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

Completed

• Conditions: Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia); Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe); Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)

• Registration Number: NCT01248169
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usefulness of Impedance Cardiography (ICG) in pregnant women with hypertension	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.

Trial Locations

Locations (1)

Wiser Hospital for Women and Infants at the University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States