Heart Diseases in PregnancyNCT03616730
NICOM in Pregnant Women With Heart Disease
An observational study of Heart Diseases in Pregnancy and Congenital Heart Disease in Pregnancy, run by Saint Luke's Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases in Pregnancy, Congenital Heart Disease in Pregnancy
- What is being tested?
- NICOM (non-invasive cardiac output monitor)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 11 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
Official title: Validation of a Non-invasive Cardiac Output Monitor (NICOM) in Pregnant Women With Structural 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. 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.
Read the detailed description
Major hormonal and hemodynamic changes occur in the cardiovascular system in pregnancy that can unmask and impact underlying cardiac disease. Cardiac output can rise by up to 50% throughout gestation, with an additional 30% rise intrapartum. This increase is multifactorial, owing to an increase of 50% in maternal blood volume during pregnancy, a decrease in afterload due to a decline in systemic vascular resistance and a rise in the maternal heart rate of up to 20 beats per minute. Cardiac output has been the most extensively studied physiologic parameter of cardiac performance during pregnancy, and is dependent on both heart rate and stroke volume. Most of the changes in cardiac output on pregnancy are a result of stroke volume. However, during the mid-second trimester, stroke volume plateaus while heart rate continues to rise, becoming the major contributor to cardiac output in the latter half of pregnancy. During labor, cardiac output is further increased by the autotransfusion of blood from the uterus during a uterine contraction and maternal expulsive efforts. This can lead to an increase of up to 500cc of blood within seconds into the systemic circulation, which can significantly impact cardiac output and stroke volume.
Following delivery, many of these cardiovascular changes reverse in the first 2 weeks postpartum with further normalization toward preconception values 3-12 months later. Women without heart disease adapt well and adverse events are generally rare. However, the stress induced by these antenatal changes can cause a patient with underlying disease to decompensate during the latter half of pregnancy and more specifically, intrapartum when these changes peak. Studies on maternal morbidity attributable to cardiac disease in the United States have shown the most likely time for an adverse cardiac event is intrapartum and immediately postpartum, owing to the drastic and acute changes in hemodynamic status during these time periods. Without an invasive monitor (PAC), hemodynamic monitoring during these time relies on surrogate markers such as blood pressure or heart rate.
There is relatively scarce data on continuous hemodynamic profiles in women with both congenital and acquired heart disease in pregnancy, specifically during labor. Previous literature on the use of invasive monitoring (PAC) during pregnancy have been performed only intermittently during the labor and postpartum process. However, the hemodynamic status during the second and third labor stages is not static and therefore the need for continuous evaluation cannot be underscored.
The increased morbidity associated with invasive monitoring limits the use of pulmonary artery catheters in the pregnant population and therefore a non-invasive way to obtain hemodynamic profiles in women with heart disease is desirable. The non-invasive cardiac output monitor (NICOM) is based on bio-reactance technology and is operator-independent, allowing negligible inter-observer variability in data collection and ease of use. Measurements of cardiac output and stroke volume are not dependent on the distance between the electrodes, which can significantly increase the accuracy of the results. It involves the application of four sensors on the thorax. Changes in aortic blood flow drive phase shifts of propagating waves which are detected by the sensors as the frequency changes. These changes correlate with instantaneous changes in blood volume and blood flow in the aorta. Bio-reactance has been validated against pulmonary artery catheters in non-pregnant populations which manifest various forms of hemodynamic instability and following cardiac surgery.
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. Its readings have been shown in multiple studies to correlate well with PAC in the non-pregnant population. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations. However, it has not been validated in the pregnant, structurally abnormal heart i.e. congenital cardiac disease, as this was exclusion criteria in the aforementioned studies. Establishing normative values during the second stage of labor utilizing the NICOM in women with congenital cardiac disease has the potential to be clinically useful in developing goal-directed management therapy for these women.
