Aspirin and Nadroparin No Better Than Placebo Among Women With History of Unexplained Miscarriage: Presented at ASH
By Ed Susman
NEW ORLEANS, LA -- December 6, 2009 -- The common practice of treating women with a history of unexplained miscarriages with an anti-coagulation strategy appears to work no better than placebo in allowing these women to deliver a live child, researchers said here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition.
Doctors in the Netherlands recruited 364 women into the trial in which aspirin 100 mg alone was tried in 1 arm of the study; aspirin combined with nadroparin 2,850 IU, a low-molecular-weight heparin was used in a second arm; and a third group of patients received placebo.
“About 1% to 3% of women have recurrent miscarriage, and about 50% of the reasons for those miscarriages are unexplained,” said Stef Kaandorp, MD, University of Amsterdam, Amsterdam, Netherlands. “Because many of these women are desperate to have children, their physicians will often ‘do something’ and that includes offering anticoagulation therapy.”
Dr. Kaandorp explained: “There is a presumed aetiologic similarity between unexplained recurrent miscarriage and antiphospholipid syndrome. In women with recurrent miscarriage and antiphospholipid syndrome, treatment with heparin and aspirin appears to improve pregnancy outcome.”
However, with the results of his trial in hand, Dr. Kaandorp said, “it now would not be proper for doctors to prescribe aspirin or low-molecular-weight heparin to these women.”
In a press briefing, he said:
· Of the 97 women in the low-molecular-weight heparin group who became pregnant, 67 delivered a healthy child, a live birth rate of 69.1%.
· Of the 99 women in the aspirin group who became pregnant, 61 delivered a healthy child, a live birth rate of 61.1%.
· Of the 103 women in the placebo group who became pregnant, 69 delivered a healthy child, a live birth rate of 67.0%.
In none of the scenarios was there any statistically significant difference, Dr. Kaandorp said.
The treatment didn’t come without some cost in side effects, said senior study author Saskia Middeldorp, MD, University of Leiden, Leiden, Netherlands. “Half the women on anti-coagulant therapy reported bruising, and 40% of the women treated with low-molecular-weight heparin reported injection site pain and reactions,” she said.
Dr. Kaandorp said his trial indicated “these treatments should not be recommended. Aspirin and nadroparin and aspirin alone do not improve the chance of a live birth in women with unexplained recurrent miscarriage.”
The trial did not receive industry funding.
[Presentation title: Aspirin and Aspirin Combined with Low-Molecular-Weight Heparin in Women With Unexplained Recurrent Miscarriage: A Randomized Controlled Multicenter Trial (ALIFE Study). Abstract 488]
|
