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Trial registered on ANZCTR


Registration number
ACTRN12614000854639
Ethics application status
Approved
Date submitted
19/07/2014
Date registered
8/08/2014
Date last updated
8/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Differences in the prevalence of Gestational Diabetes Mellitus and pregnant women's profile between the International Association of Diabetes in Pregnancy Study Groups and the National Diabetes Data Group diagnosis criteria
Scientific title
Gestational Diabetes Mellitus and International Association of Diabetes in Pregnancy Study Groups diagnosis criteria and National Diabetes Data Group diagnosis criteria and prevalence
Secondary ID [1] 285015 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 292529 0
Condition category
Condition code
Metabolic and Endocrine 292833 292833 0 0
Diabetes
Reproductive Health and Childbirth 292958 292958 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 223 pregnant women were included in the study group (SG), in which were diagnosed Gestational Diabetes Mellitus (GDM) considering the International of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria: First trimester fasting plasma glucose (FPG) greater than or equal to 92 mg/dl or in those with first trimester FPG less than 92 mg/dl a 75g oral glucose tolerance test (OGTT) performed between 24th and 28th week of gestation presenting one or more of these values: FPG greater than or equal to 92 mg/dl, after 1-hour greater than or equal to 180 mg/dl and/or after 2-hours greater than or equal to 153 mg/dl.
Intervention code [1] 289849 0
Diagnosis / Prognosis
Comparator / control treatment
As control group (CG) were included 444 pregnant women in which were followed the National Diabetes Data Group (NDDG) protocol for the diagnosis of Gestational Diabetes Mellitus (GDM): universal screening 50g oral glucose tolerance test (OGTT) performed between 24th and 28th weeks of pregnancy, or during the first trimester if there were risk factors for GDM (positive when 1h plasma glucose greater than or equal to 140 mg/dl) followed by a diagnostic 3-hours 100g-OGTT if two or more values were greater than or equal to the following: fasting plasma glucose (FPG) 105mg/dl; after 1-hour 190 mg/dl, after 2-hours 165 mg/dl and/or after 3-hours 145mg/dl.
Control group
Active

Outcomes
Primary outcome [1] 292700 0
The prevalence of Gestational Diabetes Mellitus (GDM) was assessed in the study group (SG) considering the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnostic criteria: First trimester fasting plasma glucose (FPG) greater than or equal to 92 mg/dl or in those with first trimester FPG less than 92 mg/dl a 75g oral glucose tolerance test (OGTT) performed between 24th and 28th week of gestation presenting one or more of these values: FPG greater than or equal to 92 mg/dl, after 1-hour greater than or equal to 180 mg/dl and/or after 2-hours greater than or equal to 153 mg/dl. As control group (CG) we included 444 pregnant women in which we followed the Natioanl Diabetes Data Groups (NDDG) protocol for the diagnosis of GDM: universal screening 50g-OGTT performed between 24th and 28th weeks of pregnancy, or during the first trimester if there were risk factors for GDM (positive when 1h plasma glucose greater than or equal to 140 mg/dl) followed by a diagnostic 3-hours 100g-OGTT if two or more values were greater than or equal to the following: FPG 105mg/dl; after 1-hour 190 mg/dl, after 2-hours 165 mg/dl and/or after 3-hours 145mg/dl.
In both groups, overt Diabetes Mellitus (DM) was assessed considering the FPM greater than or equal to 126 mg/dl.
Timepoint [1] 292700 0
In the study group (SG) Gestional Diabetes Mellitus (GDM) was assessed between 6-12 weeks' gestation for realized the first trimester fasting plasma glucose (FPG) and between 24-28 weeks' gestation for realized the 75g oral glucose tolerance test (OGTT). In the control group (CG) GDM was assessed between 24-28 weeks' gestation. In both groups, overt Diabetes Mellitus (DM) was assessed in each determination of FPG realized in gestation.
Secondary outcome [1] 309519 0
The profile of pregnant women was assessed studying the prevalence of risk factors for Gestational Diabetes Mellitus (GDM) according to the International Association of Diabetes in Pregnancy Study Groups (IADPSG) diagnosis criteria in the study group (SG) and the National Diabetes Data Group (NDDG) diagnosis criteria in the control group (CG). The risk factors studied in both groups were: maternal age as a quantitative and qualitative variable (age greater than or equal to 30 years old: yes / no), pre-gestational Body Mass Index (BMI) as a quantitative and qualitative variable (pre-gestational BMI greater than or equal to 30: yes / no), chronic hypertension (HTN) (considered greater than or equal to 140 / 90 mmhg), Diabetes Mellitus (DM) in first-degree relatives, personal history of GDM or Carbohydrates Intolerance (CHI), bad obstetric history: congenital malformations, macrosomia (birthweight greater than or equal to 4000g), caesarean section, perinatal mortality or pregnancy-related hypertension (gestational HTN greater than or equal to 140/90 mmhg).
Timepoint [1] 309519 0
The profile of pregnant women was assessed between 6-12 weeks' gestation.

