- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07618286
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Üsküdar
-
Istanbul, Üsküdar, Tyrkiet (Türkiye), 34668
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Pregnant women over the age of 18,
- Between the 24th and 28th weeks of gestation,
- Who could speak and be literate in Turkish.
Exclusion Criteria:
- Pregnant women diagnosed with diabetes before pregnancy,
- Patients with speech and hearing impairments, and those not literate in Turkish.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Routine counseling
Participants received routine verbal counseling regarding gestational diabetes mellitus (GDM) screening, and the glucose challenge test (GCT) was recommended.
|
|
|
Eksperimentel: Structured training
Participants received a structured 15-20 minute audiovisual training program about gestational diabetes mellitus (GDM) screening.
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The effectiveness of structured audiovisual training
Tidsramme: 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.
|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Ayşe N Özaydın, Proff, MD, MPH, Marmara University
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Sygdomme i det endokrine system
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Metaboliske sygdomme
- Graviditetskomplikationer
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Opførsel
- Ernæringsmæssige og metaboliske sygdomme
- Behandlingsoverholdelse og compliance
- Sundhedsadfærd
- Patient Compliance
- Patientaccept af sundhedspleje
- Adhæsionsinterventioner
- Medicinadhærens
- Diabetes, svangerskabssyge
- Sundhedsuddannelse
Andre undersøgelses-id-numre
- 07.11.2018/141
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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