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Comparison of different criteria for diagnosis of gestational diabetes mellitus

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Introduction: The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria for gestational diabetes mellitus (GDM) has been adopted by most associations across the world including the American Diabetes Association and World Health Organization (WHO). We conducted a study comparing the IADPSG and previous WHO criteria and their effects on neonatal birth weight. Methods: The study was carried out in Obstetrics and Gynaecology Department of a tertiary care institute in South India in collaboration with Endocrinology Department. Thousand two hundred and thirty‑one antenatal cases with at least one risk factor for GDM and gestational age of more than 24 weeks were included in the study. Both criteria were compared on the basis of 75 g oral glucose tolerance test results. Results: The prevalence of GDM using IADPSG and previous WHO criteria were 12.6% and 12.4%, respectively. The prevalence of GDM was 9.9% when both criteria had to be satisfied. Both GDM criteria groups did not differ in neonatal birth weight and macrosomia rate. However, there was a significant increase in lower segment cesarean section in IADPSG criteria group. Elevated fasting plasma glucose alone picked up only one GDM in the previous WHO criteria group. Conclusions: A single 2 h plasma glucose is both easy to perform and economical. A revised WHO criterion using a 2 h threshold of ≥140 mg % can be adopted as a one‑step screening and diagnostic procedure for GDM in our country. Key words: Gestational diabetes mellitus, International Association of Diabetes in Pregnancy Study Group, macrosomia, outcomes, World Health Organization
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© 2015 Indian Journal of Endocrinology and Metabolism | Published by Wolters Kluwer - Medknow
824
introduction
Diabetes is one of the most common medical complications
of pregnancy. It complicates two to five percent of
pregnancies, of which 90% is contributed by gestational
diabetes mellitus (GDM).[1] GDM has been dened as
any degree of glucose intolerance with onset or rst
Comparison of different criteria for diagnosis of
gestational diabetes mellitus
Haritha Sagili, Sadishkumar Kamalanathan1, Jayaprakash Sahoo1, Subitha Lakshminarayanan2, Reddi Rani,
D. Jayalakshmi, K. T. Hari Chandra Kumar3
Departments of Obstetrics and Gynecology, 1Endocrinology and Metabolism, 2PSM and 3Biostatistics Jawaharlal Institute of Postgraduate
Medical Education and Research, Puducherry, India
ABSTRACT
Introduction: The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria for gestational diabetes
mellitus (GDM) has been adopted by most associations across the world including the American Diabetes Association and World
Health Organization (WHO). We conducted a study comparing the IADPSG and previous WHO criteria and their effects on neonatal
birth weight. Methods: The study was carried out in Obstetrics and Gynaecology Department of a tertiary care institute in South India
in collaboration with Endocrinology Department. Thousand two hundred and thirty‑one antenatal cases with at least one risk factor for
GDM and gestational age of more than 24 weeks were included in the study. Both criteria were compared on the basis of 75 g oral
glucose tolerance test results. Results: The prevalence of GDM using IADPSG and previous WHO criteria were 12.6% and 12.4%,
respectively. The prevalence of GDM was 9.9% when both criteria had to be satised. Both GDM criteria groups did not differ in neonatal
birth weight and macrosomia rate. However, there was a signicant increase in lower segment cesarean section in IADPSG criteria
group. Elevated fasting plasma glucose alone picked up only one GDM in the previous WHO criteria group. Conclusions: A single
2 h plasma glucose is both easy to perform and economical. A revised WHO criterion using a 2 h threshold of ≥140 mg % can be
adopted as a one‑step screening and diagnostic procedure for GDM in our country.
Key words: Gestational diabetes mellitus, International Association of Diabetes in Pregnancy Study Group, macrosomia, outcomes,
World Health Organization
Corresponding Author: Dr. Sadishkumar Kamalanathan,
Department of Endocrinology, Jawaharlal Institute of Postgraduate
Medical Education and Research, Puducherry ‑ 605 005, India.
