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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248169
First Posted: November 25, 2010
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
  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:


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

Primary Outcome Measures:
  • Usefulness of Impedance Cardiography (ICG) in pregnant women with hypertension [ Time Frame: 36 ]
    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

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: November 2013
Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248169


Locations
United States, Mississippi
Wiser Hospital for Women and Infants at the University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: James N Martin, MD SOM-Obstetrics & Gynecology
  More Information

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
First Submitted: November 23, 2010
First Posted: November 25, 2010
Last Update Posted: December 12, 2013
Last Verified: December 2013

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