A randomized, double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage.
BACKGROUND
Previous trials of intravenous immunoglobulin (IvIg) treatment of women with recurrent miscarriage (RM) have provided diverging results. This may be due to different inclusion criteria and suboptimal treatment protocols in some trials.


METHODS
According to a computer-generated list, 58 women with at least four unexplained miscarriages were randomly assigned to receive infusions of high doses of IvIg or placebo starting as soon as the pregnancy test was positive.


RESULTS
In the intention-to-treat analysis, a 45% live birth rate was found in both allocation groups. In patients with secondary RM, 50% in the treatment group and 23% in the placebo group had successful pregnancies (P = not significant). When data from the present and a previous placebo-controlled trial of the same treatment were combined, 15/26 (58%) of the patients with secondary RM in the treatment group versus 6/26 (24%) in the placebo group had successful outcomes (P < 0.02). Only 7% of the karyotyped abortuses were abnormal.


CONCLUSIONS
IvIg may improve pregnancy outcome in patients with secondary RM. A new placebo-controlled trial focusing on this subgroup should be conducted to confirm the results.
Christiansen
Ole B
OB
Department of Clinical Immunology, Aalborg Hospital, Aalborg, Denmark. obchr@post5.tele.dk
Pedersen
Bjørn
B
Rosgaard
Anni
A
Husth
Merete
M
D000026:Abortion, Habitual / Q000453:epidemiology / Q000209:etiology / Q000235:genetics / Q000517:prevention & control*; D000328:Adult; D001723:Birth Rate; D004311:Double-Blind Method; D005260:Female; D005333:Fetus / Q000502:physiology; D005500:Follow-Up Studies; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007621:Karyotyping; D008297:Male; D010919:Placebos; D011247:Pregnancy; D012744:Sex Ratio
D016756:Immunoglobulins, Intravenous; D010919:Placebos