E‑mail: sadishkumar.k@jipmer.edu.in
recognition during pregnancy and does not exclude the
possibility that unrecognized glucose intolerance may
have antedated or begun concomitantly with pregnancy.[1]
It is important to screen for GDM in pregnancy because
glucose intolerance is associated with adverse maternal
and fetal outcomes and women with history of GDM, and
their children are at risk of developing diabetes in future.[2,3]
The hyperglycemia and adverse pregnancy outcomes study
involving 25,505 pregnant women showed that the risk of
adverse maternal, fetal, and neonatal outcome increased
even within ranges previously considered normal for
pregnancy.[4]
Cite this article as: Sagili H, Kamalanathan S, Sahoo J, Lakshminarayanan S,
Rani R, Jayalakshmi D, et al. Comparison of different criteria for diagnosis of
gestational diabetes mellitus. Indian J Endocr Metab 2015;19:824-8.
This is an open access article distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 3.0 License, which allows
others to remix, tweak, and build upon the work non‑commercially, as long as the
author is credited and the new creations are licensed under the identical terms.
For reprints contact: reprints@medknow.com
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DOI:
10.4103/2230-8210.167550
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Sagili, et al.: Diagnostic criteria for gestational diabetes mellitus
Indian Journal of Endocrinology and Metabolism / Nov-Dec 2015 / Vol 19 | Issue 6 825
Asian women have a vefold increase in risk of developing
GDM compared to Caucasian women.[5] Among the ethnic
groups in South Asia, Indian women have the highest
incidence of GDM.[6] In India, a community‑based study
involving 12,056 pregnant women found the prevalence of
GDM to be 13.9%.[7] Hence, screening for GDM during
pregnancy, especially in high‑risk cases has become necessary.
Currently, there is no standard single test for diagnosing
GDM. Different criteria proposed for the screening of
GDM includes American Diabetes Association (ADA)
and previous World Health Organization (WHO) criteria.
Recently, both ADA and WHO adopted the criteria
proposed by International Association of Diabetes in
Pregnancy Study Group (IADPSG).[8‑10] Our study aimed
to compare IADPSG and previous WHO criteria for
diagnosing GDM and to examine its effects on neonatal
birth weight.
mEthods
This prospective clinical study was carried out in the
Department of Obstetrics and Gynaecology in
coordination with Department of Endocrinology of a
tertiary care medical institute in South India after obtaining
ethical committee approval. Antenatal cases of gestational
age ≥24 weeks attending outpatient department with
any one of the following risk factors for GDM were
included in the study: Obesity, chronic hypertension,
bad obstetric history e.g. past history of preeclampsia,
gestational diabetes, premature delivery, unexplained
neonatal death, intrauterine death, stillbirth, delivery
of a large infant (≥3.5 kg), recurrent pregnancy loss
(≥3 spontaneous abortions in rst or second trimester),
and family history of diabetes. Known cases of Type I or
Type II diabetes mellitus were excluded from the study.
All women satisfying the inclusion criteria were subjected
to clinical examination after getting a detailed history and
informed consent. Weight and height were obtained from
antenatal records. Body mass index (BMI) was calculated
by dividing the pre‑pregnancy weight in kilograms by the
square of height in meters. Venous blood samples were
collected from them in fasting, 1 h and 2 h following 75 g
of oral glucose load. The plasma glucose was estimated by
glucose oxidation and peroxidation method.
All participants were diagnosed as GDM using
IADPSG criteria (anyone abnormal value in oral glucose
tolerance test (OGTT): Fasting plasma glucose (FPG)
≥5.11 mmol/l, 1 h plasma glucose ≥10 mmol/l and 2 h
plasma glucose ≥8.5 mmol/l) and WHO criteria (anyone
abnormal value in OGTT: FPG ≥7 mmol/l, and 2 h
plasma glucose ≥7.78 mmol/l). They were stratied into
the following groups: Normal glucose tolerance (NGT) by
both IADPSG and WHO, GDM by IADPSG only, GDM
by WHO only, and GDM by both IADPSG and WHO
criteria [Figure 1]. Antenatal women diagnosed to have
GDM by either IADPSG or WHO criteria were managed
initially with medical nutrition therapy and daily moderate
exercise for 30 min or more.[11] They were followed up with
self‑monitoring of blood glucose (after an overnight fast,
2 h after breakfast, 2 h after lunch, and 2 h after dinner)
at home. Those having FPG >5.28 mmol/l and/or 2 h
postprandial plasma glucose >7.8 mmol/l (more than 30%
of glucose measurements above the recommended value)
despite lifestyle modication for 2 weeks were treated
either with metformin (1000–1500 mg daily) or insulin
according to patient’s choice. Those with FPG >6.1 mmol/l
in OGTT were given human regular and NPH insulin
subcutaneous injections directly. The patients were followed
up to delivery. The preterm delivery, if any and the mode
of delivery (lower segment cesarean section [LSCS] vs.
