Cost effectiveness of different screening strategies for gestational diabetes mellitus screening: study protocol of a randomized community non-inferiority trial

Abstract Background There is lack of ideal and comprehensive economic evaluations of various GDM strategies. The aim of this study is to the compare efficacy and cost-effectiveness of five different methods of screening for gestational diabetes mellitus (GDM). Methods This study is a randomized community non-inferiority trial among 30,000 pregnant women in five different geographic regions of Iran, who were randomly assigned to one of the five GDM screening methods. All first trimester pregnant women, seeking prenatal care in governmental health care systems, who met our eligibility criteria were enrolled. The criteria suggested by the International-Association-of-Diabetes-in-Pregnancy-Study-Group, the most intensive approach, were used as reference. We used the non-inferiority approach to compare less intensive strategies to the reference one. Along with routine prenatal standard care, all participants were scheduled to have two phases of GDM screening in first and second-trimester of pregnancy, based on five different pre-specified protocols. The screening protocol included fasting plasma glucose in the first trimester and either a one step or a two-step screening method in the second trimester of pregnancy. Pregnant women were classified in three groups based on the results: diagnosed with preexisting pre-gestational overt diabetes; gestational diabetes and non-GDM women. Each group received packages for standard-care and all participants were followed till delivery; pregnancy outcomes, quality of life and cost of health care were recorded in detail using specific standardized questionnaires. Primary outcomes were defined as % birth-weight > 90th percentile and primary cesarean section. In addition, we assessed the direct health care direct and indirect costs. Results This study will enable us to compare the cost effectiveness of different GDM screening protocols and intervention intensity (low versus high). Conclusion Results which if needed, will also enable policy makers to optimize the national GMD strategy as a resource for enhancing GDM guidelines. Trial registration Name of the registry: Iranian Registry of Clinical Trials. Trial registration number: IRCT138707081281N1. Date of registration: 2017-02-15. URL of trial registry record: https://www.irct.ir/trial/518

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Higher mean amplitude of glycaemic excursion in the second trimester of pregnancy is associated with the subsequent development of gestational diabetes mellitus: an observational study

10.22541/au.163843479.99686909/v1 ◽

2021 ◽

Author(s):

Phaik Ling Quah ◽

Kok Hian Tan ◽

Nurul Razali ◽

Nurul Sakinah Razali

Keyword(s):

Diabetes Mellitus ◽

Blood Glucose ◽

Gestational Diabetes ◽

Observational Study ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Subsequent Development ◽

Mean Amplitude ◽

First Trimester ◽

Second Trimester

Objective: To examine glycaemic variability (GV) and glycaemic control (GC) parameters in early pregnancy with subsequent development of gestational diabetes mellitus (GDM). Design: Longitudinal observational study. Setting: Pregnant women from KK Women and Children’s Hospital in Singapore Participants: 51 study participants in the first trimester (9-13 weeks’ gestational), and 44 participants (18-23 weeks’ gestation) in the second trimester of pregnancy. Methods: Independent t-tests were used to examine the differences in the parameters between participants who developed GDM and those who did not. Main outcome measure: GDM was determined at 24-30 weeks’ gestation using oral glucose tolerance test (OGTT). GV parameters examined were, mean amplitude of glycaemic excursion (MAGE), standard deviation of blood glucose (SDBG) and mean of daily continuous 24 h blood glucose (MBG) and coefficient of variation (CV). GC parameters measured were, J-Index and % time spent in glucose target ranges. Results: In the second trimester of pregnancy, mean amplitude of glycaemic excursions (MAGE) was significantly higher in participants who subsequently developed GDM, compared to those who did not (mean (SD): 3.18(0.68) vs 2.60(0.53), p=0.02). Other study parameters measured in the second trimester of pregnancy were not significantly different between groups. There were no significant associations between all the GV and GC parameters determined from the CGM in the first trimester with subsequent development of GDM (p>0.05). Conclusion: MAGE is an important GV parameter associated to the development of subsequent GDM in pregnant women. The findings highlight the potential value of CGM in gestational glycaemic profiling.

