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

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.

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Key information

Conditions

Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia) Cardiovascular Diseases Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia) Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Official study title

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

Acronym: ICASH

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Nov 25, 2010
Registry last updated: Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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