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Table 3 Challenge phase studies (CPS) details: sensibility/sensitivity results and need of Advanced Phase studies (APN)

From: The diagnostic indicators of gestational diabetes mellitus from second trimester to birth: a systematic review

Author & Year

Ref N

Design: N of patients

OGTT Criteria

Marker and thresholds

Sensitivity

Specificity

CASP Score

Notesa

Trujillo 2014

[15]

CC: 4040 NGT, 886 GDM

IADPSG

Fasting blood glucose > A = 80, B = 85 mg/dl

A = 97% B = 93%,

A = 55% B = 78%

9

A/C

Ruetschi 2016

[31]

COH: 2047 NGT, 251 GDM

IADPSG

Fasting blood glucose > 4.4 mmol⁄ l

79%

69%

8

C/C

D’emden 2020

[32]

COH: 3946 GDM, 22,296 NGT

IADPSG

Fasting blood glucose > 4.6 mmol⁄ l

54%

77%

8

C/C

Anjalakshi 2009

[126]

COH: 713 NGT, 87 GDM

WHO 99

Non fasting OGTT

100%

100%

8

A/A: APN

Kwon 2015

[35]

COH: 242 GDM,79 NGT

C&C

Glycated haemoglobin (HbA1C) > A = 5.05, B = 5.25%

A = 91%

B = 74%

A = 62%

B = 77%

9

A/C

C/C

Renz 2015

[36]

COH: 176 NGT,86 GDM

C&C /IADPSG

Glycated haemoglobin (HbA1C) > A = 6.5, B = 5.8, C = 5.0%

A = 7%

B = 26%

C = 90%

A = 100%

B = 95%

C = 33%

11

D/A

D/A

A/D

Rajput 2012

[34]

COH: 43 GDM, 560 NGT

C&C /IADPSG

Glycated haemoglobin (HbA1C) > A = 5.95, B = 5.45,C = 5.45—5.95%,

A = 29%

B = 86%

C = 86%

A = 97%

B = 61%

C = 3%

9

B/C

Siricharoenthai 2020

[37]

CC: 35 GDM, 79 NGT

NDDG

Glycated haemoglobin (HbA1C) > 5.8%

17%

100%

8

D/A

Khan 2020

[38]

P. COH: 50 GDM, 230 NGT

IADPSG

Glycated haemoglobin (HbA1C) > 6.06%

70%

84.8%

8

C/B

Lai 2020

[40]

R.COH: 3547 GDM, 15,714 NGT

IADPSG

Glycated haemoglobin (HbA1C) > 5.0%

60.1%

65.3%

8

C/C

Rayis 2020

[39]

P. COH: 68 GDM, 272 NGT

IADPSG

Glycated haemoglobin(HbA1C) > A = 4.1%, B = 5.8%

A = 76.5% B = 13.4%

A = 37.8% B = 91.4%

8

A = C/D

B = D/A

Ghosh 2017

[33]

CC: 500 NGT, 127 GDM

C&C

Glycated CD59 = cut-off not specified

85%

92%

10

B/A: APN

Cakmak 2019

[103]

CC: 60 GDM, 75 NGT

C&C

Vascular adhesion protein 1 (VAP-1) > 2.3

70%

65.3%

8

C/C

Tekin 2020

[127]

CC: 30 NGT, 50 GDM

IADPSG

Signal peptide-CUB-EGF domain-containing protein (SCUBE)-1 > 36.8 ng/mL

93.1%

74.2%

10

A/C

Dudzik  2015

[42]

CC: 20 GDM, 30 NGT

WHO 5.6,8.9,7.8

LPE(20:1), (20:2), (22:4); LPC(18:2), (20:4), (20:5); LPI(18:2), (20:4); LPS(20:0) and LPA(18:2)

All 100%

All 95%

9

A/A: LCPSN

Sanchez-Garcia 2020

[128]

P.COH: 38 GDM, 102 NGT

IADPSG

Triglyceride-glucose index (TyG) > 4.69 ng/mL

89%

50%

9

B/D

Gingras 2018

[129]

P.COH: 73 GDM, 1415 NGT

C&C

Fructosamine > 222 _mol/L

55%

49%

9

C/C

Koroglu 2019

[90]

CC: 50 GDM, 30 NGT

IADPSG

Pancreatic-derived factor (PANDER) > 227.2 ng/ml

100%

87%

9

A/B: LCPSN

Pan 2019

[63]

COH: 96 GDM,304 NGT

IADPSG

Betatrophin > 106 pg/mL

69%

84%

9

C/C

Fatima 2017

[20]

CC: 208 GDM, 300 NGT

IADPSG

A = CHEMERIN > 415.49 ng/ml

B = LEPTIN > 48.5 ng/ml

A = 96%

B = 90%

A = 72%

B = 96%

9

A = A/C

B = A/A: APN

Yuan 2018

[29]

COH: 87 GDM, 273 NGT

IADPSG

Ficolin-3/adiponectin ≥ 1.06

91%

97%

11

A/A: APN

Ning 2016

[83]

CC: 46 GDM,55 NGT

IADPSG

FABP4 > 1.96 ng/mL

89%

87%

10

B/B: APN

Wang 2020

[130]

CC: 60 GDM, 50 NGT

IADPSG

Fatty acid-binding protein 4 (FABP4) > 27.64

Chemerin > 6.78

Chemerin + FABP > 0.71

75%

73.3%

80%

80%

76%

96%

10

C/B

B/B

B/A: APN

Tawfeek 2017

[68]

CC: 45 GDM, 45 NGT

IADPSG

Sex hormone binding globulin (SHBG) > 50 nmol/L

90%

96%

10

A/A: LCPSN

Amirian 2019

[66]

P. COH: 63 GDM, 460 NGT

IADPSG

Unconjugated Estriol (UE) > 0.965 MOM

66.6%

54.8%

11

C/C

Yilmaz 2014

[131]

CC: 42 GDM, 68 NGT

C&C

Neutrophil to Lymphocyte Ratio (NLR) > 2.93

76%

94%

9

C/B

Butt 2017

[132]

CC: 59 GDM, 41 NGT

IADPSG

Cobalamin > 113 pg/mL

57%

80%

10

C/B

Giacobbe 2016

[133]

CC: 75 GDM,48 NGT

IADPSG

High mobility group box 1 > 1.85 ng/ml

81%

96%

11

B/A:APN

Shaas 2017

[82]

CC: 50 GDM,50 NGT

IADPSG

risk factors + HBA1c + SHBG + PAPP-A + CRP

75%

91%

10

C/A

Thériault 2016

[81]

CC: 264 GDM,528 NGT

IADPSG

previous GDM, family history of diabetes and soft drink intake before pregnancy + HbA1c + SHBG + BMI

69%

90%

12

C/A

Tantanasis 2010

[14]

CC: 20 GDM, 15 NGT

WHO 99

Fetus maximum subcutaneous fat tissue thickness > 3.950 mm at HC, 4.550 mm at AC and 4.700 mm at TS

100%

100%

11

A/A: LCPSN

Kansu-Celick 2018

[108]

COH: 46 GDM,177 NGT

C&C

Maternal Subcutaneous adipose tissue (SAT) thickness > 16.75 mm

72%,

58%

9

C/C

Aydin 2020

[115]

CC: 60 GDM, 60 NGT

C&C /IADPSG

Fetal epicardial fat thickness (fEFT) > 0.95 mm

65%

88%

8

C/B

İlhan 2018

[111]

CC: 33 GDM, 64 NGT

IADPSG

Fetal liver volume (FLV) > 32.72 cm3

79%

56%

9

C/C

Perovic 2012

[117]

COH: 33 GDM, 77 NGT

C&C

Ultrasound Gestational Diabetes Screening Score (UGDS)c > 4

B = 91%,

B = 90%

11

A/A: APN

  1. aA = very good sensitivity/specificity (> 90%), B = good sensitivity/specificity (80–89%), C = low sensitivity/specificity (70–79%), D = very low sensitivity/specificity (< 70%); LCPSN = Larger Challenge Phase Study Needed if population < 100
  2. bUGDS score = Increased adipose subcutaneous tissue, cardiac width, cardiac circumference, placental thickness, Polyhydramnion, Asymmetrical macrosomia, Thickened intra-ventricular septum, Intensified breathing movements, Immature appearance of placenta