Does fasting plasma glucose values 5.1-5.6 mmol/l in the first trimester of gestation a matter?

Objectives: The aim of the study was to investigate the effect of treatment on pregnancy outcomes among women who had fasting plasma glucose (FPG) 5.1-5.6 mmol/l in the first trimester of pregnancy. Methods: We performed a secondary-analysis of a randomized community non-inferiority trial of gestational diabetes mellitus (GDM) screening. All pregnant women with FPG values range 5.1-5.6 mmol/l in the first trimester of gestation were included in the present study (n=3297) and classified to either the (i) intervention group who received treatment for GDM along with usual prenatal care (n=1,198), (ii) control group who received usual-prenatal-care (n=2,099). Macrosomia/large for gestational age (LGA) and primary cesarean-section (C-S) were considered as primary-outcomes. A modified-Poisson-regression for binary outcome data with a log link function and robust error variance was used to RR (95%CI) for the associations between GDM status and incidence of pregnancy outcomes. Results: The mean maternal age and BMI of pregnant women in both study groups were similar. There were no statistically significant differences in the adjusted risks of adverse pregnancy outcomes, including macrosomia, primary C-S, preterm birth, hyperbilirubinemia, preeclampsia, NICU-admission, birth trauma, and LBW both groups. Conclusions: It is found that treating women with first-trimester FPG values of 5.1-5.6 mmol/l could not improve adverse pregnancy outcomes including macrosomia, Primary C-S, Preterm birth, hypoglycemia, hypocalcemia, preeclampsia, NICU admission, Birth trauma and LBW. Therefore, extrapolating the FPG cut-off point of the second trimester to the first -which has been proposed by the IADPSG, might therefore not be appropriate. Clinical Trial Registration: https://www.irct.ir/trial/518, identifier IRCT138707081281N1.

A Cluster Randomized Noninferiority Field Trial of Gestational Diabetes Mellitus Screening.

CONTEXT: Although it is well-acknowledged that gestational diabetes mellitus (GDM) is associated with the increased risks of adverse pregnancy outcomes, the optimal strategy for screening and diagnosis of GDM is still a matter of debate. OBJECTIVE: This study was conducted to demonstrate the noninferiority of less strict GDM screening criteria compared with the strict International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria with respect to maternal and neonatal outcomes. METHODS: A cluster randomized noninferiority field trial was conducted on 35 528 pregnant women; they were scheduled to have 2 phases of GDM screening based on 5 different prespecified protocols including fasting plasma glucose in the first trimester with threshold of 5.1 mmol/L (92 mg/dL) (protocols A, D) or 5.6 mmol/L (100 mg/dL) (protocols B, C, E) and either a 1-step (GDM is defined if one of the plasma glucose values is exceeded [protocol A and C] or 2 or more exceeded values are needed [protocol B]) or 2-step approach (protocols D, E) in the second trimester. Guidelines for treatment of GDM were consistent with all protocols. Primary outcomes of the study were the prevalence of macrosomia and primary cesarean section (CS). The null hypothesis that less strict protocols are inferior to protocol A (IADPSG) was tested with a noninferiority margin effect (odds ratio) of 1.7. RESULTS: The percentages of pregnant women diagnosed with GDM and assigned to protocols A, B, C, D, and E were 21.9%, 10.5%, 12.1%, 19.4%, and 8.1%, respectively. Intention-to-treat analyses satisfying the noninferiority of the less strict protocols of B, C, D, and E compared with protocol A. However, noninferiority was not shown for primary CS comparing protocol E with A. The odds ratios (95% CI) for macrosomia and CS were: B (1.01 [0.95-1.08]; 0.85 [0.56-1.28], C (1.03 [0.73-1.47]; 1.16 [0.88-1.51]), D (0.89 [0.68-1.17]; 0.94 [0.61-1.44]), and E (1.05 [0.65-1.69]; 1.33 [0.82-2.00]) vs A. There were no statistically significant differences in the adjusted odds of adverse pregnancy outcomes in the 2-step compared with the 1-step screening approaches, considering multiplicity adjustment. CONCLUSIONS: The IADPSG GDM definition significantly increased the prevalence of GDM diagnosis. However, the less strict approaches were not inferior to other criteria in terms of adverse maternal and neonatal outcomes.

Prevalence and Risk Factors of Low Birth Weight in the Southeast of Iran.

BACKGROUND: The purpose of this study was to determine the prevalence and related factors of low birth weight (LBW) in the Southeast of Iran. METHODS: This cross-sectional study was carried out in Kerman province. Data were collected from Iranian Maternal and Neonatal Network at public and private hospitals. All live births from March 2014 to March 2015 considered as the source population. The risk factors including maternal age, gravida, parity, abortion, pregnancy risk factors, maternal nationality, maternal education, maternity insurance, place of living, consanguinity, neonate sex, preterm labor, place of birth, delivery manager, and delivery type were compared between LBW and normal birth weight groups. RESULTS: The prevalence of LBW was 9.4% in the present study. Preterm labor (odds ratio [OR]: 22.06; P < 0.001), neonate female sex (OR: 1.41; P < 0.001), low parity (OR: 0.85; P < 0.001), pregnancy age <18 years (OR: 1.26; P = 0.012), pregnancy age >35 years (OR: 1.21; P = 0.001), delivery by cesarean section (OR: 1.17; P = 0.002), pregnancy risk factors (OR: 1.67; P < 0.001), maternal illiteracy (OR: 1.91; P < 0.001), living in the rural area (OR: 1.19; P < 0.001), consanguineous (OR: 1.08; P = 0.025), and delivery by obstetrician (OR: 1.12; P = 0.029) were identified as significant factors associated with LBW in this study. CONCLUSIONS: Prevention of preterm labor, consanguineous marriage, pregnancy age <18 and >35 years old, and maternal medical risk factors are some critical interventions to reduce its burden. Increasing the access to high-quality health-care services in rural and deprived areas is another effective strategy for the prevention of LBW.