Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial

Pasquier, Elisabeth; Martin, Luc de Saint; Bohec, Caroline; Chauleur, Céline; Bretelle, Florence; Marhic, Gisèle; Gal, Grégoire Le; Debarge, V.; Lecomte, F; Denoual-Ziad, C.; Lejeune-Saada, V.; Douvier, S.; Heisert, Michel; Mottier, Dominique

doi:10.1182/blood-2014-11-610857

Cited by 104 publications

(105 citation statements)

References 35 publications

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“…Some trials suggest benefit in reducing recurrent early and late pregnancy loss,13 14 as well as reduction in adverse outcomes and placental vasculopathy 15 16. Conversely, a recent double-blinded randomised controlled study by Pasquier et al 17 reported, in keeping with similarly well conducted studies, that LMWH did not improve live birth rates in non-thrombophilic women with previous consecutive recurrent miscarriage 18–20…”

Section: Discussionmentioning

confidence: 97%

Successful pregnancy following treatment of recurrent chronic histiocytic intervillositis

Vardi

Paterson²,

Hung

2017

BMJ Case Reports

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Chronic histiocytic intervillositis (CHI) is a rare placental lesion associated with adverse obstetric outcomes and high recurrence rate. We report a case of six consecutive pregnancies in one woman, where CHI was detected following an intrauterine death in the fifth pregnancy, after being missed in four earlier losses. The successful sixth pregnancy was treated with a combination of immunosuppressive and antithrombotic agents. While low-molecular-weight heparin (LMWH) and aspirin had been shown to improve pregnancy outcome in recurrent pregnancy loss, there was limited evidence of improved outcome in CHI. It has been suggested that CHI may result from a maternal immunological process and there have been a few reports of the use of corticosteroids because of this possibility, though without convincing evidence of efficacy. We too tried a corticosteroid, in combination with LMWH and aspirin. Comparative histopathological analysis of the placentae supported post-treatment effectiveness of our intervention strategy.

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Section: Discussionmentioning

confidence: 97%

Successful pregnancy following treatment of recurrent chronic histiocytic intervillositis

Vardi

Paterson²,

Hung

2017

BMJ Case Reports

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“…Our results are similar to those in studies reported in the literature. In a similar study, Pasquier et al [14] enrolled 258 pregnant women with a history of unexplained recurrent miscarriage (≥2 consecutive miscarriages before 15 weeks' gestation) and a negative thrombophilia screen. They were randomly assigned to receive one daily subcutaneous injection of 40 mg enoxaparin or placebo until 35 weeks' gestation.…”

Section: Discussionmentioning

confidence: 99%

“…They concluded that enoxaparin (40 mg once daily) did not improve the chance of a live birth in nonthrombophilic women with unexplained RPL. [14] In another similar multicentre, randomised controlled trial, Schleussner et al [15] determined whether LMWH increases live birth rates in women with unexplained RPL. They enrolled 449 women, with at least 2 early or 1 late miscarriages, at 5 -8 weeks' gestation after confirmation of a viable pregnancy by ultrasonography.…”

Section: Discussionmentioning

confidence: 99%

Preventive role of low-molecular-weight heparin in unexplained recurrent pregnancy loss

et al. 2017

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RESEARCHBackground. Recurrent pregnancy loss (RPL) is a source of great distress for couples, and the search continues for an intervention to improve live birth rates in affected women. A daily injection of low-molecular-weight heparin (LMWH) is often prescribed to women with unexplained RPL, although evidence suggesting a benefit is limited. Objective. To compare the efficacy of LMWH with a placebo in terms of live birth rates in women with unexplained RPL. Methods. All pregnant females between 18 and 44 years of age who reported at the unit of obstetrics and gynaecology, Shifa International Hospital, Islamabad, during April 2013 to January 2014, who had a history of ≥2 consecutive first trimester pregnancy losses were enrolled. All participants were randomly allocated to one of two groups. Group A received a daily dose of 40 mg enoxaparin (LMWH) subcutaneously and group B women received a placebo in the form of multivitamin tablets. Efficacy was defined in terms of live births after the age of viability (i.e. 24 weeks' gestation) and was compared in both treatment and control groups. Risk estimation was also performed and relative risk (RR) along with 95% confidence interval (CI) was calculated. Results. The groups were similar in terms of mean age, gestational age and body mass index. Our results showed no statistically significant difference in live birth rates between the two groups, with 78.8% and 73.8% for group A and B, respectively (p=0.0574). A RR of 1.07 (95% CI 0.9 -1.3) was calculated for group A. Conclusion. Subcutaneous enoxaparin in a once daily dose of 40 mg did not improve the chance of live births in nonthrombophilic women with unexplained RPL when compared with the placebo. Recurrent pregnancy loss (RPL) is one of the commonly encountered complications in reproductive medicine, as the aetiology is often unknown and there are few evidence-based diagnostic and treatment strategies available. There are varying definitions of RPL reported that include ≥2 failed clinical pregnancies as documented by ultrasonography or histopathological examination; [1] or 3 consecutive pregnancy losses, which are not required to be intrauterine. [2] The definition of RPL also includes non-visualised pregnancy losses (biochemical pregnancy losses and/or pregnancies of unknown location) as they have the same negative impact on future live birth rate as intrauterine pregnancy losses. [3] The European Society of Human Reproduction and Embryology released a 2014 consensus statement proposing that RPL describes repeated pregnancy loss regardless of anatomic location. They did not recommend the number of losses required for the problem to be defined as recurrent. However, the statement advised researchers and clinicians to clearly describe the type of pregnancy loss, gestational age, number of prior pregnancy losses and relevant details of ultrasound measurements. [4] There is a consensus that healthy women should not undergo extensive evaluation after a single first trimester or early second trimester spontaneous miscar...

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“…In fact, its prescription has been increasing more and more since the mid-90s and has been shown to be safe for both mother and foetus, in spite of the passage through placenta. In women suffering from early pregnancy loss, it has been shown to be not efficacious [69][70][71][72]. The EAGer doubleblind, placebo-controlled randomised controlled trial (RCT) recently suggested that also preconception-initiated low-dose aspirin did not significantly improve the likelihood of delivering a live born child in 1078 women with one to two previous pregnancy losses.…”

Section: Interventions In Gvcsmentioning

confidence: 99%

Aspirin and heparin in pregnancy

Villani

Tiscia

2015

Expert Opinion on Pharmacotherapy

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Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial

Cited by 104 publications

References 35 publications

Successful pregnancy following treatment of recurrent chronic histiocytic intervillositis

Successful pregnancy following treatment of recurrent chronic histiocytic intervillositis

Preventive role of low-molecular-weight heparin in unexplained recurrent pregnancy loss

Aspirin and heparin in pregnancy

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