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NCT03616730 · ClinicalTrials.gov registry record
NICOM in Pregnant Women With Heart Disease
A clinical trial, sponsored by Saint Luke's Health System.
- Terminated
- Registry status
- 100
- Enrollment target
NCT03616730 is a clinical trial that was terminated before completion, run by Saint Luke's Health System. The registered enrollment target is 100 participants.
The verdict
NCT03616730 was terminated before completion, sponsored by Saint Luke's Health System.
- TERMINATED
- Registry status
- 100 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST NICOM (non-invasive cardiac output monitor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2022-08-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03616730
The ClinicalTrials.gov registry entry for NCT03616730 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Saint Luke's Health System, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NICOM (non-invasive cardiac output monitor) is the first listed.
NCT03616730 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03616730 about?
NCT03616730 is a clinical study titled "NICOM in Pregnant Women With Heart Disease". 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. Clin...
What is the current status of trial NCT03616730?
This trial is currently terminated. The enrollment target is 100 participants. The study started on 2018-10-17. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT03616730?
The interventions under investigation include: NICOM (non-invasive cardiac output monitor) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03616730?
This trial is sponsored by Saint Luke's Health System, which has 26 total clinical trials registered on ClinicalTrials.gov.
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