NCT07618286

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

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 16, 2026

Last Update Submit

May 25, 2026

Conditions

Keywords

gestational diabetes mellitusglucose challenge testhealth education

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 INTERVENTION

Participants received routine verbal counseling regarding gestational diabetes mellitus (GDM) screening, and the glucose challenge test (GCT) was recommended.

Structured training

EXPERIMENTAL

Participants received a structured 15-20 minute audiovisual training program about gestational diabetes mellitus (GDM) screening.

Other: Structured training

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.

Structured training

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

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: 480298BACKGROUND
  • 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.

    PMID: 32405502BACKGROUND
  • 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.

    PMID: 3888733BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes, GestationalHealth Education

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ayşe N Özaydın, Proff, MD, MPH

    Marmara University

    STUDY DIRECTOR

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.

Locations