Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265415
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-11
Brief Title:
Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
A Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine to Control Blood Pressure in Severe Pre-eclampsia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
Pre-eclampsia PE is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe formcontrol of blood pressure is of crucial importance to avoid maternal and fetal complicationsTherapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
Detailed Description:
Pre-eclampsia PE is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form
Pre-eclampsia characterized by
Rising blood pressure BP 14090 that occurs after 20 weeks of gestation in a woman with previously normal BP
Proteinuria 300mg24hr This correlates with 30mgdl or 1 on urine dipstick
Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications
The pathophysiology of pre-eclampsia is most likely inadequate placentation leading to endothelial dysfunction and reduced nitric oxide bioavailability Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
Nitroglycerine a nitric oxide donor with low oral bioavailability and a very short half-life has a potent venodilator effect in low doses and affects arterial tone at high doses Labetalol is useful as it contains both selective competitive alpha1-adrenergic antagonism and non-selective competitive beta-adrenergic B1 and B2 blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker Its main uses are as an antianginal and antihypertensive
Pre-eclampsia characterized by
Rising blood pressure BP 14090 that occurs after 20 weeks of gestation in a woman with previously normal BP
Proteinuria 300mg24hr This correlates with 30mgdl or 1 on urine dipstick
Edema control of blood pressure is of crucial importance to avoid maternal and fetal complications
The pathophysiology of pre-eclampsia is most likely inadequate placentation leading to endothelial dysfunction and reduced nitric oxide bioavailability Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE
Nitroglycerine a nitric oxide donor with low oral bioavailability and a very short half-life has a potent venodilator effect in low doses and affects arterial tone at high doses Labetalol is useful as it contains both selective competitive alpha1-adrenergic antagonism and non-selective competitive beta-adrenergic B1 and B2 blocking activity in a single agent Nifedipine is a dihydropyridine calcium channel blocker Its main uses are as an antianginal and antihypertensive
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