ABSTRACT
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.
Subject(s)
Diabetes, Gestational , Pre-Eclampsia , Premature Birth , Female , Humans , Infant, Newborn , Pregnancy , Blood Glucose , Diabetes, Gestational/diagnosis , Diabetes, Gestational/epidemiology , Fasting , Fetal Macrosomia/epidemiology , Pregnancy Outcome/epidemiology , Pregnancy Trimester, First , Premature Birth/epidemiologyABSTRACT
OBJETIVO: Avaliar a reprodutibilidade interobservador dos índices de vascularização do Doppler de amplitude tridimensional (Doppler de amplitude 3D) no primeiro trimestre de gestação. MATERIAIS E MÉTODOS: Realizou-se estudo de reprodutibilidade com 32 gestantes normais entre 7 e 10 semanas e 6 dias. Para o cálculo do volume tridimensional dos embriões utilizou-se o método VOCAL (Virtual Organ Computer-aided AnaLysis) com ângulo de rotação de 12°. Em seguida obtiveram-se, automaticamente, os três índices vasculares do Doppler de amplitude 3D: índice de vascularização (VI), índice de fluxo (FI) e índice de vascularização e fluxo (VFI). Para o cálculo da variabilidade interobservador, um examinador realizou uma segunda medida dos 32 embriões e um segundo examinador realizou uma terceira medida dos mesmos volumes, ambos desconhecendo os resultados do outro. Utilizaram-se, para análise estatística, o coeficiente de correlação intraclasse (CCI) e gráficos de Bland-Altman. RESULTADOS: Observou-se boa reprodutibilidade interobservador dos três índices vasculares. O VI apresentou CCI = 0,9 e média da diferença = -1,1; o FI apresentou CCI = 0,9 e média da diferença = -0,5; e o VFI apresentou CCI = 0,9 e média da diferença = -1,1. CONCLUSÃO: Os índices vasculares do Doppler de amplitude 3D do embrião no primeiro trimestre de gestação foram altamente reprodutíveis, em especial o FI.
OBJECTIVE: To evaluate the interobserver reproducibility of vascular indices obtained with three-dimensional power Doppler (3D power Doppler) ultrasonography at the first trimester of gestation. MATERIALS AND METHODS: The present reproducibility study involved 32 healthy pregnant women with 7 to 10 weeks and 6 days of gestation. The VOCAL (Virtual Organ Computer-aided AnaLysis) method was utilized to calculate embryos volume, with a 12° rotational angle. Subsequently, the software automatically displayed three 3D power Doppler vascular indices: vascularization index (VI), flow index (FI) and vascularization and flow index (VFI). In order to calculate the interobserver variability, an investigator performed a second blind measurement of the 32 embryos, and another investigator performed a third blind measurement of the same volumes. The interclass correlation coefficient (ICC) and Bland-Altman plots were utilized for statistical analysis. RESULTS: A good interobserver reproducibility was observed in relation to the three vascular indices. The VI presented ICC = 0.9 and mean difference between measurements = -1.1. For the FI, the ICC was 0.9 and mean difference = -0.5. The VFI presented ICC = 0.9 and mean difference = -1.1. CONCLUSION: The vascular indices, particularly the FI, obtained with 3D power Doppler ultrasonography at the first trimester of gestation demonstrated a high reproducibility.