Aspirina asociada o no a heparina, sin efecto sobre aborto recurrente

El manejo de la paciente con aborto habitual sigue siendo controversial. En un estudio holandés publicado esta semana en el NEJM, se randomizaron 364 pacientes a placebo, aspirina 80 mg o aspirina 80 mg + heparina. El estudio mostró que las 3 modalidades terminaron con RN vivos en rangos entre el 50 y 57%, sin diferencias significativas.

ABSTRACT

Background Aspirin and low-molecular-weight heparin are
prescribed for women with unexplained recurrent miscarriage,
with the goal of improving the rate of live births, but
limited data from randomized, controlled trials are available
to support the use of these drugs.

Methods In this randomized trial,
we enrolled 364 women between the ages of 18 and 42 years who
had a history of unexplained recurrent miscarriage and were
attempting to conceive or were less than 6 weeks pregnant. We
then randomly assigned them to receive daily 80 mg of
aspirin plus open-label subcutaneous nadroparin (at a dose of
2850 IU, starting as soon as a viable pregnancy was
demonstrated), 80 mg of aspirin alone, or placebo. The
primary outcome measure was the live-birth rate. Secondary outcomes
included rates of miscarriage, obstetrical complications, and
maternal and fetal adverse events.

Results Live-birth rates did not
differ significantly among the three study groups. The
proportions of women who gave birth to a live infant were
54.5% in the group receiving aspirin plus nadroparin
(combination-therapy group), 50.8% in the aspirin-only group,
and 57.0% in the placebo group (absolute difference in live-birth
rate: combination therapy vs. placebo, –2.6 percentage
points; 95% confidence interval [CI], –15.0 to 9.9; aspirin
only vs. placebo, –6.2 percentage points; 95% CI, –18.8 to
6.4). Among 299 women who became pregnant, the live-birth
rates were 69.1% in the combination-therapy group, 61.6% in
the aspirin-only group, and 67.0% in the placebo group (absolute
difference in live-birth rate: combination therapy vs.
placebo, 2.1 percentage points; 95% CI, –10.8 to 15.0; aspirin
alone vs. placebo –5.4 percentage points; 95% CI, –18.6 to
7.8). An increased tendency to bruise and swelling or itching
at the injection site occurred significantly more frequently
in the combination-therapy group than in the other two study
groups.

Conclusions Neither aspirin
combined with nadroparin nor aspirin alone improved the
live-birth rate, as compared with placebo, among women with
unexplained recurrent miscarriage. (Current Controlled Trials
number, ISRCTN58496168 [controlled-trials.com] .)

Source Information

From the Department of Obstetrics and Gynecology (S.P.K., J.A.M.P.), the
 Center for Reproductive Medicine (M.G., F.V.), the Department of 
Clinical Epidemiology, Biostatistics, and Bioinformatics (B.A.H.), and 
the Department of Vascular Medicine (H.R.B), Academic Medical Center, 
University of Amsterdam, Amsterdam; Onze Lieve Vrouwe Gasthuis, 
Amsterdam (H.R.V.); University Hospital Maastricht, Maastricht 
University, Maastricht (K.H.); Máxima Medical Center, Veldhoven 
(B.W.M.); University Medical Center Groningen, University of Groningen, 
Groningen (N.F.); Medisch Spectrum Twente Hospital Group, Enschede 
(M.N.); Amphia Hospital, Breda (D.N.M.P.); and Leiden University Medical
 Center, University of Leiden, Leiden (S.M.) — all in the Netherlands. 
 
 
This article (10.1056/NEJMoa1000641) was 
published on March 24, 2010 at NEJM.org.

 Address reprint requests to Dr. Goddijn at the Center 
for Reproductive Medicine, H4-205, Academic Medical Center, University 
of Amsterdam, P.O. Box 22700, 1100 DE Amsterdam, the Netherlands, or at m.goddijn@amc.uva.nl.

Full
Text of this Article

ver más información de esta noticia acá › ◦ volver ›

• Imprímela
• Envíala a un Amigo
• Ver más

• Meta-análisis muestra que aspirina iniciada tempranamente reduce RCIU y preeclampsia14.08.2010
• ACOG publica nuevas guías para la prueba de parto post-cesárea14.08.2010
• Acido valproico se asocia significativamente con al menos 6 malformaciones congénitas20.07.2010
• Nuevas guias ACOG para trombofilias y embarazo20.07.2010
• Estudio sugiere mejor pronóstico cuando la histerorrafia se sutura en 2 capas28.06.2010
• Distocia de hombros es sólo una de las causas de parálisis braquial03.06.2010