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Correlation of serum biomarkers in prediction of gestational diabetes mellitus

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20174413 ◽

2017 ◽

Vol 6 (10) ◽

pp. 4402

Author(s):

Maya Menon ◽

M. Alaganandha ◽

Jayanthi Mohan

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

First Trimester ◽

Study Groups ◽

Serum Biomarkers ◽

P Value ◽

Second Trimester ◽

The Difference

Background: Adiponectin and Leptin are adipokines produced by adipocytes. TNF-alpha and IL-6 are inflammatory cytokines which increases insulin resistance. Decreased adiponectin, increased leptin, TNF-alpha and IL-6 is associated with risk of Gestational Diabetes Mellitus, characterised by glucose intolerance that begins or first recognised in pregnancy leading to maternal and foetal complications. India has a high prevalence of GDM upto 16.55% by (2hr plasma glucose of more than 140mg/dl). We aimed to evaluate whether ‘First trimester serum biomarkers predict gestational diabetes mellitus’. The objective of the study was to study the serum biomarkers levels in early pregnancy and predict the risk of developing gestational diabetes mellitus. To study the correlation of serum biomarkers levels in gestational diabetes mellitus.Methods: The study was conducted between October 2014 to March 2016 in healthy pregnant women aged 20-35 yrs attending the antenatal OPD in ESIC Hospital. Study design: Prospective observational study with three study groups 1. NGT, 2. GDM1, 3. GDM2 with two-time points one at first trimester and other second trimester. Sample size: 125 pregnant women. Work plan: Demographics, baseline characteristics and other clinical risk factors of pregnant women in 1st trimester who consented for the study, meeting the inclusion criteria are noted. 75 gm OGCT (oral glucose challenge test) done at two-time points first and second trimester in the study groups will be analysed using the DIPSI criteria with a cut-off value ≥140mg/dl and divided into 3 groups. Serum biomarkers were measured by DRG ELISA method at one-time point in first trimester in all the 3 groups.Results: The serum levels of adiponectin are comparatively reduced in first trimester GDM1 group. As the difference was not significant with p-value of 0.33 there was no correlation between adiponectin and GDM in our study. Serum leptin is increased in second trimester GDM group but the difference is insignificant with a p value of 0.11 showing no correlation.Conclusions: Among the cytokines IL-6 also shows an increasing tendency in both GDM1 (5.9±0.57) and GDM2 (6.04±1.04) groups compared to the NGT (5.82±0.38) group. Serum TNFα is increased in GDM1 (17.29±17.14) and NGT (17.03±24.03) compared to GDM2 (13.54±17.29) group.

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86-LB: Elevated First-Trimester Neutrophil Count Is Associated with the Development of Gestational Diabetes Mellitus in Pregnant Women

Diabetes ◽

10.2337/db19-86-lb ◽

2019 ◽

Vol 68 (Supplement 1) ◽

pp. 86-LB

Author(s):

TIANGE SUN ◽

FANHUA MENG ◽

RUI ZHANG ◽

ZHIYAN YU ◽

SHUFEI ZANG ◽

...

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Neutrophil Count ◽

First Trimester

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Plasma retinol-binding protein 4 in the first and second trimester and risk of gestational diabetes mellitus in Chinese women: a nested case-control study

Nutrition & Metabolism ◽

10.1186/s12986-019-0425-9 ◽

2020 ◽

Vol 17 (1) ◽

Cited By ~ 1

Author(s):

Chuyao Jin ◽

Lizi Lin ◽

Na Han ◽

Zhiling Zhao ◽

Zheng Liu ◽

...

Keyword(s):

Diabetes Mellitus ◽

Insulin Resistance ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Binding Protein ◽

First Trimester ◽

Retinol Binding Protein ◽

Second Trimester ◽

Retinol Binding Protein 4 ◽

Plasma Retinol

Abstract Background To assess the association between plasma retinol-binding protein 4 (RBP4) levels both in the first trimester and second trimester and risk of gestational diabetes mellitus (GDM). Methods Plasma RBP4 levels and insulin were measured among 135 GDM cases and 135 controls nested within the Peking University Birth Cohort in Tongzhou. Multivariable linear regression analysis was conducted to assess the influence of RBP4 levels on insulin resistance. Conditional logistic regression models were used to compute the odds ratio (OR) and 95% confidence interval (CI) between RBP4 levels and risk of GDM. Results The GDM cases had significantly higher levels of RBP4 in the first trimester than controls (medians: 18.0 μg/L vs 14.4 μg/L; P < 0.05). Plasma RBP4 concentrations in the first and second trimester were associated with fasting insulin, homeostasis model assessment for insulin resistance (HOMA-IR), and the quantitative insulin sensitivity check index (QUICKI) in the second trimester (all P < 0.001). With adjustment for diet, physical activity, and other risk factors for GDM, the risk of GDM increased with every 1-log μg/L increment of RBP4 levels, and the OR (95% CI) was 3.12 (1.08–9.04) for RBP4 in the first trimester and 3.38 (1.03–11.08) for RBP4 in the second trimester. Conclusions Plasma RBP4 levels both in the first trimester and second trimester were dose-dependently associated with increased risk of GDM.

