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临床试验/NCT06312852
NCT06312852尚未招募不适用

Antenatal Steroids Before Elective Caesarean Section : Impact on Coagulation, Fibrinolytic System, and Other Haematological Parameters.

Assiut University0 个研究点目标入组 45 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
Antenatal corticosteroids impact on Coagulopathy

研究概览

简要总结

Aim of the research :

1- Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers.

详细描述

Corticosteroid administration before anticipated preterm birth is one of the most important antenatal therapies available to improve newborn outcomes. A single course of corticosteroids is recommended for pregnant women between 28 weeks and 40 weeks of gestation who are at risk of preterm delivery within 7 days, including for those with ruptured membranes and multiple gestations (1). The administration of antenatal corticosteroids to women who, at risk of imminent preterm birth, is strongly associated with decreased neonatal morbidity and mortality (2). Neonates whose mothers received antenatal corticosteroids have significantly lower severity, frequency, or both, of respiratory distress syndrome, intracranial haemorrhage, necrotizing enterocolitis, and death, compared with neonates whose mothers did not receive antenatal corticosteroids, Betamethasone and dexamethasone are the most widely studied corticosteroids, and they generally have been preferred for antenatal treatment to accelerate foetal organ maturation (3). Both cross the placenta in their active form and have nearly identical biologic activity. Both lack mineralocorticoid activity and have relatively weak immunosuppressive activity with short-term use (4).

Increased levels of haemostatic factors, including factor VII, factor VIII, factor XI, fibrinogen, soluble CD40 ligand, and von Willebrand Factor VWF have been associated with venous and arterial thrombotic events. Similarly, impaired thrombolysis, reflected by an increase in Plasminogen activator inhibitor-1 PAI-1 levels, has been associated with adverse cardiovascular events. Although there are no previous in vivo studies in humans demonstrating that glucocorticoids directly affect haemostasis, there is in vitro and epidemiologic evidence of this phenomenon (5). In cultured human and animal cell lines, glucocorticoids increase production of von Willebrand Factor (VWF), endothelin, and PAI-1. Two studies have demonstrated dexamethasone-mediated increases in PAI-1 in cultured human adipose tissue. In patients with Cushing syndrome, elevated levels of VWF, PAI-1, thrombin-antithrombin and plasmin-antiplasmin complexes and factor VIII may resolve after curative surgical treatment. Similarly, altered levels of haemostatic factors have been reported in patients receiving exogenous glucocorticoids. The potential impact of glucocorticoids on thrombosis is clinically relevant (6). Therefore, we sought to determine the effects of antenatal glucocorticoid administration on haemostatic factors in pregnant females.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with gestational age between 28-40 weeks ( third trimester ) who will be offered antenatal steroids versus gestational-age matched controls who will not be on steroids.

排除标准

  • Pregnant women with gestational age < 28 weeks (First trimester & Second trimester).
  • Women in labour.
  • Pregnant women receiving blood transfusions or on any drugs that might counteract the effect of Antenatal corticosteroids, or any drug that may have an effect on coagulation or fibrinolysis.

结局指标

主要结局

Antenatal corticosteroids impact on Coagulopathy

时间窗: Baseline

Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers.

次要结局

  • Follow up for cases on corticosteroid therapy(Day 4)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Ahmed Mohamed Aly Ahmed Nasr

Resident of Clinical pathology department, Faculty of Medicine, Assiut University, Egypt

Assiut University

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