Pregnancy ComplicationsNCT03576092
Lung Ultrasound Patterns Preeclampsia
An observational study of Pregnancy Complications and Ultrasound Therapy; Complications, run by Northwell Health.
Trial summary
Evaluation of lung ultrasound as a diagnostic tool in pregnant patients. 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
- Pregnancy Complications, Ultrasound Therapy; Complications, Pulmonary Disease
- What is being tested?
- Lung Ultrasound
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 20 May 2018
- 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: The subject population is 262 pregnant female participants between ages 18 to approximately 49 years old. Pregnant patients must be used in the study population because the objective is to evaluate lung ultrasound as a tool in the pregnant population.
Who may be able to join
- ≥ 18 years old
- Singleton pregnancy
- 32 0/7 weeks - 41 6/7 weeks gestational age
Who cannot join
- Inability to provide informed consent
- Refusal to participate
- Already treated for acute lung pathology prior to enrollment
- Cognitive impairment that precluded understanding of research procedures
About this study
Official title: Lung Ultrasound Patterns in Late Third-trimester Gravidas With and Without Preeclampsia
Evaluation of lung ultrasound as a diagnostic tool in pregnant patients.
Read the detailed description
The objective of this study is to evaluate lung ultrasound as a tool in pregnant patients. This tool has not been well studied in pregnancy but has the potential to detect pulmonary edema in patients with preeclampsia before they become critically ill. In addition, the presence of pulmonary edema is a criterion for the diagnosis for severe preeclampsia, and if detected early, may change management and decrease morbidity in these patients. The investigators hypothesize that healthy pregnant women and women with preeclampsia in the third trimester have normal lung ultrasound patterns in the absence of clinical signs or symptoms of poor lung aeration.
The investigators propose a prospective cross-sectional study to compare pregnant patients with and without a diagnosis of preeclampsia treated at the Long Island Jewish Medical Center (LIJ) and North Shore University Hospital (NSUH) from August 2016 - May 2018. A cohort of healthy gestational age-matched pregnant patients from 32 - 41 weeks without a diagnosis of preeclampsia will serve as controls. Inclusion criteria include singleton pregnancies over 31 6/7 weeks gestational age treated at LIJ or NSUH. Exclusion criteria include age less than 18 years and refusal to participate in the study. Informed consent will be obtained for all study participants.
A diagnosis of preeclampsia will be made based on standard criteria as outlined by the American Congress of Obstetrics and Gynecology (ACOG). Interstitial edema will be defined as an ultrasound finding of three or more B-lines in an interstitial space in two or more lung regions. B-line dominant lung fields are suggestive of alveolar interstitial syndrome. The clinical diagnosis of pulmonary edema is based on findings including dyspnea, tachypnea, tachycardia, hypoxemia (measured by non-invasive pulse oximeter), and diffuse crackles on lung exam. The patient characteristics and ultrasound findings will be compared between the cohort of preeclamptic patients and healthy controls. A secondary analysis will be performed on the images that were obtained before and after magnesium sulfate therapy in patients diagnosed with preeclampsia with severe features to determine the effect on sonographic findings. If a preeclamptic patient received a chest x-ray as part of her management plan because of a clinical suspicion of pulmonary edema, the reported results will be collected and compared to lung sonogram results.
Lung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position. Still images and video clips will be reviewed by an expert in lung ultrasound who is blinded to the patients' clinical information (Dr. Seth Koenig). Lung sonography will be performed on two occasions for each preeclamptic patient who is treated with magnesium sulfate; 1) at the time of diagnosis of preeclampsia, and 2) after completion of magnesium sulfate bolus. Lung sonography will be performed on only one occasion for gestational age-matched controls and for preeclamptic patients who are not treated with magnesium sulfate. Patients will not be given a diagnosis of pulmonary edema nor will their management plans be altered based on the results of the lung sonography performed for this study.
Data will be collected and stored in RedCap. The investigators will collect data on patient demographics, past medical and surgical history, blood pressure measurements at time of diagnosis, results of routine lab values that are drawn for evaluation of preeclamptic patients, and the review of four ultrasound examination regions to determine if they are B-line dominant or A-line dominant. Descriptive statistics and appropriate comparison tests will be used to analyze the data.
- Conditions
- Pregnancy Complications, Ultrasound Therapy; Complications, Pulmonary Disease, Pulmonary Edema
- Being tested
- Lung Ultrasound
- Medical subject headings
- Pregnancy Complications, Lung Diseases, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
Lung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position.
| Study group | Role | What they receive |
|---|---|---|
| Normal Pregnancy | Healthy gestational age-matched pregnant patients from 32 - 41 weeks without a diagnosis of preeclampsia. Receives: Diagnostic Test: Lung Ultrasound | |
| Preeclampsia Pregnancy | Pregnant patients from 32 - 41 weeks with a diagnosis of preeclampsia based on standard criteria as outlined by the American Congress of Obstetrics and Gynecology (ACOG). Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Lung Ultrasound Study
ultrasound finding of three or more B-lines in an interstitial space in two or more lung regions.
