The Fetal Safety of Enoxaparin Use During Pregnancy: A Population-Based Retrospective Cohort Study

Shlomo, Meital; Gorodischer, Rafael; Daniel, Sharon; Wiznitzer, Arnon; Matok, Ilan; Fishman, Boris; Koren, Gideon; Levy, Amalia

doi:10.1007/s40264-017-0573-7

Cited by 12 publications

(12 citation statements)

References 22 publications

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“…The increased prevalence of adverse fetal/infant outcomes including death, prematurity and MCM have been reported following heparin use [72]. However, in another more recent study performed by Shlomol et al [28], no such associations were found within an Israeli cohort of pregnant women. While heparin does not appear to cross the placenta, it may affect embryo and fetal development through interactions with the trophoblast and placental vasculature [73].…”

Section: Discussionmentioning

confidence: 94%

“…About 20%–55% of severe COVID-19 patients have laboratory evidence of coagulopathy [ 26 ] and the use of anticoagulant therapy with heparin showed to decrease mortality [ 27 ]. Heparin in pregnancy is widely accepted and experienced in women with a high risk of thromboembolism and other conditions; in small sample size studies, heparin use during pregnancy has not shown to be putting the fetus at risk [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

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Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

et al. 2021

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Background Medications already available to treat other conditions are presently being studied in clinical trials as potential treatments for COVID-19. Given that pregnant women are excluded from these trials, we aimed to investigate their safety when used during pregnancy within a unique population source. Methods Using the population-based Quebec Pregnancy Cohort, we identified women who delivered a singleton liveborn (1998–2015). Taking potential confounders into account including indications for use, the risk of prematurity, low birth weight (LBW), small for gestational age (SGA), and major congenital malformation (MCM) associated with COVID-19 repurposed drug use during pregnancy were quantified using generalized estimation equations. Results Of the 231,075 eligible pregnancies, 107 were exposed to dexamethasone (0.05%), 31 to interferons (0.01%), 1,398 to heparins (0.60%), 24 to angiotensin-receptor blockers (ARB) (0.01%), 182 to chloroquine (0.08%), 103 to hydroxychloroquine (0.05%), 6,206 to azithromycin (2.70%), 230 to oseltamivir (0.10%), and 114 to HIV medications (0.05%). Adjusting for potential confounders, we observed an increased risk of prematurity related to dexamethasone (aOR 1.92, 95%CI 1.11–3.33; 15 exposed cases), anti-thrombotics (aOR 1.58, 95%CI 1.31–1.91; 177 exposed cases), and HIV medications (aOR 2.04, 95%CI 1.01–4.11; 20 exposed cases) use. An increased risk for LBW associated with anti-thrombotics (aOR 1.72, 95%CI 1.41–2.11; 152 exposed cases), and HIV medications (aOR 2.48, 95%CI 1.25–4.90; 21 exposed cases) use were also found. Gestational exposure to anti-thrombotics (aOR 1.20, 95%CI 1.00–1.44; 176 exposed cases), and HIV medications (aOR 2.61, 95%CI 1.51–4.51; 30 exposed cases) were associated with SGA. First-trimester dexamethasone (aOR 1.66, 95%CI 1.02–2.69; 20 exposed cases) and azithromycin (aOR 1.10, 95%CI 1.02–1.19; 747 exposed cases) exposures were associated with MCM. Conclusions Many available medications considered as treatments for COVID-19 are associated with adverse pregnancy outcomes. Caution is warranted when considering these medications during the gestational period.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

et al. 2021

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“…Enoxaparin is recommended in case of recurrent consecutive pregnancy loss [37] on the basis that this is often associated with abnormal blood clotting. There is no previous evidence of elevated malformation risk associated with enoxaparin but there is concern that the evidence base is so limited [38]. Enoxaparin does not cross the placenta and therefore is a preferred alternative to warfarin, a known teratogen, in case of pregnancy.…”