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years old, a single-fetus pregnancy and signed consent to participate in the study, were included.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those women who did not meet the inclusion criteria, did not finish the diagnostic strategy for GDM and/or presented some carbohydrate disorder that had been diagnosed before the pregnancy were excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
According to the study "Evaluation of different diagnosis criteria for gestational diabetes" the prevalence of caesarean section is 17 to 39% in women with Gestational Diabetes Mellitus (GDM) and 16 to 26% for women with a negative screening for GDM. Assuming a prevalence of 39% in women with GDM compared with 26% in women with negative for GDM outcomes and assuming a confidence level of 95%, a potency of 90% and a 1:2 ratio groups, was obtained a minimum sample size of 202 pregnants for the study group (SG) and 404 pregnants for the control group (CG). Being the finally sample size study of 223 pregnants for the SC and 444 pregnants for the CG. The sample size was calculated using the program Epidat 3.1
Statistical analysis was made by the Statistical Package for Social Sciences version 15 (SPSS) software. Descriptive analysis has been done, noting the frequency of qualitative variables and the media +/- standard deviation (SD) for the quantitative variables. To study the normality, were used the Kolmogorov-Smirnov test. For univariate analysis, to evaluate the repercussion of those qualitative variables in both groups were used the Pearson's chi-squared test.
To compare media of quantitative variables between the groups, were used Student's t-test with independent samples and the Mann-Whitney as a non-parametric test. The dependent variables and its covariables have been analyzed by multiple linear regression, adjusting it by the group's variable. Were used a 95% Confidence of Intervals (CI). The significant value considered was P < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2013
Actual
11/02/2013
Date of last participant enrolment
Anticipated
2/05/2013
Actual
2/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
667
Accrual to date
Final
Recruitment outside Australia
Country [1] 6237 0
Spain
State/province [1] 6237 0
GALICIA

Funding & Sponsors
Funding source category [1] 289627 0
Hospital
Name [1] 289627 0
CENTRO MEDICO DE ESPECIALIDADES DE COIA
Country [1] 289627 0
Spain
Primary sponsor type
University
Name
UNIVERSIDAD DE VIGO
Address
CAMPUS UNIVERSITARIO C.P. 36.310 Vigo (Pontevedra)
Country
Spain
Secondary sponsor category [1] 288314 0
None
Name [1] 288314 0
Address [1] 288314 0
Country [1] 288314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291368 0
Clinical Research Ethics Committee of Galicia (CEIC)
Ethics committee address [1] 291368 0
Ethics committee country [1] 291368 0
Spain
Date submitted for ethics approval [1] 291368 0
05/11/2012
Approval date [1] 291368 0
04/02/2013
Ethics approval number [1] 291368 0
2012/214

Summary
Brief summary
BACKGROUND: The new diagnosis criteria proposed for the International Association of Diabetes and Pregnancy Study Groups (IADPSG) was based for the first time in adverse perinatal outcomes.
PURPOSE: To evaluate the prevalence of Gestational Diabetes Mellitus (GDM) with the new IADPSG diagnostic criteria and compare that the expected prevalence using the National Diabetes Data Group (NDDG) diagnostic criteria, and compared the prevalence of risk factors for GDM according to the used diagnostic criteria.
METHODS: Unicentric and randomized controlled trial, performed in Coia's Speciality Medical Center, Spain. The data collected initiated in February 2013 and the analysis was done in March 2014. A total of 223 pregnant women were included in the study group (SG) and as control group (CG) were included 444 pregnant women. Each group were reclassified into other dependents to the diagnostic criteria.
RESULTS: Total prevalence of GDM was 36.32% in SG and 11.26 % in CG. Comparing the risk factors studied in groups, was founded significant statistical differences for: DM in the first-degree relatives variable in SG and CG (p equal to 0.012), for the age as quantitative variable between SG-GDM and CG-GDM (p equal to 0.028) and between SG-OGTT and CG-GDM (p equal to 0.013), for the age greater than or equal to 30 years old qualitative variable between CG-GDM and SG-1T (p equal to 0.019) and between CG-N and CG-GDM (p equal to 0.015), for the pre-gestational BMI quantitative variable between CG-GDM and SG-1T (p equal to 0.017) and between CG-N and CG-GDM (p equal to 0.020) and for the pre-gestational BMI greater than or equal to 30 qualitative variable between SG-OGTT and SG-N (p equal to 0.026).
CONCLUSIONS: The prevalence of GDM increases using the IADPSG criteria and the pregnant women diagnosed with this new criteria had lower prevalence of risk factors for developing GDM who pregnant women diagnosed with the NDDG criteria.
Trial website
Trial related presentations / publications
Importancia de los factores de riesgo para la Diabetes Gestacional. Carmen Neri Fernández Pombo, María Reyes Luna Cano, Elena Allegue Magaz, Marta Lorenzo Carpente, Laura Beceito Dopico. Index Enferm 2016; 25(1-2): 18-21. ISSN: 1132 – 1296.
Public notes

Contacts
Principal investigator
Name 50062 0
Miss CARMEN NERI FERNANDEZ POMBO
Address 50062 0
Campus Universitario Lagoas de Marcosende. s/n. Vigo. 36200 Pontevedra. Galicia.
Country 50062 0
Spain
Phone 50062 0
+34610700586
Fax 50062 0
Email 50062 0
carmen.neri.fernandez.pombo@sergas.es
Contact person for public queries
Name 50063 0
Miss CARMEN NERI FERNANDEZ POMBO
Address 50063 0
Campus Universitario Lagoas de Marcosende. s/n. Vigo. 36200 Pontevedra. Galicia.
Country 50063 0
Spain
Phone 50063 0
+34610700586
Fax 50063 0
Email 50063 0
carmen.neri.fernandez.pombo@sergas.es
Contact person for scientific queries
Name 50064 0
Miss CARMEN NERI FERNANDEZ POMBO
Address 50064 0
Campus Universitario Lagoas de Marcosende. s/n. Vigo. 36200 Pontevedra. Galicia.
Country 50064 0
Spain
Phone 50064 0
+34610700586
Fax 50064 0
Email 50064 0
carmen.neri.fernandez.pombo@sergas.es

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