Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT01248169
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2010-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy
Sponsor:
University of Mississippi Medical Center
Organization:
Study Overview
Official Title:
Impedance Cardiographic Assessment of Gravidas With Severe Hypertension (ICASH)to Assess Impact of Standard Therapy on Hemodynamic Parameters - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-12
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:
ICASH
Brief Summary:
The utilization of external cardiohemodynamic patient assessment, applying non-invasive stick-on contact patches to the mother's neck on either side and chest wall on either side, enables the practitioner to have information about the patient's cardiac function and vascular status beyond simply blood pressure and pulse. This information, once collected, should open the practitioner's eyes to better assess the patient's disease status and her response to therapy. We will use this information to compare the effectiveness of the two standard medications used for treatment of maternal high blood pressure.
Detailed Description:
Pregnant patients with severe acute hypertension due either to superimposed preeclampsia, severe preeclampsia or severe gestational hypertension will be randomized to receive either of two antihypertensive agents (hydralazine or labetalol). Just before drug administration and immediately thereafter impedance cardiography of the patient will be undertaken and the results analyzed relative to the cardiac profile and the drug administered to reduce the severe hypertension.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: