title: Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial.
abstract: It is common practice in many centers to offer antithrombotic medications to women with unexplained recurrent miscarriage, in the presence or absence of inherited thrombophilia. Although no benefit of aspirin vs placebo has been clearly demonstrated, a double-blind placebo-controlled trial on the effect of low-molecular-weight heparin is lacking. We enrolled 258 pregnant women with a history of unexplained recurrent miscarriage (≥2 consecutive miscarriages before 15 weeks' gestation) and a negative thrombophilia workup. They were randomly assigned to receive one daily subcutaneous injection of enoxaparin 40 mg or placebo until 35 weeks' gestation. We included 256 women (mean age 32 years, ≥3 miscarriages: 72%; mean gestational age 39 days of amenorrhea) in the intention-to-treat analysis; 66.6% of 138 who received enoxaparin had a live birth vs 72.9% of 118 who received placebo. The absolute difference was -6% (95% CI, -17.1 to 5.1), excluding a 10% increase in the rate of live-birth on enoxaparin (P = .34). In this first randomized, double-blind, placebo-controlled trial, enoxaparin (40 mg once daily) did not improve the chance of a live birth in nonthrombophilic women with unexplained recurrent miscarriage. This trial is registered at www.ClinicalTrials.gov as #NCT00740545 and the French National Health and Drug Safety Agency (EudraCT #2006-003350-18).
authors: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Department of Internal Medicine and Chest Diseases, Brest University Hospital, La Cavale Blanche Hospital, Brest, France;
authors: Elisabeth
authors: http://orcid.org/0000-0002-5849-0204
authors: E
authors: Pasquier
authors: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Department of Internal Medicine and Chest Diseases, Brest University Hospital, La Cavale Blanche Hospital, Brest, France;
authors: Luc
authors: L
authors: de Saint Martin
authors: Division of Gynaecology, François Mitterand Hospital, Pau, France;
authors: Caroline
authors: C
authors: Bohec
authors: Division of Gynaecology, Saint Etienne University Hospital, Saint Etienne, France;
authors: Céline
authors: C
authors: Chauleur
authors: Division of Gynaecology, Université de la Méditerranée, Hôpital Nord, Marseille, France;
authors: Florence
authors: F
authors: Bretelle
authors: Centres d'Investigation Clinique-INSERM 1412, La Cavale Blanche Hospital, Brest, France;
authors: Gisèle
authors: G
authors: Marhic
authors: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Centres d'Investigation Clinique-INSERM 1412, La Cavale Blanche Hospital, Brest, France;
authors: Grégoire
authors: G
authors: Le Gal
authors: Division of Gynaecology, Lille University Hospital, Lille, France;
authors: Véronique
authors: V
authors: Debarge
authors: Division of Internal Medicine, Bretagne Sud Hospital, Lorient, France;
authors: Frédéric
authors: F
authors: Lecomte
authors: Division of Gynaecology, Caen University Hospital, Clemenceau Hospital, Caen, France;
authors: Christine
authors: C
authors: Denoual-Ziad
authors: Division of Gynaecology, Paris University Hospital, Necker Hospital, Paris, France;
authors: Véronique
authors: V
authors: Lejeune-Saada
authors: Division of Gynaecology, Dijon University Hospital, Complexe du Bocage, Dijon, France; and.
authors: Serge
authors: S
authors: Douvier
authors: Division of Gynaecology, Groupe Hospitalier du Sud de la Réunion, Saint Pierre, France.
authors: Michel
authors: M
authors: Heisert
authors: EA 3878 Groupe d'Etude de la Thrombose de Bretagne Occidentale, Centres d'Investigation Clinique-INSERM 1412, La Cavale Blanche Hospital, Brest, France;
authors: Dominique
authors: D
authors: Mottier
mesh_terms: D000026:Abortion, Habitual / Q000517:prevention & control*; D000328:Adult; D000925:Anticoagulants; D004311:Double-Blind Method; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005865:Gestational Age; D006495:Heparin, Low-Molecular-Weight; D006801:Humans; D050498:Live Birth; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control*; D011379:Prognosis
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006495:Heparin, Low-Molecular-Weight
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