or the control group in a 1:1 using a simple coin toss method. Outpatient examination time was 15 minutes. Pregnant women were given standard information about GCT during this time. The GCT was recommended verbally, directly to control group. Pregnant women assigned to the intervention group were invited to trainings.

The trainings were held in a room arranged for this purpose in the hospital, with one participant, by the same researcher (first author), lasted about 15 minutes and were applied in mutual communication with the questions of the participants. The materials which used were an Audio-Visual Aid/Pictured Guide Book prepared for this study and named as Gestational Diabetes Pregnant Education Guide, a transparent package containing 50 g glucose powder and a commercially packaged 50 g glucose drink package.

The training guide book was prepared by 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 GDPEG was prepared in a power point 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 GDPEG was placed in a presentation folder that enabled face-to-face training.

Researchers prepared transparent packets containing an amount of glucose corresponding to the amount of glucose in the solution used in diabetes screening tests. Participants were also shown commercially prepared packets containing the same amount of glucose. The purpose of visually sharing the packets was to inform the pregnant about the amount of glucose used in the test and to allow them to compare it to their daily consumption.

The same experienced obstetrician and gynecologist on the study team provided verbal information regarding the test given to the control group.

Data collected at the first admission to the hospital by face to face from all pregnant women eligible and accepted to the invitation of this study. All pregnant women who agreed to participate in the study were asked to complete a data collection tool. The results of whether they had GCT or not were obtained from hospital registration system.

The test results were confirmed from electronic records within 2-16 weeks after the examination. The results of the pregnant women who had the test done in our hospital were obtained from the hospital registry system. Pregnant women whose test results could not be seen in the hospital registry system, were contacted by phone to find out whether they had the test done at another center. The test results were requested as a document from the pregnant women who had the test.

Being tested
Structured training
Keywords
gestational diabetes mellitus, glucose challenge test, health education
Medical subject headings
Diabetes, Gestational, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured trainingOther

    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.

Study groups in NCT07618286
Study groupRoleWhat they receive
Routine counselingNo interventionParticipants received routine verbal counseling regarding gestational diabetes mellitus (GDM) screening, and the glucose challenge test (GCT) was recommended.
Structured trainingExperimentalParticipants received a structured 15-20 minute audiovisual training program about gestational diabetes mellitus (GDM) screening.
Receives: Other: Structured training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start1 Jan 2019
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618286
Sponsor's protocol ID
07.11.2018/141
Status last verified
May 2026
First submitted
16 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 480298
  • Li 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.

    PubMed 32405502
  • Freinkel 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.

    PubMed 3888733

Questions about this trial

What is this clinical trial studying?

A study testing Structured training in people with Gestational Diabetes Mellitus (GDM), run by Nazan Tarhan at 1 site in Turkey (Türkiye).

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jun 2026. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effectiveness of structured audiovisual training (time frame: 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.). 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 NCT07618286, which also lists 3 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 1 Jun 2026.

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