instrumental vs. vaginal) were noted. After delivery, the
birth weight and APGAR scores (1 and 5 min) were
recorded for all newborns. Macrosomia was dened as the
birth weight ≥3.5 kg in our study.[12]
The data collected were analyzed using the SPSS software
version 17. Descriptive statistics was used for demographic
variables and categorical data were compared using χ2
test. The level of agreement in GDM diagnosed between
the criteria was assessed by pairwise comparisons using
kappa statistics (k). All statistical analysis was carried out
at 5% level of signicance, and P < 0.05 was considered
as signicant.
rEsults
In our study, 1231 cases with at least one risk factor for GDM
were studied. Among them, 155 cases (12.6%) were diagnosed
as GDM by IADPSG criteria and 153 cases (12.4%) by
WHO only (31) Both (122) IADPSG only (33)
Figure 1: Detection rate of gestational diabetes mellitus by different criteria
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Sagili, et al.: Diagnostic criteria for gestational diabetes mellitus
Indian Journal of Endocrinology and Metabolism / Nov-Dec 2015 / Vol 19 | Issue 6
826
previous WHO criteria. Both criteria picked up 122 (9.9%)
GDM subjects [Figure 1]. There was a good level of
agreement between the two diagnostic criteria, and κ = 0.754
(P < 0.001). In WHO group, all patients except one were
picked up by 2 h plasma glucose value alone [Table 1].
However, 70% of those diagnosed by IADPSG criteria alone
had isolated elevated FPG. Most of the women (82–83%)
diagnosed with GDM by either IADPSG or WHO criteria
were managed with diet alone. Both the groups had a
good control of blood glucose. Twenty‑ve subjects in the
WHO group and 27 cases in the IADPSG group required
metformin along with diet. Three patients on metformin
had nausea and mild gastric intolerance which resolved with
dose reduction. Five cases diagnosed as GDM by WHO
criteria and 7 cases diagnosed by IADPSG required insulin.
Two patients in WHO and 3 in IADPSG group opted for
insulin from beginning. In addition, 2 patients in WHO and
3 in IADPSG group were initiated on insulin directly as their
FPG in OGTT was >6.1 mmol/l. Rest one patient in each
group was given added insulin following suboptimal glycemic
control with metformin.
The GDM subjects diagnosed by either IADPSG or WHO
criteria were signicantly older with greater weight and BMI
compared to their non‑GDM counterparts [Table 2]. Most
of those diagnosed as GDM had a vaginal delivery. The
GDM subjects diagnosed by IADPSG criteria had a higher
rate of LSCS as compared to NGT group (15.5% vs. 9.2%,
P = 0.01). In contrast, those diagnosed by WHO criteria
had similar LSCS rate.
The babies born to GDM mothers diagnosed by either
criteria had increased birth weight and macrosomia
rate as compared to non‑GDM mothers [Table 2]. In
total, 14.9% and 17.1% of those diagnosed as GDM
by IADPSG and WHO, respectively, had babies with
birth weight ≥3.5 kg (macrosomia) as compared to 5%
among non‑GDM mothers. Of 79 babies with birth
weight ≥3.5 kg in this study, 27 (34%) babies were born
to mothers identied as having GDM. All but one (26/27)
macrosomic babies were identied by WHO criteria versus
only 85% (23/27) by IADPSG criteria). There was a
stillbirth in WHO group and one intrauterine death in
IADPSG group in the study.
discussion
The detection rate of GDM by either IADPSG or
previous WHO criteria was similar (12.4% vs. 12.6%) with
around 75% of agreement in our study. The prevalence
of GDM varied from 6.6% to 24.3% in various studies
from South‑East Asia.[13‑16] The pickup rate of GDM by
both criteria has been different across various studies.
It was higher by WHO criteria (24.3% vs. 20.4%) in a
study involving 2772 pregnant women done at a referral
maternity center in Vietnam.[13] However, IADPSG criteria
detected more GDM cases in the studies by Gilder et al.[14]
from Thailand (6.6% vs. 10.1%) and Dahanayaka et al.[15]
from Srilanka (7.2% vs. 8.9%). These disparities in GDM
burden can be explained by the varying ethnicity of study
population, the type of screening (universal vs. risk‑based)
used and the setting (community vs. tertiary care hospital)
Table1:ComparisonbetweenIADPSGandprevious
WHO criteria
Parameters GDM
(IADPSG
only)
N=33 (%)
GDM
(WHO
only)
N=31 (%)
GDM
(IADPSG±
WHO)
N=155 (%)
GDM
(WHO±
IADPSG)
N=153 (%)
Only FPG elevated 23 (70) 00 31 (20) 1 (<1)
Only 1 h PG elevated 08 (24) NA 36 (22.6) NA
Only 2 h PG elevated 00 31 (100) 23 (14.8) 145 (95)
Any 2 values elevated 02 (6) 00 30 (20) 07 (4.6)
All 3 values elevated 00 NA 35 (22.6) NA
FPG: Fasting plasma glucose, PG: Plasma glucose, GDM : Gestational diabetes mellitus,
IADPSG: International Association of Diabetes in Pregnancy Study Group, WHO: World
Health Organization
Table2:ComparisonbetweenGDMandnon‑GDMgroup
Parameters GDM(IADPSG±
WHO) N=155
GDM(WHO±
IADPSG)N=153
NGT
N=1045
P*
(A vs. C)
P*
(B vs. C)
Age (years) 27.19±4.65 26.92±4.85 24.98±4.02 0.0001 0.0001
Primigravida (%) 60 (38.7) 63 (41.2) 431 (41.4) 0.52 0.96
Height (m) 1.53±0.07 1.53±0.07 1.53±0.06 0.26 0.67
Weight (kg) 63.21±12.34 62.73±13.07 59.58±12.17 0.001 0.003
BMI (kg/m2) 26.87±5.32 26.75±5.41 25.49±5.12 0.002 0.005
Instrumental delivery (%) 09 (5.8) 08 (5.2) 70 (6.7) 0.80 0.60
LSCS (%) 24 (15.5) 18 (11. 8) 96 (9.2) 0.01 0.31
Preterm (%) 03 (1.9) 05 (3.3) 18 (1.7) 0.74 0.20
Birth weight (kg) 2.97±0.44 3±0.47 2.86±0.34 0.003 0.001
BW >3.5 kg (%) 23 (14.9) 2 6 (17.1) 52 (5) 0.0001 0.0001
APGAR‑1 7.94±0.52 7.94±0.52 7.98±0.25 0.28 0.28
APGAR‑5 8.94±0.47 8.95±0.47 8.99±0.20 0.28 0.27
BMI: Body mass index, LSCS: Lower segment cesarean section, BW: Birth weight, *A: GDM (IADPSG ± WHO) group, B: GDM (WHO ± IADPSG) group, C: NGT group,
GDM: Gestational diabetes mellitus, IADPSG: International Association of Diabetes in Pregnancy Study Group, NGT: Normal glucose tolerance, WHO: World Health Organization
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Sagili, et al.: Diagnostic criteria for gestational diabetes mellitus
Indian Journal of Endocrinology and Metabolism / Nov-Dec 2015 / Vol 19 | Issue 6 827
in which the study was conducted. Universal screening
picked up more GDM cases compared to a risk‑based
approach.[15,17] The risk factor based approach missed up
to one‑third of GDM cases by IADPSG criteria in the
study from Srilanka.[15]
The primary differences between these two GDM
diagnostic criteria are lower FPG and 2 h in IADPSG and
WHO criteria, respectively.[8,9] This fact was reafrmed in
our study. All but one GDM mother were picked up by 2 h
PG in WHO criteria in contrast to the majority of them
identied by FPG in IADPSG criteria [Table 1]. Similar
ndings were also reported in other studies.[15,18] Thirty‑one
GDM subjects were diagnosed by WHO criteria alone in
contrast to 33 cases in IADPSG group alone in this study
[Table 1]. In other words, 16.7% and 17.7% were missed
by either criteria alone. This gure varies from 16.3% to
32.6% in the literature.[15,18]
The GDM subjects in either group were older with higher
weight/BMI compared to their non‑GDM counterparts.
These ndings are uniform across various studies.[7,13] A study
from Vietnam found that age and BMI at antenatal booking
were the strongest predictors of development of GDM.[13]
Similarly, both age ≥25 years and BMI ≥25 kg/m2 had a
signicant independent association with GDM in a study
by Seshiah et al.[7] In a recent meta‑analysis of twenty
studies, the unadjusted odds ratios of developing GDM
were 2.14 (95% condence interval [CI], 1.82–2.53), 3.56
(3.05–4.21), and 8.56 (5.07–16.04) among overweight,
obese, and severely obese compared with normal‑weight
pregnant women, respectively.[19]
GDM women diagnosed by either criteria are at
higher risk for both LSCS and large for gestational
age (LGA), but macrosomia is associated with only
GDM mothers diagnosed by WHO criteria in two
meta‑analyses.[20,21] Additionally, these associations are more
consistent in WHO group. The treatment of GDM reduces
both macrosomia (relative risk [RR] = 0.47; 95% CI,
0.34–0.65) and LGA birth (RR = 0.57; 95% CI, 0.47–0.71)
in the meta‑analysis by Falavigna et al.[22] Compared to
WHO criteria, IADPSG criteria reduced the incidence of
LGA by 0.32% (0.09–0.63%) in addition.[23] However, there
was no statistically signicant reduction in the cesarean
section with treatment for GDM in either group.[22] That
means treatment of gestational diabetes may not able to
prevent all adverse outcomes associated with GDM. Similar
ndings were found in our study too. GDM subjects
diagnosed by either criteria had increased birth weight
and macrosomic babies compared to non‑GDM mothers.
However, the prevalence of LSCS rate was more frequent
only in IADPSG group.
The strength of our study was its large sample size with
uniform protocol for screening and treatment of all GDM
cases at a single antenatal care center. There are also few
limitations in this study. As this was a hospital‑based study
in a semi‑urban setting, the results may not be applicable to
the general population. Second, all the parameters related
to feto‑maternal outcomes were not evaluated.
To conclude, the diagnostic pick‑up rate of GDM was
similar with both IADPSG and previous WHO criteria in
our hospital‑based study. The neonatal birth weight and
macrosomia rate among GDM women diagnosed with
either criteria were comparable. Being easy to perform
and economical, a revised WHO criterion of a 2 h PG
threshold level of ≥140 mg % may logistically serve as a
one‑step screening and diagnostic procedure for GDM.
Financial support and sponsorship
Nil.
Conicts of interest
There are no conicts of interest.
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Article
Full-text available
Background and Objectives: Gestational diabetes mellitus (GDM) is a global health concern as it affects health status of both mother and fetus. In India, prevalence of GDM varies in different populations and no data is available from rural Haryana. This study was undertaken to determine the prevalence of GDM and risk factors associated with it in rural women of Haryana. Materials and Methods: Nine hundred and thirteen women, with estimated gestational age above 24 weeks from a rural block of Haryana who consented to participate were given a standardized 2-h 75-g oral glucose tolerance test (OGTT). Pro forma containing general information on demographic characteristics, educational level, gravida, family history of diabetes, and past history of GDM was filled-up. A World Health Organization (WHO) criterion for 2-h 75-g OGTT was used for diagnosing GDM. Results: GDM was diagnosed in 127/913 (13.9%) women with higher mean age as compared to non-GDM women. Majority (78.4%) of the women were housewives, rest engaged in agriculture (9.2%) and labor (5.5%). Women with gravida ≥3 and positive family history of diabetes had significantly higher prevalence of GDM. History of macrosomia (birth weight ≥4 kg) was significantly associated with prevalence of GDM (P = 0.002). On multiple logistic regression analysis, risk factors found to be significantly associated with GDM were maternal age >25 years, gravida >3, history of macrosomic baby, and family history of diabetes. Conclusion: The prevalence of GDM has been found quite high in rural Haryana. Appropriate interventions are required for control and risk factor modifications.