- Being tested
- NICOM (non-invasive cardiac output monitor)
- Keywords
- Non-invasive cardiac output monitor, Cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: NICOM (non-invasive cardiac output monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 year recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start17 Oct 2018
- Primary completion30 Jun 2022
- Study completion11 Aug 2022
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Heart Diseases in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen L Florio, DO, Principal investigator, Saint Luke's Hospital of Kansas City/UMKC Assistant Professor, MFM Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616730
- Sponsor's protocol ID
- 18-062
- Status last verified
- Aug 2022
- First submitted
- 25 Jul 2018
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Canobbio MM, Warnes CA, Aboulhosn J, Connolly HM, Khanna A, Koos BJ, Mital S, Rose C, Silversides C, Stout K; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; and Council on Quality of Care and Outcomes Research. Management of Pregnancy in Patients With Complex Congenital Heart Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2017 Feb 21;135(8):e50-e87. doi: 10.1161/CIR.0000000000000458. Epub 2017 Jan 12.
PubMed 28082385Velissaris D, Karamouzos V, Kotroni I, Pierrakos C, Karanikolas M. The Use of Pulmonary Artery Catheter in Sepsis Patients: A Literature Review. J Clin Med Res. 2016 Nov;8(11):769-776. doi: 10.14740/jocmr2719w. Epub 2016 Sep 29.
PubMed 27738477Cornette J, Laker S, Jeffery B, Lombaard H, Alberts A, Rizopoulos D, Roos-Hesselink JW, Pattinson RC. Validation of maternal cardiac output assessed by transthoracic echocardiography against pulmonary artery catheterization in severely ill pregnant women: prospective comparative study and systematic review. Ultrasound Obstet Gynecol. 2017 Jan;49(1):25-31. doi: 10.1002/uog.16015. Epub 2016 Nov 28.
PubMed 27404397Ohashi Y, Ibrahim H, Furtado L, Kingdom J, Carvalho JC. Non-invasive hemodynamic assessment of non-pregnant, healthy pregnant and preeclamptic women using bioreactance. [corrected]. Rev Bras Anestesiol. 2010 Nov-Dec;60(6):603-13, 335-40. doi: 10.1016/S0034-7094(10)70075-1. English, Portuguese, Spanish.
PubMed 21146056Keren H, Burkhoff D, Squara P. Evaluation of a noninvasive continuous cardiac output monitoring system based on thoracic bioreactance. Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H583-9. doi: 10.1152/ajpheart.00195.2007. Epub 2007 Mar 23.
PubMed 17384132Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26.
PubMed 17458538Vinayagam D, Patey O, Thilaganathan B, Khalil A. Cardiac output assessment in pregnancy: comparison of two automated monitors with echocardiography. Ultrasound Obstet Gynecol. 2017 Jan;49(1):32-38. doi: 10.1002/uog.15915.
PubMed 26970353McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
PubMed 28733057Roberts LA, Ling HZ, Poon LC, Nicolaides KH, Kametas NA. Maternal hemodynamics, fetal biometry and Doppler indices in pregnancies followed up for suspected fetal growth restriction. Ultrasound Obstet Gynecol. 2018 Oct;52(4):507-514. doi: 10.1002/uog.19067.
PubMed 29607557Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.
PubMed 12510037Mabie WC, DiSessa TG, Crocker LG, Sibai BM, Arheart KL. A longitudinal study of cardiac output in normal human pregnancy. Am J Obstet Gynecol. 1994 Mar;170(3):849-56. doi: 10.1016/s0002-9378(94)70297-7.
PubMed 8141215Hunter S, Robson SC. Adaptation of the maternal heart in pregnancy. Br Heart J. 1992 Dec;68(6):540-3. doi: 10.1136/hrt.68.12.540.
PubMed 1467047Dyer RA, James MF. Maternal hemodynamic monitoring in obstetric anesthesia. Anesthesiology. 2008 Nov;109(5):765-7. doi: 10.1097/ALN.0b013e31818a3825. No abstract available.
PubMed 18946283Engoren M, Barbee D. Comparison of cardiac output determined by bioimpedance, thermodilution, and the Fick method. Am J Crit Care. 2005 Jan;14(1):40-5.
PubMed 15608107Lee W, Rokey R, Cotton DB. Noninvasive maternal stroke volume and cardiac output determinations by pulsed Doppler echocardiography. Am J Obstet Gynecol. 1988 Mar;158(3 Pt 1):505-10. doi: 10.1016/0002-9378(88)90014-2.
