Authors |
E. Schleussner,
G. Kamin, G. Seliger, N. Rogenhofer, S. Ebner, B. Toth, M. Schenk, M. Henes,M.
K. Bohlmann, T. Fischer, O. Brosteanu,
R. Bauersach and D. Petroff |
Journal |
Annals of internal medicine |
Year of publication |
2015 |
Country |
Germany and Austria |
Period |
From December 2006 to August 2012. |
Study Designer |
Multicenter randomized controlled trial
using minimization. |
Randomization |
Randomization was stratified by
gestation week using the minimization method described by Pocock and Simon. |
Inclusion criteria |
Women with at least 2 consecutive
miscarriages (<12weeks gestation) or 1 late miscarriage (≥12 weeks
gestational age) and had a viable pregnancy during 5 to 8 weeks of pregnancy
detected by ultrasound. |
Exclusion criteria |
Women who
had previous abortions due to chromosomal alterations, uterine structural
abnormalities; women with diabetes mellitus; nicotine use, drugs, alcohol
use, HIV infection; women judged by researchers as risk of poor adherence;
women in clinical need of heparin therapy or any contraindication to LMWH;
women with Leiden factor V homozygous mutations, prothrombin homozygous
mutations, or antiphospholid antibody syndrome
(lupus anticoagulant, anti-beta2-glycoprotein 1, or anticardiolipins). |
Participant demographic data |
Women with an average age of 32.3
years. 24% of women have had at least 1 late abortion (>12 weeks
gestation) and 44% have had 3 or more miscarriages. |
Types of interventions |
Women from both groups received folic
acid containing multivitamins (Femibion 800
Metabolism [Merck]) from allocation up to 24-week gestation. The women
returned for study visits at 9, 12, 16, 20 and 24 weeks
gestation.
Intervention group: Each visit received
30 syringes each containing 5000 IU dalteparin
sodium to be self-administered daily as a subcutaneous injection
(Fragmin P
Forte [Pfizer]) up to 24 weeks of gestation.
Control group: received no placebo
injections. |
Results measures |
Primary result: ongoing pregnancy rate
up to 24 weeks gestation. Secondary results: live birth rate, preeclampsia,
placental premature detachment, preterm delivery within 37 weeks of
gestation, or intrauterine growth restriction below the 5thpercentile. |
Results |
Study data show that LMWH prescribed
for women with recurrent unexplained pregnancy loss and a viable pregnancy
does not increase live birth rates. In addition, the data show that any
effect that LMWH can have is minimal. Given the daily injection weight, we do
not recommend its use in such women with the purpose of reducing spontaneous
abortion rates. |