Table 3.
One-Step Screening with IADPSG Criteria versus One- or Two-Step Screening with Other Criteria
| Author, Year/Country (Ref.) | Design | Subjects (N) | Study Population | Comparison | Main Results |
|---|---|---|---|---|---|
| Observational Studies | |||||
| Agarwal, 2010/UAE45 | Retrospective cohort study | 10,283 | All pregnant women | Impact of IADPSG criteria on GDM diagnosis compared to ADA criteria | The IADPSG criteria caused a 2.9-fold increase in GDM prevalence (37.7% of all pregnant women with IADPSG criteria vs 12.9% with ADA criteria) |
| Rajput, 2012/ India49 | Prospective study | 607 | Pregnant women without ODIP | HbA1c in combination with ADA vs IADPSG criteria for diagnosis of GDM | 7.1% were diagnosed as having GDM based on ADA criteria while 23.72% women were diagnosed as having GDM using IADPSG criteria |
| Benhalima, 2013/Belgium59 | Retrospective cohort study | 6727 | Singleton pregnancies without ODIP and bariatric surgery | CC criteria (old GDM) vs IADPSG criteria (new GDM) for GDM screening | More women were identified as having GDM using the IADPSG criteria and these women carried an increased risk for adverse gestational outcome compared to women without GDM |
| Duran, 2014/ Spain56 | Prospective cohort study | 3276 | Pregnant women without ODIP | One-step IADPSG vs two-step ADA recommended GDM screening | Application of IADPSG screening was associated with a 3.5-fold increase in GDM prevalence as well as significant improvements in pregnancy outcomes |
| Fuller, 2014/US50 | Pre–post comparison study | 812 | Pregnant women without ODIP and gastric bypass | One-step (2h 75g OGTT, IADPSG criteria) vs two-step (50g GCT followed by 3h 100g OGTT and CC criteria if GCT ≥7.5 mmol/L) | Despite a 4.7% increase in GDM (from 7% to 11.7%), no differences in delivery or neonatal outcomes and no lower rates of compliance with screening were found when using one-step vs two-step screening |
| Hung, 2015/Taiwan58 | Before–after retrospective cohort study | 6697 | Singleton pregnancies >24 weeks without ODIP | One-step IADPSG screening (P2) vs two-step screening (50g GCT followed by 100g 3h OGTT with CC criteria if the GCT ≥7.8 mmol/L) (P1) | GDM incidence increased from 4.6% in P1 to 12.4% in P2. Adoption of the IADPSG criteria led to a significant reduction in maternal weight gain during pregnancy, birth weight, and the rates of macrosomia and LGA |
| Meek, 2015/UK60 | Retrospective study | 25,543 | Singleton pregnancies without ODIP | One-step IADPSG criteria vs one-step NICE 2015 criteria for GDM screening | The IADPSG criteria identified women at substantial risk of complications such as LGA who would not be identified by the NICE 2015 criteria |
| Feldman, 2016/ US52 | Before–after retrospective cohort study | 6066 | Singleton pregnancies without ODIP | One-step (IADPSG criteria) vs two-step GDM screening (CC criteria) | The IADPSG screening method was associated with a higher rate of GDM (27% vs 17%) but not with a reduction in LGA newborns or cesarean deliveries |
| March, 2016/ US53 | Retrospective cohort study | 235 | Singleton pregnancies | One-step (IADPSG) vs two-step (NDDG criteria) GDM screening | The one-step method identified women with at least equally high risk of adverse outcomes as the two-step method |
| Waters, 2016/North America48 | Secondary analysis of prospectively collected data | 6159 | Singleton pregnancies without ODIP and fertility treatment | GDM based on CC criteria (also GDM based on IADPSG criteria) vs GDM diagnosed with IADPSG criteria but not CC criteria vs no GDM | Women diagnosed with GDM based on IADPSG criteria had higher adverse outcome frequencies compared with women without GDM |
| Huhn, 2017/Switzerland43 | Retrospective cohort study | 1367 allocated | Women with singleton pregnancy and without ODIP | Two-step screening with 50 g GCT and 2h 75g OGTT (period 1) vs one-step 75g OGTT with IADPSG criteria (period 2) | Introduction of the IADPSG criteria resulted in an absolute increase of GDM prevalence of 8.5% (3.3% in period 1 to 11.8% in period 2) |
| Adam, 2017/South Africa44 | Prospective cohort study | 554 | All pregnant women <26 weeks | IADPSG vs NICE vs WHO 1999 vs Western Cape criteria using universal or selective screening | Substantial increase in prevalence of GDM with use of the IADPSG criteria, regardless of universal or selective screening |
| Luewan, 2018/Thailand46 | Prospective descriptive study | 648 | Singleton pregnancies excluding those with high risk for GDM | One-step (IADPSG) vs two-step GDM screening based on preference | Prevalence of GDM was significantly higher in the one-step group (32.0% vs 10.3%) without clear evidence of better outcomes |
