Discussion
macrosomia, non-GDM, GDM
GDM, SECONDARY, CHRONIC DISORDERS, HYPOGLYCEMIA
In this secondary analysis of a randomized field trial among pregnant women, we found that the rates of GDM more than doubled with the One-step strategy. However, despite a significantly larger percentage of women who were diagnosed and subsequently managed for GDM in the One-step approach, the risk of adverse maternal and neonatal outcomes were similar in both groups, suggesting that many of the cases diagnosed with the lower threshold of the One-step method may not require specific GDM treatment.Up to now, there is no worldwide consensus about optimum approach to diagnose GDM. Major scientific bodies acknowledge both One- and Two-step screening methods of GDM, but emphasize the need for additional evidence related to outcomes (The results of our study are in agreement with the majority of the available literature that the One-step approach led to higher GDM prevalence among pregnant women (In agreement with our findings, in recently published meta-analyses, which involved 50 population-based studies and more than 1.5 million pregnant women with GDM and 7.5 million non-GDM counterparts, it was reported that applying the IADPSG criteria for GDM diagnosis could significantly increase the prevalence of GDM, while it could not improve the risk of adverse pregnancy outcome compared other criteria (However, the findings of our community randomized trial showed that while the adoption of One-step screening could increase the prevalence of GDM, it could, however, not improve pregnancy outcomes. The results of this study are clinically valuable because this is the first community-based trial in a developing country where the rate of GDM is high (Additionally, the over-diagnosis may lead to psychological presser and impaired quality of life of pregnant women (It should be noted that the rate of macrosomia in this study was low. We hypothesized that this phenomenon may be related to ethnicity differences of Iranian population (However, this study was one of the largest community-based trials in the developing country that may cover the gap of knowledge that arises from previous studies. One of the important strengths of our study is the generalizability of findings due to its characteristics, including its design as a community-based trial, large sample size, the geographic distribution of the regions involved, and using similar laboratory protocols. In addition, the adherence to each protocol in our study was high (Nevertheless, we were limited by excluding women with known chronic disorders, since based on our national guidelines, those women should visit the second and third level of the health care delivery system directly and not receive prenatal care in a primary healthcare setting, which was the platform of our study. Moreover, in this study, we did not assess the long-term benefits of the One- and Two-step approaches of GDM screening, such as improved long-term metabolic or cardiovascular health, for mothers and their offspring. We did not have the results of IV therapy for those neonates with hypoglycemia. Additionally, a central reference laboratory was not used for all our measurements, though all laboratory procedures, equipment, and supplies were homogeneous in different geographical regions of the study, and monthly external quality controls were performed for each laboratory to confirm the validity and reliability of all laboratory measures.