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Fasilitator :
Dr. Abram Siregar Sp.OGBy :
Yafet Yanri Sirupang (04-136)
Fasilitator :
Dr. Abram Siregar Sp.OGBy :
Yafet Yanri Sirupang (04-136)
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Approximately 1% of all women
trying to conceive
Defined as 3 previous miscarriages
when recurrent miscarriage is defined as 2
previous miscarriages, the proportion rises to 5%.
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Which would improve theWhich would improve the
livelive--birth rate among women withbirth rate among women withunexplainedunexplained
recurrent miscarriage in thisrecurrent miscarriage in thisstudy??study??
Aspirin combined withAspirin combined with
lowlow--molecularmolecular--weight heparinweight heparin
Aspirin aloneAspirin alone
Compared with placeboCompared with placebo
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Study Population
Evaluated patients at 3 universityhospitals and 5 teaching hospitals in theNetherlands, February 2004 - January
2008. Women 18 - 42 years unexplained
recurrent miscarriage , attempting toconceive, or pregnant with a gestationalage 6 weeks.
Previous miscarriage pregnancy lossat a gestational age of 20 weeks.
Recurrent miscarriage 2miscarriages (ACOG)
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Study Design and Treatment Regimen
Aspirin in the form ofcalcium carbasalate
100 mg daily dose
equivalent to 80 mg
of acetylsalicylicacid
Aspirin or placebo- started at the time of
randomization
- continued 36
weeks GA- stopped
miscarriage, adiagnosis of ectopicpregnancy, orpremature delivery.
LMWH in the formof nadroparin
subcutaneously at adaily dose of 2850IU
Initiated when aviable intrauterinepregnancy wasconfirmed on USG,- starting at 6 weeks of
gestation,- continued throughoutpregnancy
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Outcome Measures The primary outcome : live births.
Secondary outcomes :
- miscarriage,
- IUFD (fetal death after 20 weeks of gestation),
- and obstetrical complications such :1. preeclampsia,
2. the HELLP syndrome (hemolysis, elevatedliver enzymes, and a low platelet count),
3. IUGR (birth weight below the 10th percentile
for gestational age and sex),4. placental abruption, and
5. premature delivery.
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Combination
AspirinOnly
Plasebo
121
120
123
A total of 364 women
were enrolled, with
-123 the combinationtherapy group,
-120 the aspirin only group
-121 to the placebo
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becamepregnant(299)
Nopregnant(65)
L
ivebirth(65.9%)
No LiveBirth(34.1%)
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In analyses involving women who
became pregnant, live-birth rates also
did not different significantly among the
three groups, with rates of- 69.1% in the combination-therapy
group,
- 61.6% in the aspirin-only group, and
- 6 .0% in the placebo group
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Increased tendency significantly more common
the combination-therapy group
PlaceboombinationTherapy
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Neither aspirin combined with heparin(nadroparin ) or aspirin alone improved thechance of a live birth in women with a historyof unexplained recurrent miscarriage.
Live-birth rates were 54.5% in thecombination therapy group, 50.8% in theaspirin-only group, and 5 .0% in the placebogroup. Among women who becamepregnant, these rates were69.1%, 61.6%, and 6 .0%, respectively.
Side effects, most notably an increasedtendency to bruise and swelling or itching atthe injection site, occurred in almost half thewomen in the combination therapy group.
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The hypothesis that women with
unexplained recurrent miscarriagemight benefit from aspirin, heparin, orboth was based on a presumption thatthis condition might be caused bythrombosis in decidual vessels.
Likewise, we found no significantbenefits in other subgroups, including
women with inherited thrombophilia(who might be most likely to benefitfrom treatment with heparin or aspirin
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In conclusion, our findings do not
support the hypothesis that either
combination therapy with aspirin
and Heparin (nadroparin) or aspirinalone improves the chance of a
live birth for women with
unexplained recurrent miscarriage.
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