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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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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 Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Hydralazine

This group will receive administration of the antihypertensive Hydralazine for the attempted control of their blood pressure and stabilization of their hemodynamic state.

No interventions assigned to this group

Labetalol

This group will receive administration of the antihypertensive Labetalol for the attempted control of their blood pressure and stabilization of their hemodynamic state.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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James Martin

Professor, Ob-Gyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James N Martin, MD

Role: PRINCIPAL_INVESTIGATOR

SOM-Obstetrics & Gynecology

Locations

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Wiser Hospital for Women and Infants at the University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Countries

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United States

Other Identifiers

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2007-0187

Identifier Type: -

Identifier Source: org_study_id