Enoxaparin prevents stillbirth in pregnant women with clotting disorder

04/30/04

(WASHINGTON, April 30, 2004) Enoxaparin, an anticoagulant, has proven to be an effective preventive measure against stillbirth in pregnant women with hereditary thrombophilia, according to a new study published in the May 15, 2004, issue of Blood, the official journal of the American Society of Hematology.

Thrombophilia, a tendency for excessive blood clotting, increases the risk of stillbirth because it interrupts the normal circulation of blood from the mother to the placenta. A team of researchers from two French institutions, the University Hospital in Nimes and the University of Montpellier 1, studied 160 pregnant women with genetic risk factors for thrombophilia (heterozygous factor V Leiden mutation, prothrombin G20210A mutation, or protein S deficiency) who had experienced one unexplained stillbirth at 10 weeks gestation or later prior to the study.

Treatment for the women began in their eighth week of the new pregnancy. Eighty participants were provided with 40 mg of enoxaparin by subcutaneous injection each day. Because of ethical concerns regarding providing pregnant women with a placebo, the researchers instead provided the other 80 participants with low-dose aspirin (100 mg daily), a commonly used blood thinner. All participants were also given 5 mg of folic acid a day as an additional preventive measure, beginning at least one month prior to conception and continuing throughout the pregnancy.

The results of enoxaparin use were impressive. Of the women on the drug, 86 percent had a normal live birth. In addition, no significant side effects were seen in these mothers or their newborns. The group taking aspirin suffered 57 pregnancy losses and only 29 percent of the women taking this medication had a successful birth.

The enoxaparin babies also weighed more than those born to the mothers taking aspirin; only 10 percent of enoxaparin newborns were small for their gestational age, compared with 30 percent of the aspirin newborns. Low birth weight is associated with a greater risk of severe health problems, such as coronary heart disease and developmental disability.

According to Jean-Christophe Gris, M.D., Ph.D., of the University Hospital and lead author of the study, "For women with a prior pregnancy loss and a genetic predisposition to thrombophilia, treatment with enoxaparin is associated with a much greater chance of live birth and a normal-weight baby, without adverse side effects."

"The studies reported by Dr. Gris and colleagues from Nimes and Montpelier are the first to provide evidence that therapy using the anticoagulant enoxaparin significantly reduces the pregnancy loss rate associated with genetic thrombophilia compared with women treated with low-dose aspirin," said Kenneth G. Mann, Ph.D., Professor and Chairman of the Department of Biochemistry at the University of Vermont. "Although additional randomized clinical trials are needed before recommending enoxaparin therapy for the routine management of pregnant women with these specific thrombophilia disorders, the compelling results of this study and the relatively benign nature of the therapy support the potential of a wider application in treating individuals with recurrent fetal losses due to genetic thrombophilias."

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