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Objective  To estimate the incidence of RhD immunisation after implementation of first trimester non-invasive fetal  RHD  screening to select only RhD negative women carrying  RHD  positive fetuses for routine antenatal anti-D prophylaxis (RAADP).    Materials and Methods  We present a population-based prospective observational cohort study with historic controls including all maternity care centres and delivery hospitals in the Stockholm region, Sweden. All RhD negative pregnant women were screened for fetal  RHD  genotype in the first trimester of pregnancy. Anti-D immunoglobulin (250–300 µg) was administered intramuscularly in gestational week 28–30 to participants with  RHD  positive fetuses. Main outcome measure was the incidence of RhD immunisation developing during or after pregnancy.    Results  During the study period 9380 RhD negative women gave birth in Stockholm. Non-invasive fetal  RHD  genotyping using cell-free fetal DNA in maternal plasma was performed in 8374 pregnancies of which 5104 (61%) were  RHD  positive and 3270 (39%)  RHD  negative. In 4590 pregnancies with an  RHD  positive test the women received antenatal anti-D prophylaxis. The incidence of RhD immunisation in the study cohort was 0.26 percent (24/9380) (95% CI 0.15–0.36%) compared to 0.46 percent (86/18546) (95% CI 0.37 to 0.56%) in the reference cohort. The risk ratio (RR) for sensitisation was 0.55 (95% CI 0.35 to 0.87) and the risk reduction was statistically significant (p = 0.009). The absolute risk difference was 0.20 percent, corresponding to a number needed to treat (NNT) of 500.    Conclusions  Using first trimester non-invasive antenatal screening for fetal  RHD  to target routine antenatal anti-D prophylaxis selectively to RhD negative women with  RHD  positive fetuses significantly reduces the incidence of new RhD immunisation. The risk reduction is comparable to that reported in studies evaluating the outcome of non selective RAADP to all RhD negative women. The cost-effectiveness of this targeted approach remains to be studied.

Targeted Routine Antenatal Anti-D Prophylaxis in the Prevention of RhD Immunisation - Outcome of a New Antenatal Screening and Prevention Program