Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history – an open-label randomised trial (the EPPI trial): study protocol

It is widely accepted that thrombophilia in pregnancy greatly increases the risk of venous thromboembolism. Pregnancy complications arise, at least partly, from placental insufficiency. Any change in the functioning of the gestational transient biological system, such as inherited or acquired thrombophilia, might lead to placental insufficiency. In this research we included 64 pregnant women with trombophilia and 70 cases non-trombophilic pregnant women, with or without PMPC, over a two-year period. The purpose of this multicenter case-control study is to analyze the maternal-fetal management options in obstetric thrombophilia, the impact of this pathology on the placental structure and possible correlations with placenta-mediated pregnancy complications. Maternal-fetal management in obstetric thrombophilia means preconceptional or early diagnosis, prevention of pregnancy morbidity, specific therapy as quickly as possible and fetal systematic surveilance to identify the possible occurrence of placenta-mediated pregnancy complications.

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“…LMWH has been proposed as a potential preventive therapy for a number of PMPC including preeclampsia and IUGR [14].…”

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confidence: 99%

Maternal-Fetal Management in Trombophilia Related and Placenta-Mediated Pregnancy Complications

Berceanu¹,

Ciurea²,

Cîrstoiu³

et al. 2018

Rev. Chim.

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“…The criteria of PE included new-onset hypertension (at least 140 mmHg and/or 90 mmHg) after 20 weeks of gestation associated with proteinuria (≥300 mg/24 h), or, in the absence of this, thrombocytopenia (platelet count < 100 × 10 9 /L), renal insufficiency (serum creatinine concentration > 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal diseases), impaired liver function, pulmonary edema, and brain or visual symptoms. PE subtypes were defined according to ISSHP [21]: patients with pre-eclampsia with severe features presenting blood pressure > 160 mmHg systolic or 110 mmHg diastolic; early-onset pre-eclampsia patients with the onset of symptoms occurring before 34 weeks of pregnancy; preterm pre-eclampsia occurring between 34 +1 and 37 +0 weeks of pregnancy; and intrauterine growth restriction (IUGR) defined as an estimated fetal weight below the 10th percentile for gestational age [22]. GH was defined as new-onset hypertension (at least 140 mmHg and/or 90 mmHg) after 20 weeks of gestation without proteinuria and/or the aforementioned symptoms of end-organ damage [1].…”

Section: Subjectsmentioning

confidence: 99%

Plasma eNOS Concentration in Healthy Pregnancy and in Hypertensive Disorders of Pregnancy: Evidence of Reduced Concentrations in Pre-Eclampsia from Two Independent Studies

Kaihara,

Minami,

Peraçoli

et al. 2023

Diseases

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Hypertensive disorders of pregnancy (HDP), comprising gestational hypertension (GH) and pre-eclampsia (PE), are leading causes of maternal and perinatal morbidity and mortality. Both GH and PE are characterized by new-onset hypertension, but PE additionally includes proteinuria and/or end-organ damage. Impaired nitric oxide (NO) bioavailability may lead to endothelial dysfunction in GH and PE, and the primary source of vascular NO is endothelial NO synthase (eNOS). However, no previous study has investigated plasma eNOS concentrations in patients with GH and PE. In this study, we compared plasma eNOS concentrations in healthy pregnancies and HDP in two independent cohorts. The primary study included 417 subjects, with 43 non-pregnant (NP) and 156 healthy pregnant (HP) women and 122 patients with GH and 96 with PE. The replication study included 85 pregnant women (41 healthy and 44 pre-eclamptic). Plasma concentrations of eNOS were measured using a commercial ELISA kit provided by R&D Systems, and plasma nitrite concentrations were assessed using two ozone-based chemiluminescence assays. Correlations between plasma eNOS concentrations and plasma nitrite concentrations, as well as clinical and biochemical parameters, were evaluated by either Spearman’s or Pearson’s tests. In the primary study, NP women and HDP had significantly lower plasma eNOS concentrations compared to HP; concentrations were even lower in PE compared to GH. Plasma eNOS concentrations were reduced but not significant in early-onset PE, PE with severe features, preterm birth, and intrauterine growth restriction. No correlation was observed between plasma eNOS and nitrite levels. In HDP, there was a significant positive correlation between levels of eNOS and hemoglobin (r = 0.1496, p = 0.0336) as well as newborn weight (r = 0.1487, p = 0.0316). Conversely, a negative correlation between eNOS levels and proteinuria was observed (r = −0.2167, p = 0.0179). The replication study confirmed significantly reduced plasma concentrations of eNOS in PE compared to HP. Our findings provide evidence of reduced plasma eNOS concentrations in HDP; they were particularly lower in PE compared to GH and HP in two independent studies.

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“…Similarly, Hoorn et al, 5 reported that combined LMWH and Aspirin treatment did not show a decrease in onset of frequent hypertensive disorders in patients with anti-phospholipid antibodies. Likewise, Groom et al, 6 also reported no additional benefit for adding Enoxaparin in preventing pre-eclampsia and IUGR.…”

Section: Introductionmentioning

confidence: 97%

Pre-Eclampsia and Intrauterine Growth Restriction (IUGR)Prevention– Is Enoxaparin an Effective Option

Saeed

Barkat

Murtaza

2022

PAFMJ

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Objective: To determine the effectiveness of Enoxaparin in preventing pre-eclampsia and intrauterine growth restriction in women with the history of pre-eclampsia and IUGR in an earlier pregnancy. Study Design: Quasi-Experimental Study. Place and Duration of Study: Department of Obstetrics and Gynaecology, Pak Emirates Military Hospital, Rawalpindi Pakistan, from Mar to Sep 2019. Methodology: In this study, a total of 186 pregnant females of age 20-40 years with >6 ± 0 and <16 ± 0 weeks gestation were included. They were divided into two groups. In the study group, injection Enoxaparin 40 mg s/c OD was started from 6 weeks to 36 weeks of gestation along with Aspirin 75 mg OD. In the control group, only Aspirin 75mg OD was given. An antenatal check-up was performed, and patients were followed for liquor volume, fetal growth and doppler ultrasound. Study outcomes were noted in terms of pre-eclampsia and intrauterine growth restriction. Results: The majority of the patients 100 (53.76%), were between 20-30 years of age. The mean gravidity in the study group was 3.84 ± 1.20 and in the control group was 3.83 ± 1.22. In this study, pre-eclampsia was found in 6 (6.45%) patients in the Enoxaparin group and in 17 (18.28%) patients of control group (p-value 0.014). Intrauterine growth restriction was observed in 9 (9.68%) patients of Enoxaparin group and in 28 (30.11%) patients of control group (p-value 0.001). Conclusion: This study concluded that Enoxaparin effectively prevents pre-eclampsia and intrauterine growth restriction in patients with a previous history....

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Enoxaparin for the prevention of preeclampsia and intrauterine growth restriction in women with a prior history – an open-label randomised trial (the EPPI trial): study protocol

Cited by 6 publications

References 48 publications

Maternal-Fetal Management in Trombophilia Related and Placenta-Mediated Pregnancy Complications

Maternal-Fetal Management in Trombophilia Related and Placenta-Mediated Pregnancy Complications

Plasma eNOS Concentration in Healthy Pregnancy and in Hypertensive Disorders of Pregnancy: Evidence of Reduced Concentrations in Pre-Eclampsia from Two Independent Studies

Pre-Eclampsia and Intrauterine Growth Restriction (IUGR)Prevention– Is Enoxaparin an Effective Option

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