PubMed 3348311
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-invasive Cardiac Output Monitor (NICOM) in Pregnant Women With Structural Heart Disease
- ClinicalTrials.gov ID
- NCT03616730
- Acronym / sponsor ID
- 18-062
- Keywords
- Non-invasive cardiac output monitor, Cardiac output
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major hormonal and hemodynamic changes occur in the cardiovascular system in pregnancy that can unmask and impact underlying cardiac disease. Cardiac output can rise by up to 50% throughout gestation, with an additional 30% rise intrapartum. This increase is multifactorial, owing to an increase of 50% in maternal blood volume during pregnancy, a decrease in afterload due to a decline in systemic vascular resistance and a rise in the maternal heart rate of up to 20 beats per minute. Cardiac output has been the most extensively studied physiologic parameter of cardiac performance during pregnancy, and is dependent on both heart rate and stroke volume. Most of the changes in cardiac output on pregnancy are a result of stroke volume. However, during the mid-second trimester, stroke volume plateaus while heart rate continues to rise, becoming the major contributor to cardiac output in the latter half of pregnancy. During labor, cardiac output is further increased by the autotransfusion of blood from the uterus during a uterine contraction and maternal expulsive efforts. This can lead to an increase of up to 500cc of blood within seconds into the systemic circulation, which can significantly impact cardiac output and stroke volume.
Following delivery, many of these cardiovascular changes reverse in the first 2 weeks postpartum with further normalization toward preconception values 3-12 months later. Women without heart disease adapt well and adverse events are generally rare. However, the stress induced by these antenatal changes can cause a patient with underlying disease to decompensate during the latter half of pregnancy and more specifically, intrapartum when these changes peak. Studies on maternal morbidity attributable to cardiac disease in the United States have shown the most likely time for an adverse cardiac event is intrapartum and immediately postpartum, owing to the drastic and acute changes in hemodynamic status during these time periods. Without an invasive monitor (PAC), hemodynamic monitoring during these time relies on surrogate markers such as blood pressure or heart rate.
There is relatively scarce data on continuous hemodynamic profiles in women with both congenital and acquired heart disease in pregnancy, specifically during labor. Previous literature on the use of invasive monitoring (PAC) during pregnancy have been performed only intermittently during the labor and postpartum process. However, the hemodynamic status during the second and third labor stages is not static and therefore the need for continuous evaluation cannot be underscored.
The increased morbidity associated with invasive monitoring limits the use of pulmonary artery catheters in the pregnant population and therefore a non-invasive way to obtain hemodynamic profiles in women with heart disease is desirable. The non-invasive cardiac output monitor (NICOM) is based on bio-reactance technology and is operator-independent, allowing negligible inter-observer variability in data collection and ease of use. Measurements of cardiac output and stroke volume are not dependent on the distance between the electrodes, which can significantly increase the accuracy of the results. It involves the application of four sensors on the thorax. Changes in aortic blood flow drive phase shifts of propagating waves which are detected by the sensors as the frequency changes. These changes correlate with instantaneous changes in blood volume and blood flow in the aorta. Bio-reactance has been validated against pulmonary artery catheters in non-pregnant populations which manifest various forms of hemodynamic instability and following cardiac surgery.
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. Its readings have been shown in multiple studies to correlate well with PAC in the non-pregnant population. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations. However, it has not been validated in the pregnant, structurally abnormal heart i.e. congenital cardiac disease, as this was exclusion criteria in the aforementioned studies. Establishing normative values during the second stage of labor utilizing the NICOM in women with congenital cardiac disease has the potential to be clinically useful in developing goal-directed management therapy for these women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Disease in pregnancy group | – | Diagnostic Test: NICOM (non-invasive cardiac output monitor)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. |
| Control Group | – | Diagnostic Test: NICOM (non-invasive cardiac output monitor)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- CONTROL GROUP:
- singleton pregnancy
- > 18 years of age
- enrolled in first trimester of pregnancy
- planning delivery at Saint Luke's Hospital of Kansas City
Key exclusion criteria (8 listed)
- 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
- no hypertension, diabetes, multiple gestations, preeclampsia, autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICOM (non-invasive cardiac output monitor)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. | Diagnostic test | Control Group, Heart Disease in pregnancy group |
Primary outcome
Non-inferiority between NICOM and echocardiogram cardiac output measurements
Time frame: 3 year recruitment
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.
