Relationship between Thrombophilic Disorders and Type of Severe Early-Onset Hypertensive Disorder of Pregnancy

Ganzevoort, Wessel; Rep, Annelies; Vries, J.I. de; Bonsel, Gouke J.; Wolf, Hans

doi:10.1080/10641950701521601

Cited by 20 publications

(7 citation statements)

References 53 publications

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“…Sample size In all, 128 subjects were needed to detect a 50% reduction from a 35% recurrence rate of HD [1] (one‐tailed, power 80%). Two‐tailed calculations (sample size 262) were initially used, although not considered strictly necessary as no increase in HD and/or SGA infants was expected, nor any serious side effects of LMWH [16], and with the anticipation of sufficient recruitment, given an estimation of 1% severe HD of all pregnancies per year (180 000) in the Netherlands, 11–24% of which would have inherited thrombophilia [1,17]. The sample size was therefore recomputed using one‐sided testing.…”

mentioning

confidence: 99%

Low‐molecular‐weight heparin added to aspirin in the prevention of recurrent early‐onset pre‐eclampsia in women with inheritable thrombophilia: the FRUIT‐RCT

Vries

Pampus

Hague

et al. 2012

Journal of Thrombosis and Haemostasis

188

155

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To cite this article: de Vries JIP, van Pampus MG, Hague WM, Bezemer PD, Joosten JH and on behalf of FRUIT Investigators. Low-molecularweight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT. 2012; 10: 64-72. Summary. Background: Early-onset hypertensive disorders (HD) of pregnancy and small-for-gestational age infants (SGA) are associated with placental vascular thrombosis, these often recur and are also associated with inheritable thrombophilia. Aspirin reduces the recurrence risk. Objectives: Adding low-molecular-weight heparin (LMWH) to aspirin at < 12 weeks gestation reduces the recurrence of HD in women with previous early-onset HD (pre-eclampsia, hemolysis, elevated liver enzymes and low platelets [HELLP] syndrome and eclampsia) and/or SGA, in the context of inheritable thrombophilia without antiphospholipid antibodies. Patients/ methods: In a multicenter randomized control trial (RCT), 139 women included were < 12 weeks gestation. Inclusion criteria: previous delivery < 34 weeks gestation with HD and/or SGA; inheritable thrombophilia (protein C deficiency, protein S deficiency, activated protein C resistance, factor V Leiden heterozygosity and prothrombin gene G20210A mutation heterozygosity); and no antiphospholipid antibodies detected. Intervention: either daily LMWH (dalteparin, 5000 IU weightadjusted dosage) with aspirin 80 mg or aspirin 80 mg alone. Main outcome measures: Primary outcomes: recurrent HD onset (i) < 34 weeks gestation and (ii) irrespective of gestational age. Secondary outcomes: recurrent SGA, preterm birth, maternal/neonatal hospitalization, spontaneous abortion and individual HD. Analysis by intention-to-treat. Results: Lowmolecular-weight heparin with aspirin reduced recurrent HD onset < 34 weeks gestation (risk difference [RD] 8.7%: confidence interval [CI] of RD 1.9-15.5%; P = 0.012; number needed to treat [NNT] 12). Recurrent HD irrespective of gestational age was not different between the arms. No women withdrew as a result of adverse effects. Trial Registration: http:// www.isrctn.org) (isrctn87325378). Conclusions: Adding LMWH to aspirin at < 12 weeks gestation reduces recurrent HD onset < 34 weeks gestation in women with inheritable thrombophilia and prior delivery for HD/SGA <34 weeks. However, close monitoring of the mother and fetus remains important throughout pregnancy. J Thromb Haemost

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mentioning

confidence: 99%

Low‐molecular‐weight heparin added to aspirin in the prevention of recurrent early‐onset pre‐eclampsia in women with inheritable thrombophilia: the FRUIT‐RCT

Vries

Pampus

Hague

et al. 2012

Journal of Thrombosis and Haemostasis

188

155

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“…In 1980, Soulier and Boffa described an association between LAC and recurrent pregnancy loss (27), which was confirmed initially by case reports and later by clinical series associating aPL with (generally second‐trimester) pregnancy loss, fetal growth restriction, and severe preeclampsia (28). There is no consensus concerning which, if any, autoantibody profiles predict pregnancy outcome in women with aPL (4–14); in a recent retrospective analysis of 38 patients who were tested for LAC, aCL, and anti‐β 2 GPI it was argued that triple positivity is the best predictor (4, 5), whereas investigators from Saudi Arabia argued for (broadly defined) LAC positivity (14).…”

Section: Discussionmentioning

confidence: 91%

Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies

Lockshin

Kim

Laskin

et al. 2012

Arthritis & Rheumatism

330

249

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BACKGROUND Which serologic and clinical findings predict adverse pregnancy outcome (APO) in patients with antiphospholipid antibody (aPL) is controversial. METHODS PROMISSE is a multicenter, prospective observational study of risk factors for APO in patients with aPL (lupus anticoagulant [LAC], anticardiolipin antibody [aCL] and/or antibody to β2 glycoprotein I [anti-β2-GP-I]). We tested the hypothesis that a pattern of clinical and serological variables can identify women at highest risk for APO. RESULTS Between 2003 and 2011 we enrolled 144 pregnant patients, of whom 28 had APO. Thirty-nine percent of patients with LAC had APO, compared to 3% who did not have LAC (p < 0.0001). Only 8% of women with IgG aCL ≥40 u/mL but not LAC suffered APO, compared to 43% of those with LAC (p = 0.002). IgM aCL or IgG or IgM anti-β2-GP-I did not predict APO. In bivariate analysis, APO occurred in 52% of patients with and 13% of patients without prior thrombosis (p = 0.00005), and in 23% with SLE compared to 17% without SLE (not significant); SLE was a predictor in multivariate analysis. Prior pregnancy loss did not predict APO, nor did maternal race. Simultaneous aCL, anti-β2-GP-I, and LAC did not predict APO better than did LAC alone. CONCLUSIONS LAC is the primary predictor of APO after 12 weeks gestation in aPL-associated pregnancies. ACL and anti-β2-GP-I, if LAC is not also present, do not predict APO.

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“…Yasuda et al [11] found similar results in 22 women with IUGR without preeclampsia, while another study did not find this association in 25 women [12]. Other studies did not perform a comparative analysis [13] or were unable to do so because of a 94% incidence of IUGR in their cohort [14].…”

Section: Discussionmentioning

confidence: 93%

Associations between phenotypes of preeclampsia and thrombophilia

Berks

Duvekot

Basalan

et al. 2015

European Journal of Obstetrics & Gynecology and Reproductiv

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Relationship between Thrombophilic Disorders and Type of Severe Early-Onset Hypertensive Disorder of Pregnancy

Cited by 20 publications

References 53 publications

Low‐molecular‐weight heparin added to aspirin in the prevention of recurrent early‐onset pre‐eclampsia in women with inheritable thrombophilia: the FRUIT‐RCT

Low‐molecular‐weight heparin added to aspirin in the prevention of recurrent early‐onset pre‐eclampsia in women with inheritable thrombophilia: the FRUIT‐RCT

Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies

Associations between phenotypes of preeclampsia and thrombophilia

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