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.