NICOM in Pregnant Women With Heart Disease

NCT03616730 | Terminated FDA Device

• 1 other identifier: 18-062
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An accepted "gold standard" for hemodynamic monitoring in women with both healthy and diseased hearts is not currently available. Pregnancy is associated with significant hemodynamic changes, both during and following delivery, which can be even more profound in the structurally-abnormal heart. Clinical management of these women is based on surrogate markers of cardiac indices such as peripheral blood pressure, heart rate and oxygen saturation, rather than the use of invasive testing due to its associated complications. Echocardiography has largely replaced PAC in the obstetric population to measure cardiac output due to its non-invasive nature and good correlation with PAC18. However, its use is limited in the intrapartum period due to the need for clinical expertise in obtaining and interpreting the images. The proposed study has the potential to validate bio-reactance cardiac output monitoring using the NICOM against echocardiography for use in structurally normal and abnormal pregnant hearts in order to better drive goal-directed (specifically delivery mode) therapy through continuous hemodynamic monitoring during the second and third stages of labor, and 24 hours postpartum.

Conditions

Heart Diseases in Pregnancy; Congenital Heart Disease in Pregnancy

Keywords

Non-invasive cardiac output monitor; Cardiac output

Outcome Measures

Primary Outcomes (1)

• Non-inferiority between NICOM and echocardiogram cardiac output measurements

  We will compare the cardiac output measurements obtained from the NICOM in each trimester with those obtained from the echocardiogram. We expect a mean percentage difference of \< 30% between modalities.

  3 year recruitment

Study Arms (2)

Heart Disease in pregnancy group

Fifty women will be recruited with structurally and functionally abnormal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Women who are unable to give informed consent will not be included.

Diagnostic Test: NICOM (non-invasive cardiac output monitor)

Control Group

Fifty women will be recruited with structurally normal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Any woman on cardiac or antihypertensive medications (beta blockers, calcium channel blockers, hydralazine) will be excluded. Women who are unable to give informed consent will not be included.

Diagnostic Test: NICOM (non-invasive cardiac output monitor)

Interventions

NICOM (non-invasive cardiac output monitor) DIAGNOSTIC_TEST

Transthoracic bio-reactance, or the non-invasive cardiac output measurement \[NICOMTM, Cheetah Medical Inc., Portland, OR\] system, is a new technique that is able to measure multiple hemodynamic parameters with four transdermal electrodes placed on the patients' thorax. It is based on frequency- and phase-modulation of the voltage signal measured in response to an applied transthoracic current. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations and is a FDA-approved device.

Control Group; Heart Disease in pregnancy group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both healthy pregnant women and pregnant women with a history of heart disease will be recruited to participate in our observational, non-inferiority trial comparing the cardiac output measurements obtained by two different modalities. Women in their first trimester will be approached to participate. Any woman with a history of either structural or acquired heart disease will be recruited into the study group as described above. Women with structurally normal hearts in the first trimester who meet the aforementioned inclusion criteria will also be recruited to participate as the control group.

You may qualify if:

• CONTROL GROUP:
• singleton pregnancy
• \> 18 years of age
• enrolled in first trimester of pregnancy
• planning delivery at Saint Luke's Hospital of Kansas City
• STUDY GROUP:
• history of either congenital or acquired heart disease
• singleton pregnancy
• \> 18 years of age
• enrolled in first trimester of pregnancy
• planning delivery at Saint Luke's Hospital of Kansas City

You may not qualify if:

• Control group:
• no history of either acquired or congenital heart disease
• no hypertension, diabetes, multiple gestations, preeclampsia, or autoimmune disease
• no use of antihypertensive medications
• inability to give informed consent
• Study Group:
• no hypertension, diabetes, multiple gestations, preeclampsia, autoimmune disease
• inability to give informed consent

Sponsors & Collaborators

• Saint Luke's Health System: lead

Study Sites (1)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (19)

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Related Links

• Up to Date article

Study Officials

• Karen L Florio, DO

  Saint Luke's Hospital of Kansas City/UMKC Assistant Professor, MFM Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 6, 2018
• Study Start: October 17, 2018
• Primary Completion: June 30, 2022
• Study Completion: August 11, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

US (1)