| Goedegebure, 2018/the Netherlands55 | Multicenter retrospective cohort study | 1386 | Singleton pregnancies without ODIP | WHO-2013 (IADPSG) vs WHO-1999 GDM criteria | Using WHO-2013 criteria resulted in earlier GDM diagnosis, less need for insulin treatment and more spontaneous deliveries, but no differences in adverse pregnancy outcomes compared to WHO-1999 criteria |
| Benhalima, 2018 (Diabetes Care)/Belgium89 | Multicentric prospective cohort study | 2006 | Singleton pregnancies without ODIP and history of bariatric surgery | Sensitivity and specificity of the 50g GCT in a universal two-step screening strategy for GDM using IADPSG criteria vs a universal one-step screening with the 75g OGTT and IADPSG criteria | The GCT has a moderate diagnostic accuracy in a universal two-step screening strategy with IADPSG criteria; lowering the threshold for the GCT from 7.8 to 7.2 mmol/L would increase sensitivity from 60% to 72% and more than 60% of all OGTTs could be avoided |
| Pocobelli, 2018/US54 | Before–after cohort study | 23,257 | Singleton live birth deliveries in women without ODIP | Two-step screening with 50g GCT/FPG test followed by a 3h 100g OGTT vs one-step IADPSG screening | Adopting the one-step approach was associated with an increase in GDM diagnosis (by 41%), and in rates of labor induction and neonatal hypoglycemia, without association with other outcomes including cesarean delivery or macrosomia |
| Costa, 2019/Belgium51 | Retrospective cohort study | 6051 | Singleton pregnancies without ODIP | Two-step (50g GCT and 75g OGTT if GCT ≥7.8 mmol/L; CC criteria) vs one-step screening (IADPSG criteria) | GDM prevalence increased from 3.4% to 16.3%, without having a statistically significant impact on pregnancy outcomes |
| Cade, 2019/Australia57 | Quasi-experimental retrospective study | 14,498 | Singleton pregnancies without ODIP | 1991/1998 ADIPS criteria vs IADPSG criteria | Adoption of IADPSG criteria increased the incidence of GDM by 74% and the overall cost of care without obvious changes in immediate clinical outcomes |
| Meloncelli, 2020/Australia47 | Pre–post comparison study | 124,117 | All pregnant women giving birth >24 weeks | Two-step process and 1998 ADIPS GDM diagnostic criteria (in 2014) vs one-step process and IADPSG criteria (in 2016) | GDM diagnosis increased from 8.7% to 11.9%, with no observed changes to measured perinatal outcomes, except for a very small decrease in respiratory distress |
| RCTs | |||||
| Mirzamoradi, 2015/Iran61 | RCT | 189 | Singleton pregnancies without ODIP, with a disturbed FPG or blood sugar at the OGTT | Interventional (one-step screening with IADPSG criteria) vs control group (two-step GDM screening according to ACOG recommendation and CC/NDDG criteria) | Although the treatment of mild GDM (IADPSG) could not significantly decrease severe gestational outcomes, it did significantly reduce the risk of hyperbilirubinemia (OR 0.25) and its subsequent complications |
| Abebe, 2017 (ongoing)/US65 | RCT | 921 | Pregnant women from 18 to 28 weeks gestation | 50g GCT for all participants, then 1:1 randomization in 75g (one-step, IADPSG) or 100g (two-step, CC) OGTT | No results published yet |
| Satodiya, 2017/India62 | RCT | 1000 | Pregnant women without ODIP | Two-step screening (ACOG recommendation, group A) vs one-step screening (IADPSG criteria, group B) | Incidence of GDM using IADPSG criteria was almost doubled (11.8% vs 19.2%), whereas maternal and fetal outcomes were comparable, except in 15.8% women diagnosed as GDM and suffered from hypoglycemia |
| Fadl, 2019 (ongoing)/Sweden64 | RCT | ± 65,000 | Pregnant women without ODIP | Intervention (WHO 2013 criteria) vs control group (former Swedish diagnostic criteria) | No results published yet (expected in 2020) |
| Hillier, 2021/US63 | RCT | 23,792 | Singleton pregnancies without history of bariatric surgery | One-step (2h 75g OGTT according to IADPSG criteria) vs two-step GDM screening (1h 50g GCT and a 3h 100g OGTT according to CC criteria) | Despite more diagnoses of GDM with the one-step approach (16.5% vs 8.5%), there were no significant differences in the risks of the primary outcomes relating to perinatal and maternal complications |
Abbreviations: UAE, United Arab Emirates; IADPSG, International Association of the Diabetes and Pregnancy Study Groups; GDM, gestational diabetes mellitus; ADA, American Diabetes Association; ODIP, overt diabetes in pregnancy; HbA1c, hemoglobin A1C; CC, Carpenter and Coustan; OGTT, oral glucose tolerance test; GCT, glucose challenge test; LGA, large-for-gestational age; NICE, National Institute for Health and Care Excellence; NDDG, National Diabetes Data Group; WHO, World Health Organization; FPG, fasting plasma glucose; ADIPS, Australasian diabetes in pregnancy society; RCT, randomized controlled trial; ACOG, American Congress of Obstetricians and Gynecologists.