Measured: At time of lung ultrasound study, through study completion from August 2016 - May 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start15 Aug 2016
- Primary completion20 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies 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
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576092
- Sponsor's protocol ID
- HS16-0447
- Status last verified
- May 2023
- First submitted
- 29 May 2018
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco PA, Cianciulli TF. Pulmonary Edema Assessed by Ultrasound: Impact in Cardiology and Intensive Care Practice. Echocardiography. 2016 May;33(5):778-87. doi: 10.1111/echo.13182. Epub 2016 Feb 3.
PubMed 26841270Pachtman S, Koenig S, Meirowitz N. Detecting Pulmonary Edema in Obstetric Patients Through Point-of-Care Lung Ultrasonography. Obstet Gynecol. 2017 Mar;129(3):525-529. doi: 10.1097/AOG.0000000000001909.
PubMed 28178063Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.
PubMed 22420683Inchingolo R, Smargiassi A, Mormile F, Marra R, De Carolis S, Lanzone A, Valente S, Corbo GM. Look at the lung: can chest ultrasonography be useful in pregnancy? Multidiscip Respir Med. 2014 Jun 6;9(1):32. doi: 10.1186/2049-6958-9-32. eCollection 2014.
PubMed 24936303Malek G, Drygalska A, Kober J, Wawrzynska L, Debski R, Dabrowski M, Torbicki A. [Chest ultrasound in the diagnosis of pulmonary embolism in a pregnant patient - a case report]. Pneumonol Alergol Pol. 2009;77(6):560-4. Polish.
PubMed 20013708Samol JM, Lambers DS. Magnesium sulfate tocolysis and pulmonary edema: the drug or the vehicle? Am J Obstet Gynecol. 2005 May;192(5):1430-2. doi: 10.1016/j.ajog.2005.02.093.
PubMed 15902128Sibai BM, Mabie BC, Harvey CJ, Gonzalez AR. Pulmonary edema in severe preeclampsia-eclampsia: analysis of thirty-seven consecutive cases. Am J Obstet Gynecol. 1987 May;156(5):1174-9. doi: 10.1016/0002-9378(87)90135-9.
PubMed 3578433Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
PubMed 16984837
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Patterns in Late Third-trimester Gravidas With and Without Preeclampsia
- ClinicalTrials.gov ID
- NCT03576092
- Acronym / sponsor ID
- HS16-0447
- Conditions
- Pregnancy Complications, Ultrasound Therapy; Complications, Pulmonary Disease, Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 3 Jul 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.
Evaluation of lung ultrasound as a diagnostic tool in pregnant patients.
Detailed description
The objective of this study is to evaluate lung ultrasound as a tool in pregnant patients. This tool has not been well studied in pregnancy but has the potential to detect pulmonary edema in patients with preeclampsia before they become critically ill. In addition, the presence of pulmonary edema is a criterion for the diagnosis for severe preeclampsia, and if detected early, may change management and decrease morbidity in these patients. The investigators hypothesize that healthy pregnant women and women with preeclampsia in the third trimester have normal lung ultrasound patterns in the absence of clinical signs or symptoms of poor lung aeration.
The investigators propose a prospective cross-sectional study to compare pregnant patients with and without a diagnosis of preeclampsia treated at the Long Island Jewish Medical Center (LIJ) and North Shore University Hospital (NSUH) from August 2016 - May 2018. A cohort of healthy gestational age-matched pregnant patients from 32 - 41 weeks without a diagnosis of preeclampsia will serve as controls. Inclusion criteria include singleton pregnancies over 31 6/7 weeks gestational age treated at LIJ or NSUH. Exclusion criteria include age less than 18 years and refusal to participate in the study. Informed consent will be obtained for all study participants.
A diagnosis of preeclampsia will be made based on standard criteria as outlined by the American Congress of Obstetrics and Gynecology (ACOG). Interstitial edema will be defined as an ultrasound finding of three or more B-lines in an interstitial space in two or more lung regions. B-line dominant lung fields are suggestive of alveolar interstitial syndrome. The clinical diagnosis of pulmonary edema is based on findings including dyspnea, tachypnea, tachycardia, hypoxemia (measured by non-invasive pulse oximeter), and diffuse crackles on lung exam. The patient characteristics and ultrasound findings will be compared between the cohort of preeclamptic patients and healthy controls. A secondary analysis will be performed on the images that were obtained before and after magnesium sulfate therapy in patients diagnosed with preeclampsia with severe features to determine the effect on sonographic findings. If a preeclamptic patient received a chest x-ray as part of her management plan because of a clinical suspicion of pulmonary edema, the reported results will be collected and compared to lung sonogram results.
