Table 1.
Descriptive statistics of group-wise data and comparison by Mann-Whitney U test.
| Parameters | Normal Pregnant Women | Pregnant with Preeclampsia | p-value (Mann-Whitney U) |
|---|---|---|---|
| Age (in years) | 28 (25 – 30) | 28 (23 – 30) | 0.989 |
| Gestational Age (in weeks) | 36.3 (28.85 – 38.35) | 36.9 (33.8 – 38.15) | 0.698 |
| Weight (in kg) | 55.5 (51 – 62.5) | 54.5 (48 – 59.5) | 0.429 |
| Height (in cms) | 153.5 (149 – 158) | 152.5 (148 – 158) | 0.495 |
| BMI (in kg/m2) | 24.365 (22.87 – 25.175) | 24.12 (21.68 – 26.505) | 0.947 |
| Waist To Hip Ratio | 0.85 (0.82 – 0.865) | 0.845 (0.82 – 0.85) | 0.547 |
| Systolic BP (in mm of Hg) | 120 (110 – 120) | 147 (140 – 159.5) | <0.001 |
| Diastolic BP (in mm of Hg) | 79 (70 – 80) | 100 (97 – 110) | <0.001 |
| Lymphocyte % | 8.28 (6.14 – 11.72) | 10.695 (8.57 – 13.9) | 0.159 |
| Absolute Lymphocytes (in no. of cells) | 8280 (6140 – 11720) | 10695 (8570 – 13900) | 0.159 |
| CD3+CD4+ % | 33.93 (29.67 – 36.91) | 30.26 (27.12 – 39.6) | 0.374 |
| CD4+CD25+ % | 5.17 (2.64 – 7.16) | 3.495 (1.9 – 5.8) | 0.159 |
| CD4+FOXP3+ % | 4.82 (4.22 – 5.46) | 1.615 (1.17 – 1.94) | <0.001 |
| Absolute CD3+CD4+ (in no. of cells) | 11322 (9901 – 12317) | 10097.5 (9050 – 13215) | 0.374 |
| Absolute CD4+CD25+ (in no. of cells)) | 1725 (881 – 2389) | 1166.5 (634 – 1935) | 0.159 |
| Absolute CD4+FOXP3+ (in no. of cells) | 1608 (1408 – 1822) | 539 (390 – 647) | <0.001 |
| TGF-β1 (in pg/ml) | 6229.245 (3023.31 – 6762.24) | 6445.635 (5275.9 – 6666.03) | 0.718 |
| IL-6 (in pg/ml) | 12.405 (9.95 – 15.8) | 35.195 (22.37 – 49.92) | <0.001 |
| hsCRP (in mg/ml) | 3.245 (2.205 – 5.06) | 6.965 (3.355 – 28.675) | 0.011 |

A Flow diagram illustrating the workflow of the study

Figure 1.
Reference range determination, the normal reference ranges of the studied parameters.
Table 2.
Lower and Upper Limit of Reference Range by Robust Method with 90%CI.
| Parameter | Lower Limit (90% CI) | Upper Limit (90% CI) | Overall Reference Range |
|---|---|---|---|
| CD3+CD4+ (no. of cells) | 6758.95 (6097 – 6097) | 14109.7 (13805 – 14359) | 6758.95 – 14109.7 |
| CD4+CD25+ (no. of cells) | 486.8 (467 – 467) | 3809.7 (3637 – 3951) | 486.8 – 3809.7 |
| CD4+FOXP3+ (no. of cells) | 964.15 (934 – 934) | 2005.65 (1949 – 2052) | 964.15 – 2005.65 |
| TGF-β1 (pg/ml) | 2290.35875 (2234.76 – 2234.76) | 7619.36325 (6843.45 – 8321.38) | 2290.35875 – 7619.36325 |
| IL-6 (pg/ml) | 7.82 (7.82 – 7.82) | 50.12775 (46.29 – 53.6) | 7.82 – 50.12775 |
| hsCRP (mg/ml) | 0.47125 (0.02 – 0.02) | 7.845 (7.32 – 8.32) | 0.47125 – 7.845 |

Figure 2.
ROC Curve analysis for evaluation of diagnostic efficacy of the studied parameters.
Table 3.
Area Under Curve analysis of the studied parameters.
| Test Result Variable(s) | AUC (95% CI) | p-value |
|---|---|---|
| Absolute CD3+CD4+ Count | 0.588 (0.434 – 0.792) | 0.378 |
| Absolute CD4+CD25+ Count | 0.637 (0.437 – 0.781) | 0.142 |
| Absolute CD4+FOXP3+ Count | 0.982 (0.950 – 1.0) | <0.001 |
| TGF-β1 (pg/ml) | 0.391 (0.211 – 0.220) | 0.931 |
| IL-6 (pg/ml) | 0.863 (0.743 – 0.982) | <0.001 |
| FOXP3 Count + IL-6 | 0.994 (0.982 – 1.008) | <0.001 |
Table 4.
Threshold value of the studied immunological parameters.
| Parameter | Cut-Off Value | Sensitivity | Specificity |
|---|---|---|---|
| Absolute CD3+CD4+ count | ≤10305 | 61.11 | 75.00 |
| Absolute CD4+CD25+ count | ≤1184 | 55.56 | 67.86 |
| Absolute CD4+FOXP3+ count | ≤1098 | 100.00 | 89.29 |
| TGF-β1 (pg/ml) | >4175.33 | 85.00 | 53.33 |
| IL-6 (pg/ml) | >18.66 | 85.00 | 76.67 |
| hsCRP (mg/ml) | >3.01 | 80.00 | 66.67 |