PREVENTION OF UNEXPLAINED RECURRENT SPONTANEOUS-ABORTION USING INTRAVENOUS IMMUNOGLOBULIN - A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL

PROBLEM: The efficacy of intravenous immunoglobulin (IVIG) for treatme nt of unexplained recurrent spontaneous abortion was assessed in a pro spective, randomized, double-blinded, and placebo-controlled study. ME THOD OF STUDY: The study took place in a provincial recurrent pregnanc y loss clinic, located in a tertiary/quaternary care academic center. The study subjects were women with a history of two or more documented consecutive spontaneous pregnancy losses under 20 weeks of gestation, excluding any associated with aneuploidy by karyotype analysis, and w ith no evidence of genetic, endocrine, infectious, anatomic, or autoim mune factors associated with a history of recurrent spontaneous aborti on. The subjects were randomized to receive either intravenous immunog lobulin (Gamimune N) as treatment or normal saline as placebo. Randomi zation was stratified for primary, secondary, and unclassified unexpla ined recurrent spontaneous abortion. Success was defined as an ongoing pregnancy beyond 20 weeks of gestation. RESULTS: Sixty-two subjects e nrolled in the trial. There were 37 index pregnancies and 6 cross-over pregnancies. There was no clinically significant difference between t he treatment arm and the placebo arm in terms of subsequent pregnancy success. There seemed to be a higher success rate with the stratified analysis of couples with secondary unexplained recurrent spontaneous a bortion, but the trial did not have sufficient power to confirm this. CONCLUSIONS: Based on this trial and three similar trials in the liter ature, a multicentered trial is needed to determine conclusively wheth er IVIG is effective in the treatment of unexplained recurrent spontan eous abortion.