Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-02-08
Brief Title:
Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Intravenous Labetalol Versus Phentolamine for the Management of Severe Preeclampsia Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications All antihypertensive medication can potentially cross the placenta At this time there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another However certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy The choice of therapy depends on the acuity and severity of hypertension
Detailed Description:
Non-invasive assessment of cerebral haemodynamics using Transcranial doppler ultrasonography has recently gained importance Essentially TCD measures flow velocity in the insonated vessel and the changes in flow velocity can be taken to reflect the changes in blood flow assuming that the diameter of the insonated vessel remains constant As TCD is easy to use and gives reproducible measurements it has become a widely accepted method of assessing the cerebrovascular reactivity to carbon dioxide CRCO2 cerebral autoregulation estimated CPP and CrCP In patients with neurological disorders impairment in both cerebral autoregulation and cerebral vascular reactivity has been shown to predict poor neurological outcome Knowledge of the effects of normal pregnancy and pre-eclampsia on cerebral haemodynamics is essential for appropriate management of these patients undergoing anaesthesia or in labour particularly when vasoactive medications are administered The effects of pregnancy andor pre-eclampsia on MCAFV have been studied by other investigators Ikeda and colleagues found little change in mean MCAFV during the first two trimesters but reduced values in the third trimester Williams and Wilson showed that MCAFV fell significantly with advancing gestational age In another study Williams and Wilson used TCD to assess cerebral haemodynamics in 17 non-pregnant women 17 normotensive pregnant women 20 pregnant women with pre-existing hypertension and 21 pre-eclamptic women The pregnant women were all in their third trimester There was no difference in mean MCAFV in healthy pregnancy compared with non-pregnant women and a small but non-significant increase in mean MCAFV in the hypertensive and pre-eclamptic women Demarin and colleagues studied pre-eclamptic women before and after delivery and found a progressive increase in MCAFV during late pregnancy Ohno and colleagues compared MCAFV in 35 healthy pregnant and 17 pre-eclamptic women In this study the mean MCAFV was significantly higher in the pre-eclamptic group It has been suggested that these increases in MCAFV are because of a degree of vasospasm The differences between the findings of various studies with regards to the changes in MCAFV in pre-eclampsia might be explained by the differences in the severity of pre-eclampsia between the studies Some investigators have reported increased MCAFV in symptomatic compared with asymptomatic pre-eclamptics
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