Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy

Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe) Clinical Trial

— ICASH  

Official title:

Impedance Cardiographic Assessment of Gravidas With Severe Hypertension (ICASH)to Assess Impact of Standard Therapy on Hemodynamic Parameters - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248169
• Other study ID #: 2007-0187
• Status: Completed
• Phase: N/A
• First received: November 23, 2010
• Last updated: December 11, 2013
• Start date: December 2009
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparous or parous patients with severe hypertension

• Singleton gestation

• Gestational age greater than 20 weeks

Exclusion Criteria:

• Multiple gestation

• Gestational age less than 20 weeks

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Albuminuria
• Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe)
• Eclampsia
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)
• Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia)
• Proteinuria

Locations

Country	Name	City	State
United States	Wiser Hospital for Women and Infants at the University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usefulness of Impedance Cardiography (ICG) in pregnant women with hypertension	ICG test is performed on pregnant women before receiving any antihypertensive medication. Labetalol and Hydralazine, two ot the most commonly used antihypertensives to treat high blood pressure in pregnant women will be used in this study.	36	No