Lung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position. Still images and video clips will be reviewed by an expert in lung ultrasound who is blinded to the patients' clinical information (Dr. Seth Koenig). Lung sonography will be performed on two occasions for each preeclamptic patient who is treated with magnesium sulfate; 1) at the time of diagnosis of preeclampsia, and 2) after completion of magnesium sulfate bolus. Lung sonography will be performed on only one occasion for gestational age-matched controls and for preeclamptic patients who are not treated with magnesium sulfate. Patients will not be given a diagnosis of pulmonary edema nor will their management plans be altered based on the results of the lung sonography performed for this study.
Data will be collected and stored in RedCap. The investigators will collect data on patient demographics, past medical and surgical history, blood pressure measurements at time of diagnosis, results of routine lab values that are drawn for evaluation of preeclamptic patients, and the review of four ultrasound examination regions to determine if they are B-line dominant or A-line dominant. Descriptive statistics and appropriate comparison tests will be used to analyze the data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Pregnancy | – | Diagnostic Test: Lung UltrasoundHealthy gestational age-matched pregnant patients from 32 - 41 weeks without a diagnosis of preeclampsia. |
| Preeclampsia Pregnancy | – | Diagnostic Test: Lung UltrasoundPregnant patients from 32 - 41 weeks with a diagnosis of preeclampsia based on standard criteria as outlined by the American Congress of Obstetrics and Gynecology (ACOG). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population is 262 pregnant female participants between ages 18 to approximately 49 years old. Pregnant patients must be used in the study population because the objective is to evaluate lung ultrasound as a tool in the pregnant population.
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Singleton pregnancy
- 32 0/7 weeks - 41 6/7 weeks gestational age
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Refusal to participate
- Already treated for acute lung pathology prior to enrollment
- Cognitive impairment that precluded understanding of research procedures
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 |
|---|---|---|
| Lung UltrasoundLung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position. | Diagnostic test | Normal Pregnancy, Preeclampsia Pregnancy |
Primary outcome
Positive Lung Ultrasound Study
Time frame: At time of lung ultrasound study, through study completion from August 2016 - May 2018.
ultrasound finding of three or more B-lines in an interstitial space in two or more lung regions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Background: PubMed 26841270Blanco PA, Cianciulli TF. Pulmonary Edema Assessed by Ultrasound: Impact in Cardiology and Intensive Care Practice. Echocardiography. 2016 May;33(5):778-87. doi: 10.1111/echo.13182. Epub 2016 Feb 3.
- Background: PubMed 28178063Pachtman S, Koenig S, Meirowitz N. Detecting Pulmonary Edema in Obstetric Patients Through Point-of-Care Lung Ultrasonography. Obstet Gynecol. 2017 Mar;129(3):525-529. doi: 10.1097/AOG.0000000000001909.
- Background: PubMed 22420683Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15.
- Background: PubMed 24936303Inchingolo R, Smargiassi A, Mormile F, Marra R, De Carolis S, Lanzone A, Valente S, Corbo GM. Look at the lung: can chest ultrasonography be useful in pregnancy? Multidiscip Respir Med. 2014 Jun 6;9(1):32. doi: 10.1186/2049-6958-9-32. eCollection 2014.
- Background: PubMed 20013708Malek G, Drygalska A, Kober J, Wawrzynska L, Debski R, Dabrowski M, Torbicki A. [Chest ultrasound in the diagnosis of pulmonary embolism in a pregnant patient - a case report]. Pneumonol Alergol Pol. 2009;77(6):560-4. Polish.
- Background: PubMed 15902128Samol JM, Lambers DS. Magnesium sulfate tocolysis and pulmonary edema: the drug or the vehicle? Am J Obstet Gynecol. 2005 May;192(5):1430-2. doi: 10.1016/j.ajog.2005.02.093.
- Background: PubMed 3578433Sibai BM, Mabie BC, Harvey CJ, Gonzalez AR. Pulmonary edema in severe preeclampsia-eclampsia: analysis of thirty-seven consecutive cases. Am J Obstet Gynecol. 1987 May;156(5):1174-9. doi: 10.1016/0002-9378(87)90135-9.
- Background: PubMed 16984837Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Ultrasound Therapy; Complications, run by Northwell Health.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive Lung Ultrasound Study (time frame: At time of lung ultrasound study, through study completion from August 2016 - May 2018.). 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 NCT03576092, which also lists 8 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 1 Jun 2023.