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

Study Overview
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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.

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

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)

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hydralazine<br>This group will receive administration of the antihypertensive Hydralazine for the attempted control of their blood pressure and stabilization of their hemodynamic state. | |
| Labetalol<br>This group will receive administration of the antihypertensive Labetalol for the attempted control of their blood pressure and stabilization of their hemodynamic state. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |