University of Chicago study finds therapy to prevent miscarriage is n...( e alsogiven weekly ultrasounds and 'te...),Health

e also given weekly ultrasounds and 'tender loving care' (TLC) therapy during the first 12 weeks of pregnancy. Seventy-three percent, 131 of 179 women, conceived within twelve months of immunization. Of those who became pregnant, 37 women in the treatment group had miscarriages, compared with 22 women in the control group. In addition, the immunized women had miscarriages later in pregnancy. The mean interval between conception and miscarriage was 8.9 weeks in the treatment group and 6.2 weeks in the control group, and six of the treated women had miscarriages after 10 weeks gestation.

"We began the study to determine if immunotherapy was effective in preventing recurrent miscarriage," said Carole Ober, Ph.D., "But it's surprisingly ineffective. The goal of any clinical research is to determine what treatment provides the best option for patients, and this therapy should not be used as a treatment for recurrent miscarriage."

An estimated 15-20 percent of all pregnancies result in miscarriage, making it the most common complication of pregnancy. Between 0.5-1.0 percent of couples experience recurrent miscarriage, defined as three or more fetal losses. Although there are many known factors that cause recurrent miscarriage (such as genetic and hormonal causes, uterine or cervical structural abnormalities, maternal disease and infectious causes) it is possible to identify a factor in only about 50 percent of all cases.

An independent data monitoring and safety board kept track of all data for the study. In late 1997, after all patients had been enrolled, the board asked researchers not to immunize any more patients. A few patients, who still required follow-up immunization when they did not become pregnant after six months, where not immunized a second time due to the non-beneficial results of the study.

The multicenter clinical trial was funded by a $2.2 million grant from the National Institutes of Health. Investi
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Contact: Sherri McGinnis
smcginni@mcis.bsd.uchicago.edu
773-702-6241
University of Chicago Medical Center
30-Jul-1999

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