Table 1. Summary of the reported papers on CA15-3 levels during normal and pathological pregnancies.
| Authors/year of publication | Pathological conditions of pregnancy | Sample | Number of patients | Cut-off value (U/mL) | Results |
|---|---|---|---|---|---|
| Touitou et al, 1989 [11] | None | MS | - 100 healthy pregnant women - 22 healthy non-pregnant volunteers |
<25 | Major increase during the third trimester; none above cut-off value. |
| Lelle et al, 1989 [25] | Pre-eclampsia | UC, MS and AF | 134 pregnant women at 7–43 weeks of gestation (3/134: twin pregnancies; 5/134 pre-eclampsia) | £25 | 9.4% of CA 15-3 values were above the cut-off during gestation. Not detectable in UC. Low in AF with a range of 2–18 U/mL. |
| Schrocksnadel et al, 1993 [10] | Gestational hypertension | MS | - 50 patients with gestation hypertension - 50 healthy pregnant patients - 50 healthy non-pregnant controls |
£25 | CA 15-3 lower in non-pregnant controls (median < 5 U/L) than in healthy pregnant women (median 21 U/L) (p < 0.0001), but similar in healthy and hypertensive pregnant women (median 18 U/L) (p = 0.34) |
| Noci et al, 1995 [22] | Down’s syndrome |
AF | - 20 single Down’s syndrome pregnancies at 15–19 weeks - 60 controls |
NR | The median MoM values of CA 15-3 in Down’s syndrome pregnancies were 1.16 MoM, not significantly different from those of unaffected pregnancies (CA 15.3: 0.99 MoM). |
| Schlageter et al, 1998 [12] |
None | MS | 12 healthy pregnant women at 6–40 weeks of amenorrhoea | £30 | Linear temporal evolution of CA1 5-3 but with concentrations in the usual range of values. |
| Tayyar et al, 1999 [17] | None | AF and MS | 62 pregnant women at 16–20 weeks of gestation |
NR | MS CA 15-3 values were elevated in the primigravida group. |
| Cheli et al, 1999 [13] | None | MS | 90 healthy pregnant women during the three trimesters of pregnancy | NR | CA 15-3 values were above the cut-off (3.3%) and were significantly elevated in the third trimester as compared to the first trimester of pregnancy (p < 0.05). |
| Botsis et al, 1999 [16] | None | AF and MS | - T1 = 20; - T2 = 29; - T3 = 26; - at parturition = 20; - controls: 20 healthy, age-matched, non-pregnant women |
£33 | CA 15-3 values in AF, which were marginally higher than in MS, did not differ significantly with the progression of pregnancy. 5%, 10% and 20% above cut-off value, in the three trimesters, respectively. |
| Bon et al, 2001 [18] | Spontaneous abortion, foetal death, intrauterine growth retardation, chromosomal abnormalities, (pre)-eclampsia and structural abnormalities | MS | - 350 normal pregnancies (T1 = 127, T2 = 192, T3 = 47) - 120 pathological pregnancies (spontaneous abortion = 8, foetal death = 8, intrauterine growth retardation = 46, chromosomal abnormalities = 12, (pre)-eclampsia = 6 and structural abnormalities = 42) |
NR | MS CA 15-3 levels in normal pregnancies were significantly higher during the third trimester compared to the first two trimesters of pregnancy. Serum CA15-3 levels in the serum of pregnant women with a pathological outcome were not significantly different from those found in normal pregnancy. |
| Hegab et al, 2003 [20] | Complete hydatidiform mole |
MS | - 60 cases of complete hydatidiform mole - Controls: 20 therapeutic abortion of a corresponding duration of pregnancy |
NR | No significant statistical difference was found between all groups. |
| Kiran et al, 2005 [14] | No | UC and MS | 53 pregnant women just before caesarean delivery of full-termed pregnancies (38–42 weeks) |
£30 | MS levels of CA 15-3 are not influenced by pregnancy. UC CA 15-3 levels were significantly lower than MS levels at term pregnancies. |
| Ercan et al, 2011 [15] | No | MS | 30 healthy pregnant women | £25 | It was found that the three trimesters had statistically similar levels for serum CA 15-3 (median values 17.5, 19.7 and 18.3 U/mL, respectively). CA 15-3 assay values were found generally within the normal range. Fourteen patients’ CA 15-3 values were elevated above the cut-off value of 25 U/mL (16%) during each trimester: T1 = 5; T2 = 5; T3 = 4. |
| Akinlade et al, 2012 [21] | Trisomy 21 | MS | - 69 trisomy 21 - 388 euploid controls |
NR | Not affected by gestational age. No evidence of a significant difference in CA 15–3 concentrations among trisomy 21 and control pregnancies (1.03 MoM in euploid, 1.09 in trisomy 21, p = 0.130) |
| Sharma et al, 2015 [19] | Gestational diabetes, preexisting heart disease, intrahepatic cholestasis of pregnancy, thyroid disorder, anaemia, coagulation disorder, hypertensive disorder, epilepsy |
MS | - 31 non-pregnant women - 251 pregnant women: 77/251 (30.7%) with high risk pregnancies: gestational diabetes = 20 (26.0%) preexisting heart disease = 16 (20.8%) intrahepatic cholestasis of pregnancy 13 (16.9%) thyroid disorder = 11 (14.3%) (9 hypothyroidism and 2 hyperthyroidism) anaemia = 11 (14.3%) coagulation disorder = 9 (3.6%) hypertensive disorder = 9 (3.6%) epilepsy = 3 (3.9%) |
£30 | Among the pregnant women, 93 (37.1%) had a CA 15-3 value above the normal cut-off. CA 15-3 concentration was significantly higher in the second and third trimesters than in the first trimester (p ≤ 0.01 for both comparisons). CA 15-3 level was also increased in pregnancies associated with gestational diabetes mellitus, intrahepatic cholestasis of pregnancy and heart disease. |
NR, not reported; MS, maternal serum; AF, amniotic fluid; UC, umbilical cord; T1, first trimester; T2, second trimester; T3, third trimester