C B Coulam1. 1. Reproductive Immunology, Genetics and IVF Institute, Fairfax, VA 22031.
Abstract
PROBLEM: Recurrent spontaneous abortion (RSA) is the cause of childlessness in 2-5% of reproducing couples. Immunological mechanisms have been proposed as an etiology in some cases of RSA. Various forms of immunotherapy have been attempted in individuals thought to have an immunologic mechanism associated with RSA. Intravenous immunoglobulin (IVIG) has been used in a pilot study to successfully treat women with RSA. METHOD: To evaluate the efficacy of IVIG in the prevention of RSA as prospective randomized, placebo-controlled clinical trial was undertaken. Women experiencing two or more consecutive RSAs receive eitherIVIG 500 mg/kg/month or placebo (albumin). RESULTS: To date 92 women have been enrolled in the study and 58 pregnancies have been achieved. The outcome of the 58 pregnancies include 20 deliveries, 9 ongoing pregnancies and 29 losses. Fourteen (49%) of the 29 pregnancy losses were blighted ova (empty gestational sacs) and 15 (51%) were intrauterine fetal deaths (IUFD's) occurring in the first trimester of pregnancy. Of 14 blighted ova, 8 were in women receiving IVIG and 6 were receiving placebo. Fifteen IUFD's occurred: 3 (20%) in women receiving IVIG and 12 (80%) placebo. Of 11 pregnancy losses occurring in women receiving IVIG, 8 (73%) were blighted ova and 3 (27%) were IUFD's. Eighteen losses occurred in women receiving placebo: 6 (33%) were blighted ova and 12 (67%) were IUFD's. CONCLUSIONS: These preliminary data suggest IVIG may be effective treatment for RSA. Analysis of data from the completed randomized placebo-controlled trial will test this suggestion.
RCT Entities:
PROBLEM: Recurrent spontaneous abortion (RSA) is the cause of childlessness in 2-5% of reproducing couples. Immunological mechanisms have been proposed as an etiology in some cases of RSA. Various forms of immunotherapy have been attempted in individuals thought to have an immunologic mechanism associated with RSA. Intravenous immunoglobulin (IVIG) has been used in a pilot study to successfully treat women with RSA. METHOD: To evaluate the efficacy of IVIG in the prevention of RSA as prospective randomized, placebo-controlled clinical trial was undertaken. Women experiencing two or more consecutive RSAs receive either IVIG 500 mg/kg/month or placebo (albumin). RESULTS: To date 92 women have been enrolled in the study and 58 pregnancies have been achieved. The outcome of the 58 pregnancies include 20 deliveries, 9 ongoing pregnancies and 29 losses. Fourteen (49%) of the 29 pregnancy losses were blighted ova (empty gestational sacs) and 15 (51%) were intrauterine fetal deaths (IUFD's) occurring in the first trimester of pregnancy. Of 14 blighted ova, 8 were in women receiving IVIG and 6 were receiving placebo. Fifteen IUFD's occurred: 3 (20%) in women receiving IVIG and 12 (80%) placebo. Of 11 pregnancy losses occurring in women receiving IVIG, 8 (73%) were blighted ova and 3 (27%) were IUFD's. Eighteen losses occurred in women receiving placebo: 6 (33%) were blighted ova and 12 (67%) were IUFD's. CONCLUSIONS: These preliminary data suggest IVIG may be effective treatment for RSA. Analysis of data from the completed randomized placebo-controlled trial will test this suggestion.