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 28082385Canobbio MM, Warnes CA, Aboulhosn J, Connolly HM, Khanna A, Koos BJ, Mital S, Rose C, Silversides C, Stout K; American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; and Council on Quality of Care and Outcomes Research. Management of Pregnancy in Patients With Complex Congenital Heart Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2017 Feb 21;135(8):e50-e87. doi: 10.1161/CIR.0000000000000458. Epub 2017 Jan 12.
- Background: PubMed 27738477Velissaris D, Karamouzos V, Kotroni I, Pierrakos C, Karanikolas M. The Use of Pulmonary Artery Catheter in Sepsis Patients: A Literature Review. J Clin Med Res. 2016 Nov;8(11):769-776. doi: 10.14740/jocmr2719w. Epub 2016 Sep 29.
- Background: PubMed 27404397Cornette J, Laker S, Jeffery B, Lombaard H, Alberts A, Rizopoulos D, Roos-Hesselink JW, Pattinson RC. Validation of maternal cardiac output assessed by transthoracic echocardiography against pulmonary artery catheterization in severely ill pregnant women: prospective comparative study and systematic review. Ultrasound Obstet Gynecol. 2017 Jan;49(1):25-31. doi: 10.1002/uog.16015. Epub 2016 Nov 28.
- Background: PubMed 21146056Ohashi Y, Ibrahim H, Furtado L, Kingdom J, Carvalho JC. Non-invasive hemodynamic assessment of non-pregnant, healthy pregnant and preeclamptic women using bioreactance. [corrected]. Rev Bras Anestesiol. 2010 Nov-Dec;60(6):603-13, 335-40. doi: 10.1016/S0034-7094(10)70075-1. English, Portuguese, Spanish.
- Background: PubMed 17384132Keren H, Burkhoff D, Squara P. Evaluation of a noninvasive continuous cardiac output monitoring system based on thoracic bioreactance. Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H583-9. doi: 10.1152/ajpheart.00195.2007. Epub 2007 Mar 23.
- Background: PubMed 17458538Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26.
- Background: PubMed 26970353Vinayagam D, Patey O, Thilaganathan B, Khalil A. Cardiac output assessment in pregnancy: comparison of two automated monitors with echocardiography. Ultrasound Obstet Gynecol. 2017 Jan;49(1):32-38. doi: 10.1002/uog.15915.
- Background: PubMed 28733057McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
- Background: PubMed 29607557Roberts LA, Ling HZ, Poon LC, Nicolaides KH, Kametas NA. Maternal hemodynamics, fetal biometry and Doppler indices in pregnancies followed up for suspected fetal growth restriction. Ultrasound Obstet Gynecol. 2018 Oct;52(4):507-514. doi: 10.1002/uog.19067.
- Background: PubMed 12510037Sandham JD, Hull RD, Brant RF, Knox L, Pineo GF, Doig CJ, Laporta DP, Viner S, Passerini L, Devitt H, Kirby A, Jacka M; Canadian Critical Care Clinical Trials Group. A randomized, controlled trial of the use of pulmonary-artery catheters in high-risk surgical patients. N Engl J Med. 2003 Jan 2;348(1):5-14. doi: 10.1056/NEJMoa021108.
- Background: PubMed 8141215Mabie WC, DiSessa TG, Crocker LG, Sibai BM, Arheart KL. A longitudinal study of cardiac output in normal human pregnancy. Am J Obstet Gynecol. 1994 Mar;170(3):849-56. doi: 10.1016/s0002-9378(94)70297-7.
- Background: PubMed 1467047Hunter S, Robson SC. Adaptation of the maternal heart in pregnancy. Br Heart J. 1992 Dec;68(6):540-3. doi: 10.1136/hrt.68.12.540.
- Up to Date articleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Florio, DO principal investigator
Saint Luke's Hospital of Kansas City/UMKC Assistant Professor, MFM Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases in Pregnancy and Congenital Heart Disease in Pregnancy, run by Saint Luke's Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority between NICOM and echocardiogram cardiac output measurements (time frame: 3 year recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03616730, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.