Fig 1.
PRISMA flow diagram illustrating the selection procedure.
Table 1.
Baseline characteristics of the included trials.
Baseline characteristics of the included trials according to IVIg regimen, placebo participants and types of miscarriage.
Table 2.
Risk of bias in the included trials.
Risk of bias in the included trials according to a series of domains. In relation to these assessment of these domains the trials were classified as high or low overall risk of bias.
Fig 2.
Meta-analysis for the outcome no live birth for all trials (A) and Trial sequential analysis for the outcome no live birth for all trials (B).
A) Forest Plot of the meta-analysis for the outcome no live birth, B) The diversity-adjusted required information size (DARIS) of 1,008 patients was calculated on the basis of type I error of 5%, type II error of 20%, the control group event proportion (PC) of 43%, a relative risk reduction (RRR) of 20%, and the diversity (D2) 0% of the meta-analysis. The cumulative Z-curve does not cross the trial sequential monitoring boundaries for benefits, harms, or futility, and the required information size was not reached.
Table 3.
Data sources for the subgroup analyses of the outcome ´no live birth`.
Data sources for the subgroup analyses in relation to aggregate published data, individual patient data (IPD) from a trial where the randomisation was stratified according to this factor and IPD from a trial where the randomisation was not stratified according to this factor.
Fig 3.
Meta-analysis for the subgroup analysis for women with primary RM compared to secondary RM (A) and Trial sequential analysis for women with secondary RM (B).
A) Forest Plot for the outcome no live birth, B) The diversity-adjusted required information size (DARIS) of 698 patients was calculated on the basis of type I error of 5%, type II error of 20%, the control group event proportion (PC) of 53%, a relative risk reduction (RRR) of 20%, and the diversity (D2) 0% of the meta-analysis. The cumulative Z-curve does not cross trial sequential monitoring boundaries for benefits, harms, or futility, and the required information size was not reached.