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Leptin, resistin and visfatin as useful predictors of gestational diabetes mellitus

Lipids in Health and Disease ◽

10.1186/s12944-019-1169-2 ◽

2019 ◽

Vol 18 (1) ◽

Cited By ~ 6

Author(s):

Ahmed Tijani Bawah ◽

Mohammed Mustapha Seini ◽

Albert Abaka-Yawason ◽

Huseini Alidu ◽

Salifu Nanga

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Operating Characteristic ◽

Case Control Study ◽

First Trimester ◽

Anthropometric Parameters ◽

Receiver Operating Characteristic Curves ◽

Control Study

Abstract Background Lipids and adipokines including leptin, resistin and visfatin play various roles in the pathophysiology of Gestational Diabetes Mellitus (GDM). This study was aimed at determining whether serum leptin, resistin and visfatin are significantly altered during the first trimester of pregnancies that subsequently develop GDM and whether such changes are useful in predicting the disease. Methods This was a case-case control study which compared first trimester biochemical and anthropometric parameters in 70 pregnant women who subsequently developed GDM and 70 pregnant women without GDM at the Volta Regional Hospital, Ho, Ghana. Lipid profile and some selected adipokines were analyzed and first trimester body mass index (BMI) was determined. Results There were significant differences (p < 0.05) in leptin, resistin, and visfatin as well as significant dyslipidemia among those with GDM compared to those without GDM. Furthermore, the area under the Receiver Operating Characteristic Curves (AUCs) for leptin, resistin and visfatin were; 0.812, 0.836 and 0.799 respectively. Increased first trimester leptin (OR = 1.166; CI = 1.104–1.233; p < 0.0001), resistin (p < 0.0001) and visfatin (p < 0.0001) were associated with GDM. Conclusion Hyperleptinemia, hyperesistinemia and hypervisfatinemia precede GDM and can serve as good predictive indices for gestational diabetes mellitus.

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Correlation between first trimester uric acid level and subsequent development of gestational diabetes mellitus

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20170391 ◽

2017 ◽

Vol 6 (2) ◽

pp. 606

Author(s):

Amudha P. ◽

Nithya D. ◽

Pradeeba S. ◽

Manochithra B.

Keyword(s):

Diabetes Mellitus ◽

Uric Acid ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Serum Uric Acid ◽

Uric Acid Level ◽

Acid Level ◽

Subsequent Development ◽

First Trimester

Background: The aim of the study was to correlate between first trimester uric acid level and its association with subsequent development of gestational diabetes mellitus.Methods: This is a prospective study conducted at Govt. Raja Mirasudar Hospital attached to Thanjavur Medical College, Thanjavur over a period of one year from September 2015. A total of one hundred and eighty seven ante natal women less than 14 weeks of gestational age who attended the outpatient antenatal department were included in this study. Serum uric acid estimation was done in women with <14 weeks of gestation and they were subsequently screened for GDM between 24 to 28 weeks by oral glucose tolerance test (OGTT) with 75 gms glucose according to IADPSG criteria.Results: In our study, among 178 antenatal pregnant women 13 with uric acid >3.6 mg/dl and 2 with serum uric acid <3.6 mg/dl developed GDM. This shows development of GDM increases with increase in uric acid concentration.Conclusions: Though our study results suggest that serum uric acid level estimation in first trimester can be used as a marker to predict GDM in pregnant women, large scale studies are required before it can be recommended as a routine first trimester screening test for prediction of gestational diabetes mellitus.