Section: Maternal Diseasementioning

confidence: 99%

Risk factors for congenital heart disease: The Baby Hearts Study, a population-based case-control study

et al. 2020

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We investigated the role of maternal environmental factors in the aetiology of congenital heart disease (CHD). A population-based case-control study (242 CHD cases, 966 controls) was conducted using an iPad questionnaire for mother with linkage to maternity and first trimester prescription records. Risk of CHD was associated with low maternal education (OR adjusted for confounders 1.59; 95% confidence interval [CI], 1.02-2.49), pregestational diabetes (OR 4.04; 95% CI 1.00-16.28), self-reported maternal clotting disorders (adjOR 8.55, 95%CI 1.51-48.44), prescriptions for the anticlotting medication enoxaparin (adjOR 3.22, 95%CI 1.01-10.22) and self-reported vaginal infections (adjOR 1.69, 95%CI 1.01-2.80). There was no strong support for the hypothesis that periconceptional folic acid supplements have a protective effect, but there was a protective effect of frequent consumption of folate rich fruits (adjOR 0.64, 95%CI 0.47-0.89). Compared to the most common pre-pregnancy dietary pattern, CHD risk was associated with a poor diet low in fruit and vegetables (adjOR 1.56, 95%CI 1.05-2.34). Mothers of cases reported more pregnancy related stress (adjOR 1.69; 95% CI 1.22-2.34) and multiple stressors (adjOR 1.94, 95%CI 0.83-4.53). We found no supportive evidence for CHD risk being associated with obesity, smoking, depression or antidepressant use in this population. Our findings add to the previous evidence base to show potential for public health approaches to help prevent CHD in future by modifying environmental factors. Independent confirmation should be sought regarding elevated CHD risk associated with maternal blood clotting disorders and their treatment, since we are the first to report this.

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“…12 However, as the available data show that overweight/obesity in pregnant women is a strong risk factor for both thromboembolism and severe COVID-19, the benefit-risk assessment is in favor of anticoagulant prophylaxis, as soon as the diagnosis of COVID-19 has been made in these patients, and it appears sound to recommend this practice. Unfractionated heparin and LMWH do not cross the placenta, are safe for the fetus, 13 and LMWH is the drug of choice for the prevention and treatment of venous TE during pregnancy because of its practical advantages over heparin and unfractionated heparin, lower risk of side effects, and safety profile. 13 In critically ill pregnant patients, a caesarean section (with its bleeding risk) may be indicated at any time if the maternal condition worsens.…”

Section: Both the International Subcommittee For Women's Health Issues In Thrombosis And Haemostasis (Isth) And The American Society Ofmentioning

confidence: 99%

“…Unfractionated heparin and LMWH do not cross the placenta, are safe for the fetus, 13 and LMWH is the drug of choice for the prevention and treatment of venous TE during pregnancy because of its practical advantages over heparin and unfractionated heparin, lower risk of side effects, and safety profile. 13 In critically ill pregnant patients, a caesarean section (with its bleeding risk) may be indicated at any time if the maternal condition worsens. Thus, each patient deserves individualized assessment of her specific risk profile, justifying that the management is multidisciplinary and the dose of anticoagulants be adjusted on a case-by-case basis.…”

Section: Both the International Subcommittee For Women's Health Issues In Thrombosis And Haemostasis (Isth) And The American Society Ofmentioning

confidence: 99%

COVID‐19, Virchow's triad and thromboembolic risk in obese pregnant women

Carbillon

Fermaut

Benbara

et al. 2021

Clinical Cardiology

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The Fetal Safety of Enoxaparin Use During Pregnancy: A Population-Based Retrospective Cohort Study

Abstract: Exposure to enoxaparin during pregnancy was not associated with an increased risk of major malformations in general or according to organ systems. Nonetheless, risk for specific malformations cannot be ruled out.

Cited by 12 publications

References 22 publications

Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy

Risk factors for congenital heart disease: The Baby Hearts Study, a population-based case-control study

COVID‐19, Virchow's triad and thromboembolic risk in obese pregnant women

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