Researchers testing immunotherapy for couples suffering from recurrent miscarriages
Research Update: This trial is no longer ongoing at the University of Chicago Medicine.
December 9, 2004
Researchers from the University of Chicago are recruiting couples for a study to determine if intravenous immunoglobulin (IVIG), an immune system booster, helps couples that have experienced recurrent miscarriages for unexplained reasons after having one successful pregnancy.
Six medical centers in the United States and Canada are participating in the study. The University of Chicago researchers are seeking about 60 couples for their trial, which is supported by the National Institutes of Health Clinical Research Center and is approved by the FDA.
"Analyses of four preliminary studies using IVIG are encouraging in terms of its ability to improve live birth rates in couples that miscarry repeatedly for unexplained reasons," said study director Mary Stephenson, MD, MSc, professor of obstetrics and gynecology at the University of Chicago. "This study was designed to determine definitively whether IVIG is effective in improving the live birth rate in couples that suffer from secondary recurrent miscarriage."
IVIG is an expensive drug made of antibodies produced by white blood cells to fend off bacteria, viruses and other foreign bodies. It is used to treat several immune disorders, including multiple sclerosis, lupus, rheumatoid arthritis and other connective tissue diseases. It may suppress a mother's adverse immunological responses to pregnancy that could result in miscarriages.
The immunoglobulins are collected from donated blood, which is commercially purified and treated. It's administered intravenously in the hospital setting.
Women who participate in the trial should be from 18 to 44 years old and have had one successful live birth followed by at least three unexplained consecutive miscarriages, all with the same partner. Genetic, endocrine, anatomical and autoimmune factors should have been ruled out as reasons for their previous miscarriages.
The study is randomized and double-blinded, which means the women will be given by chance either IVIG or salt water (placebo). Neither the women nor the researchers know who received the drug or the placebo until after the study is completed. A woman may re-enter and receive the alternate infusion if she has another unexplained miscarriage in the study. This compassionate component of the study will ensure that if the woman did not receive IVIG with the initial pregnancy, she will in the subsequent one.
Recurrent miscarriages are a common complication of pregnancy. An estimated 15 to 20 percent of all pregnancies result in miscarriage. About 1 percent of couples experience recurrent miscarriage, defined as three or more consecutive pregnancy losses that occurred before five months of pregnancy.
The causes for recurrent miscarriages vary. About 50 percent of the losses are unexplained, meaning genetic and hormonal causes, uterine and cervical structural abnormalities have been ruled out. An immunological cause has been suggested for more than 80 percent of unexplained recurrent miscarriages.
"By evaluating the use of this drug, we will gain a better understanding of a pregnant woman's immune response to pregnancy," Dr. Stephenson said. "Recurrent miscarriages are emotionally draining and frustrating for couples. We want to know if using IVIG is truly effective and can help some of these couples."
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