Article
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Background Individuals in conflict-affected areas rarely get appropriate care for chronic or non-infectious diseases. The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide, and new evidence shows conclusively that the negative effects of hyperglycemia occur even at mild glucose elevations and that these negative effects can be attenuated by treatment. Scientific literature on gestational diabetes in refugee camp settings is critically limited. Methods A 75 g 2-hour glucose tolerance test was administered to 228 women attending the antenatal care (ANC) clinic in Maela refugee camp on the Thai–Myanmar border. Prevalence of GDM was determined using the HAPO trial cut-offs [≥92 mg/dL (fasting),≥180 (1 hour), and≥153 (2 hour)] and the WHO criteria [≥126 mg/dL (fasting), and 140 mg/dL (2 hour)]. Results From July 2011 to March 2012, the prevalence of GDM was 10.1% [95% confidence interval (CI): 6.2–14.0] when the cut-off determined by the HAPO trial was applied. Applying the older WHO criteria yielded a prevalence of 6.6% (95% CI 3.3–9.8). Age, parity, and BMI emerged as characteristics that may be significantly associated with GDM in this population. Other risk factors that are commonly used in screening guidelines were not applicable in this diabetes-naïve population. Discussion The prevalence of GDM is lower in this population compared with other populations, but still complicates 10% of pregnancies. New evidence regarding gestational diabetes raises new dilemmas for healthcare providers in resource-poor settings. Efforts to identify and treat patients at risk for adverse outcomes need to be balanced with awareness of the risks and burdens associated with over diagnosis and unnecessary interventions. Screening approaches based on risk factors or using higher cut-off values may help minimize this burden and identify those most likely to benefit from intervention.
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Objective: Our objective was to formulate a clinical practice guideline for the management of the pregnant woman with diabetes. Participants: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, 5 additional experts, a methodologist, and a medical writer. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. Consensus process: One group meeting, several conference calls, and innumerable e-mail communications enabled consensus for all recommendations save one with a majority decision being employed for this single exception. Conclusions: Using an evidence-based approach, this Diabetes and Pregnancy Clinical Practice Guideline addresses important clinical issues in the contemporary management of women with type 1 or type 2 diabetes preconceptionally, during pregnancy, and in the postpartum setting and in the diagnosis and management of women with gestational diabetes during and after pregnancy.
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We aimed to compare the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and the World Health Organization (WHO) criteria to diagnose gestational diabetes mellitus (GDM) in Chennai, India. We reviewed the retrospective data of 1351 pregnant women who underwent screening for GDM at four selected diabetes centers at Chennai (three private and one government). All women underwent an oral glucose tolerance test using 75g glucose load and fasting, 1-h, and 2-h samples were collected. The IADPSG and WHO criteria were compared for diagnosis of GDM. A total of 839 women had GDM by either the IADPSG or the WHO criteria, of whom the IADPSG criteria identified 699 and the WHO criteria also identified 699 women as having GDM. However, only 599/839 women (66.6%) were identified by both criteria. Thus, 140/839 women (16.7%) were missed by both the IADPSG and the WHO criteria. 687/699 (98.2%) of the women with GDM were identified by the WHO criteria. In contrast, each value of IADPSG criteria i.e., fasting, 1 h, and 2 h identified only 12.5%, 14%, and 22%, respectively. A single WHO cut-point of 2 h > 140 mg/dl appears to be suitable for large-scale screening for GDM in India and other developing countries.
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