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Changes of Serum Sex Hormone-Binding Globulin, Homocysteine, and Hypersensitive CRP Levels during Pregnancy and Their Relationship with Gestational Diabetes Mellitus

Gynecologic and Obstetric Investigation ◽

10.1159/000515085 ◽

2021 ◽

pp. 1-7

Author(s):

Wenhua Liu ◽

Zheren Huang ◽

Shanshan Tang ◽

Zhifen Zhang ◽

Qing Yu ◽

...

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Pregnant Women ◽

Serum Levels ◽

First Trimester ◽

Sex Hormone Binding Globulin ◽

Control Group ◽

Second Trimester ◽

Hormone Binding ◽

Hs Crp

Background: Inflammatory response state is related to the pathogenesis of gestational diabetes mellitus (GDM). Objective: To investigate the changes of serum sex hormone-binding globulin (SHBG), homocysteine (Hcy), and hypersensitive CRP (hs-CRP) levels during pregnancy and their relationship with GDM. Methods: The nested case-control study method was used. Sixty nonobese single pregnant women diagnosed with GDM were divided into the GDM group (GDM, n = 60), together with another 60 pregnant women with normal glucose tolerance who were matched in the same period and divided into the control group (control, n = 60). The serum Hcy, hs-CRP, and SHBG levels were measured. Results: The serum levels of Hcy and hs-CRP were significantly higher in the GDM group compared with the control group, and serum levels of SHBG was significantly lower in the GDM group compared with the control group at different stages of pregnancy. The serum levels of Hcy and hs-CRP in pregnant women increased with the increase of gestational age, and serum levels of SHBG decreased with the increase of gestational age. Increased Hcy and hs-CRP levels in the second trimester and decreased SHBG levels in the first trimester were related to GDM. The odds ratio (OR) and 95% confidence interval (CI) were as follows: OR: 4.5, 95% CI: 1.5–13.0; OR: 4.2, 95% CI: 1.5–10.1; and OR: 0.4, 95% CI: 0.3–0.7, respectively. Conclusion: Increased Hcy and hs-CRP in the second trimester and decreased SHBG in the first trimester were independent predictors of GDM, which provides a new idea for early prevention and treatment of GDM.

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First trimester serum concentrations of afamin are associated with the development of preeclampsia and gestational diabetes mellitus in pregnant women

Atherosclerosis ◽

10.1016/j.atherosclerosis.2016.07.463 ◽

2016 ◽

Vol 252 ◽

pp. e69-e70 ◽

Cited By ~ 1

Author(s):

A. Tramontana ◽

B. Dieplinger ◽

G. Stangl ◽

E. Hafner ◽

H. Dieplinger

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

First Trimester ◽

Serum Concentrations

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The joint prediction model of pBMI and eFBG in predicting gestational diabetes mellitus

Journal of International Medical Research ◽

10.1177/0300060519889199 ◽

2019 ◽

Vol 48 (4) ◽

pp. 030006051988919

Author(s):

Ying Pan ◽

Ji Hu ◽

Shao Zhong

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Roc Curve ◽

Predictive Value ◽

Fasting Blood Glucose ◽

First Trimester ◽

Credibility Interval ◽

Roc Curve Analysis

Objective To explore the predictive value of prepregnancy body mass index (pBMI) and early gestational fasting blood glucose (eFBG) in gestational diabetes mellitus (GDM). Methods This case–control study enrolled pregnant women at 6 to 16 weeks of gestation. The pBMI, eFBG and glycosylated haemoglobin (HbA1c) was recorded in the first trimester of pregnancy. Receiver-operating characteristic (ROC) curve analysis was used to measure the efficacy of factors that predict GDM. Results A total of 2119 pregnant women were enrolled in this study. Of these, 386 were diagnosed with GDM and 1733 did not have GDM. The age (odds ratio [OR] 1.16; 95% confidence interval [CI] 1.13, 1.20), pBMI (OR 1.12; 95% CI 1.07, 1.17) and eFBG (OR 5.37; 95% CI 3.93, 7.34) were independent risk factors for GDM occurrence. The areas under the ROC curve of eFBG, pBMI and eFBG + pBMI were 0.68 (95% credibility interval 0.65, 0.71), 0.66 (95% credibility interval 0.63, 0.69) and 0.71 (95% credibility interval 0.69, 0.74), respectively. The area under the curve of eFBG + pBMI was significantly higher than that of eFBG or pBMI alone. Conclusion The combination of eFBG and pBMI had a high predictive value for GDM.

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