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

This study is currently recruiting participants.
Verified January 2013 by University of Mississippi Medical Center
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01248169
First received: November 23, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia)
Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe)
Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impedance Cardiographic Assessment of Gravidas With Severe Hypertension (ICASH)to Assess Impact of Standard Therapy on Hemodynamic Parameters - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Usefulness of Impedance Cardiography (ICG) in pregnant women with hypertension [ Time Frame: 36 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

One tube of blood


Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hydralazine
This group will receive administration of the antihypertensive Hydralazine for the attempted control of their blood pressure and stabilization of their hemodynamic state.
Labetalol
This group will receive administration of the antihypertensive Labetalol for the attempted control of their blood pressure and stabilization of their hemodynamic state.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nulliparous or parous patients with severe hypertension, a singleton gestation, gestational age greater than 20 weeks along who are admitted to the Wiser Hospital for Women and Infants at the University of Mississippi Medical Center.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248169

Locations
United States, Mississippi
Wiser Hospital for Women and Infants at the University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Sheila K Belk         sbelk@umc.edu    
Principal Investigator: James N. Martin, Jr., MD            
Sub-Investigator: Rick W. Martin, MD            
Sub-Investigator: Michelle Y. Owens, MD            
Sub-Investigator: James A. Bofill, MD            
Sub-Investigator: Birdie B. LaMarca, PhD            
Sub-Investigator: Pushpinder Dhillon, MD            
Sub-Investigator: Sara Richards, MD            
Sub-Investigator: Justin Brewer, MD            
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: James N Martin, MD SOM-Obstetrics & Gynecology
  More Information

No publications provided

Responsible Party: James Martin, Professor, Ob-Gyn, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01248169     History of Changes
Other Study ID Numbers: 2007-0187
Study First Received: November 23, 2010
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Albuminuria
Eclampsia
Hypertension
Pre-Eclampsia
Proteinuria
Hypertension, Pregnancy-Induced
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013