Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312852
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
Impact of Antenatal Steroids on Coagulation
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Antenatal Steroids Before Elective Caesarean Section Impact on Coagulation Fibrinolytic System and Other Haematological Parameters
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
1- Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy fibrinolysis and other haematological markers
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None