ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01248169
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : December 12, 2013
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center

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.

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

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 Type : Observational
Actual Enrollment : 30 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Hydralazine

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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 Posted: November 25, 2010    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

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