ALIFE: Aspirin with, without nadroparin did not improve live birth rate
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51st ASH Annual Meeting
The live birth rate did not improve for women with unexplained recurrent miscarriage when treated with aspirin alone or in combination with nadroparin, a low-molecular-weight heparin.
One percent to three percent of women of reproductive age have recurrent miscarriages. The condition is unexplained in 50% of women involved with this problem, according to information presented by Stef P. Kaandorp, MD, during a press conference at the 51st ASH Annual Meeting. Kaandorp is a research fellow in the department of obstetrics and gynecology at the Academic Medical Center, Amsterdam.
Researchers from the Netherlands conducted a multicenter, randomized trial examining data from 364 women aged 18 to 42 years who were attempting to conceive or were less than six weeks pregnant. Participants previously had two or more unexplained miscarriages by week-20 of pregnancy.
Participants were randomly assigned to aspirin (Ascal; Vemedia BV; n=120), aspirin plus nadroparin (n=123) or placebo (n=121) once a day through 36 weeks of gestational age, or until miscarriage, ectopic pregnancy or premature delivery. Nadroparin was started as soon as a viable intra-uterine pregnancy was diagnosed at approximately 6 weeks gestational age and used until delivery started.
In the intention-to-treat analysis the live birth rate was similar among treatment groups. Live birth occurred in 50.8% of those in the aspirin group, 54.5% of those in the aspirin combined with nadroparin group and 57% of those in the placebo group.
“The study clearly demonstrates that aspirin combined with heparin and aspirin alone do not prevent (recurrent, unexplained) a future miscarriage and that we should not needlessly put these women through the inconvenience and risks associated with these blood-thinning medications,” Kaandorp said in a press release.
“These results are extremely important because they will likely change the way some women at high risk for another miscarriage have been treated,” he said. - by Christen Haigh
For more information:
- Kaandorp S. #488. Presented at: 51st ASH Annual Meeting and Exposition; Dec. 4-8, 2009; New Orleans.
Women with a history of two or more unexplained pregnancy losses before gestational age 20 weeks were enrolled and randomly assigned to aspirin, aspirin together with prophylactic dose of a low-molecular-weight heparin (LMWH) or placebo. The live birth rate in the three groups did not differ.
The study findings indicate that treatment with aspirin or aspirin plus LMWH is not useful in unselected women with two or more unexplained pregnancy losses. However, subgroup analysis and future studies will need to determine whether there are groups of women, who might derive benefit from antithrombotic therapy, such as women who have a thrombophilia, or women with recurrent losses at a certain time of their pregnancy, for example after week 10.
- Stephan Moll, MD
Associate Professor,
Division of Hematology-Oncology, UNC School of Medicine, Chapel Hill