|Participants||1969 women were randomised from January 1983 to June 1984.|
Setting: women were recruited from 23 maternity units in the Paris region, France.
Inclusion criteria: women who were primipara and were Rh-negative.
Exclusion criteria: none detailed.
|Interventions||Treatment group (Anti-D) (n = 927)|
Women received two anti-D immunoglobulin injections (100 micrograms by intramuscular injection (500 IU)) at 28 and 34 weeks of pregnancy, after blood samples had been taken.
Control group (no Anti-D) (n = 955)
No placebo was given.
In both groups, women who gave birth to a Rhesus positive baby were administered post-partum (intravenously in almost all cases) anti-D immunoglobulin (100 micrograms), with possible re-treatment following review of fetal red blood cell test results.
1450 women were primigravid and 432 were multigravid.
|Outcomes||Incidence of immunisation during pregnancy, immunisation at 2-12 months following pregnancy, positive Kleihauer during pregnancy, at delivery, or postpartum. Cost-effectiveness data also provided.|
|Notes||From the translation received for this manuscript, 1969 women began the study, with 1882 monitored until they went into labour.|
The blood groups ABO and Rhesus D were determined using standard techniques.
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||High risk||Not detailed - women were allocated to groups on the basis of their birth year (even/odd)|
|Allocation concealment (selection bias)||High risk||As above.|
|Blinding of participants and personnel (performance bias) |
|Unclear risk||Blinding was not detailed, however considered unlikely in view of the intervention. The lack of blinding, however, may be considered unlikely to affect the objectively measured outcomes.|
|Blinding of outcome assessment (detection bias) |
|Unclear risk||As above.|
|Incomplete outcome data (attrition bias) |
|High risk||From the translation received - 1969 women began the study, of those 1882 were monitored until they were in labour (the 87 women not followed up to birth were not accounted for).|
In the control group, 2/957 women were excluded due to fetal-maternal haemorrhage, leaving 955 who were monitored until labour. Of these women, 590/955 gave birth to a Rh-positive baby, however two died at birth; 468 women were followed up postpartum (no reasons given for the 122 women not followed up postpartum). In the treatment group 599/927 gave birth to a Rh-positive baby; 472 women were followed up postpartum (no reasons given for the 127 women not followed up postpartum).
|Selective reporting (reporting bias)||Low risk||No clear evidence of selective reporting - outcome measures reported appear to have been pre-specified.|
|Other bias||Low risk||No obvious risk of other bias.|