Authors	E. Pasquier, L.S.M, C. Bohec, C. Chauleur, F. Bretelle, G. Marhic, G. L. GaL, V. Debarge, F. Lecomte, C. D. Ziad, V. L. Saada, S, Douvier, M. Heisert, D. Mottier.
Journal	Journal Blood
Year of publication	2015
Country	France
Period	From April 4th, 2007 to October 31st, 2012
Study Designer	Prospective randomized study, double-blind
Randomization	A computer performed randomization, and eligible patients were randomly assigned to one of two groups.
Inclusion criteria	Pregnant women aged 18 to 45 years and history of unexplained recurrent abortion. The current pregnancy had to be confirmed by a clinician. Recurrent spontaneous abortion was defined as ≥2 consecutive miscarriages before 15 weeks of gestation, conception with the same partner and no live births after consecutive miscarriages.
Exclusion criteria	Women with another indication for aspirin or anticoagulant therapy (e.g. increased risk of venous thromboembolism during pregnancy, chronic antithrombotic therapy for cardiovascular disease), contraindication to enoxaparin injections with 40 mg according to French labeling (e.g. anemia <10g/dL, platelet count <150 x 1012/L, creatinine clearance <30 mL / min), were either unwilling or unable to consent.
Participant demographic data	Women with an average age of 32 years (range 18-44). 72% of women had ≥ 3 previous miscarriages. The mean gestational age at randomization (i.e., the time the injections started) was 39 days of amenorrhea.
Types of interventions	Intervention group: prescribed enoxaparin 40 mg per day. Placebo group: prescribed saline solution. Enoxaparin and placebo were purchased from Sanofi-Aventis (ROVI branch for Placebo-Enoxaparin syringes, Madrid, Spain) and were packaged and labeled by the pharmacy clinical trial unit at Brest University Hospital. Enoxaparin and placebo were contained in identical syringes and packaged in identical sachets. Treatment was administered subcutaneously once daily, started from the inclusion visit (or within 24 hours) and continued by self-injection until 35 weeks of gestation. Women also received standard care and pregnancy monitoring with fetal ultrasound during the pregnancy. In addition, all were encouraged to take a folic acid supplement.
Results measures	The primary result measure was the rate of live and viable births. Secondary results were: spontaneous abortion rates, intrauterine fetal death after 20 weeks of gestation, preeclampsia, birth of a small neonate to pregnancy, placental detachment, premature birth, maternal thrombocytopenia rates (defined as platelet count <0.x basal platelet count or platelet count <100 000/mm3), bleeding episodes and skin reactions.
Results	Enoxaparin administered at a daily dose of 40 mg did not improve the chance of live birth in non-thrombophilic women with a history of unexplained recurrent miscarriage. Enoxaparin use at a daily dose of 40 mg was safe during early pregnancy.