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CompletedNCT01248169ICASHUpdated Dec 12, 2013

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

An observational study in Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia), Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe) and Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia), sponsored by University of Mississippi Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-12-12.

Sponsored by University of Mississippi Medical Center · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy; Proteinuria, With Hypertension (Severe Pre-eclampsia)
  • Delivery; Proteinuria, With Gestational Hypertension (Pre-eclampsia, Severe)
  • Pregnancy; Hypertension, Gestational Hypertension, With Albuminuria (Severe Pre-eclampsia)
03

In context

Eclampsia

328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.

This study's enrollment of 30 is below the median of 158 across 146 observational studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

University of Mississippi Medical Center is the lead sponsor of 125 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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.

Inclusion criteria

  • Nulliparous or parous patients with severe hypertension
  • Singleton gestation
  • Gestational age greater than 20 weeks

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation
  • Gestational age less than 20 weeks
05

Study design

Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36

07

Study locations

1 site
  • Wiser Hospital for Women and Infants at the University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01248169
Lead sponsor
University of Mississippi Medical Center
Responsible party
James Martin (Professor, Ob-Gyn, University of Mississippi Medical Center) — Principal investigator
First posted
Nov 25, 2010
Start date
Dec 2009
Primary completion
Jul 2013
Completion
Nov 2013
Last update
Dec 12, 2013

Study contacts

James N Martin, MD
principal investigator · SOM-Obstetrics & Gynecology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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