Table 2.
Randomized controlled trials (RCTs) on prenatal management of FNAIT.
| Author (publication year) | Number of research subjects | ICH in sibling, n (%) | FBS, n (%) | IUPT, n (%) | FBS/IUPT related adverse event, n (%) | IVIg/steroids related side effects, n (%) | ICH, n (%) | Neonatal PLTs (×103/μL) | Conclusions |
|---|---|---|---|---|---|---|---|---|---|
| Bussel JB, et al. (1996) (132) | IVIg 1 g/kg/wk: n=28 | 6 (21.4) | All | 0 | 5 (17.9) | 0 | 0 | 96 | IVIg is suitable for severe thrombocytopenia in FNAIT cases, and dexamethasone does not increase the effect of IVIg. |
| IVIg 1 g/kg/wk + dexamethasone: n=26 | 4 (15.4) | All | 0 | – | 2 (7.7) | 0 | 110.1 | ||
| Berkowitz RL, et al. (2006) (131) | High risk: IVIg 1 g/kg/wk: n=21 | 4 (19.0) | All | 0 | 11 (13.9) | – | 3 (3.8) | 66.8 | FBS may significantly increase fetal mortality rate. |
| High risk: IVIg 1 g/kg/wk + prednisone 1 mg/kg/d: n=19 | 3 (15.8) | All | 0 | – | 99.4 | ||||
| Standard risk: IVIg 1 g/kg/wk: n=19 | 0 | All | 0 | – | 33 (84.6) > 50 | ||||
| Standard risk: prednisone 1 mg/kg/d: n=20 | 0 | All | 0 | – | |||||
| Berkowitz RL. et al. (2007) (116) | IVIg 2 g/kg/wk: n=37 | 0 | All | 0 | 2 (5.4) | 12 (32.4) | 1 (2.7) | 169 | Both groups of treatments have shown good results. For pregnant women who did not give birth to infants with ICH, cordocentesis is not necessary. |
| IVIg 1 g/kg/wk + prednisone 0.5 mg/kg/d: n=36 | 0 | All | 0 | 2 (5.6) | 13 (36.1) | 1 (2.8) | 134 | ||
| Paridaans NP. et al. (2015) (115) | IVIg 0.5 g/kg/wk: n=12 | 0 | 0 | 0 | – | 0 | 0 | 81 | They recommended treating standard-risk patients with 0.5 g/kg/wk IVIg. |
| IVIg 1 g/kg/wk: n=11 | 0 | 0 | 0 | – | 0 | 0 | 110 | ||
| Kamphuis M, et al. (2016) (114) | IVIg 0.5 g/kg/wk: n=46 | 0 | 0 | 0 | 0 | – | 0 | 112 | For FNAIT pregnant women who did not give birth to ICH neonates, 0.5 or 1 g/kg/wk IVIg has a similar therapeutic effect. |
| IVIg 1 g/kg/wk: n=63 | 0 | 0 | 0 | – | 0 | 119 |
ICH, intracranial hemorrhage; FBS, fetal blood sampling; IUPT, intrauterine platelet transfusion; IVIg, intravenous immunoglobulin; “-”, not known or not applicable.