Pregnancy RelatedNCT03851679
Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia
An observational study of Pregnancy Related, run by University of Udine.
Trial summary
Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected. Vascular permeability is controlled by endothelial glycocalyx. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- B-Type natriuretic peptide (BNP) serum values, Pulmonary echography and urine collection
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2016to Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients' anthropometric data were collected, data related to the anesthetic technique, pharmacological and intraoperative fluid therapy, sensory level reached after subarachnoid anesthesia, sensory level and motor blockade at discharge from the operating room. We also collected BNP serum values and pulmonary ultrasound images at 6 and 24 h after the intervention. Diuresis collection at 6 and 24 h after the intervention was registered as well as water balance.
Who may be able to join
- woman submit elective Cesarean Section:
- age > 18 years
- American Society of Anesthesiologists (ASA) physical status classification system > 2
- > 37 gestational age
- arterial pressure >/ = 140/90 mmHg and proteinuria < 300 mmHg during anesthesia pre-examination
- no known cardiovascular/respiratory disease
- pre-partum pulmonary echography
Who cannot join
- age < 18 years
- pulmonary echographic windows not satisfying
- blood loss during Cesarean Section more than 1000 mL and/or necessity to administer colloid
- postpartum hemorrhage within the first 24 hours following childbirth
- pre-eclamptic sign/symptoms within the first 5 days following childbirth
- twin pregnancy
About this study
Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected.
Vascular permeability is controlled by endothelial glycocalyx. Several factors such as sepsis, ischemia / reperfusion, inflammatory mediators, trauma, surgery including the Cesarean Section and fluid overload can increase vascular permeability due to a glycocalyx damage.
Read more
During Cesarean Section under subarachnoid anesthesia, hypotension may occur. It is a common side effect caused by reduced preload due to aortocaval compression by the uterus. Furthermore, subarachnoid anesthesia causes block of the sympathetic preganglionic fibers which is associated with vasodilation. These changes often require the use of vasopressors and fluids.
A fluid overload associated with the physiological and pathological factors discussed earlier might cause an increased risk of pulmonary edema and acute respiratory failure (IRA) in women undergoing cesarean section under arachnoid anesthesia.
IRA occurs in less than 0.2% of total pregnancies but it is one of the most common cause of admission to intensive care unit in pregnant women.
Among the causes that can lead to IRA in the last trimester of pregnancy we find pneumopathies such as asthma, pulmonary embolism due to amniotic fluid and pulmonary edema related to severe preeclampsia.
Diagnosis of pulmonary edema can be clinical or sub-clinical through laboratory tests such as BNP (b-type natriuretic peptide). It might also be necessary to execute instrumental examinations such as chest radiography (contraindicated in pregnancy) or trans-thoracic ultrasound.
Hypothesis: correlation between subarachnoid anesthesia, fluidic therapy and BNP values and ultrasound pattern
- Conditions
- Pregnancy Related
- Being tested
- B-Type natriuretic peptide (BNP) serum values, Pulmonary echography, urine collection
- Keywords
- pulmonary echography, B-Type natriuretic peptide, Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Type natriuretic peptide (BNP) serum valuesDiagnostic test
evaluation BNP serum values:
- pre- Cesarean Section (30 minutes before surgery)
- post- Cesarean Section (6 hour and 24 hour after surgery)
Pulmonary echographyDevice
Pulmonary echography:
- pre- Cesarean Section (30 minutes before surgery)
- post- Cesarean Section (6 hour and 24 hour after surgery)
urine collectionOther
6 hour and 24 hour urine collection after Cesarean Section
| Study group | Role | What they receive |
|---|---|---|
| pregnancy woman | woman who are submitted to elective Cesarean Section in spinal anesthesia Receives: Diagnostic Test: B-Type natriuretic peptide (BNP) serum values; Device: Pulmonary echography; Other: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound pulmonary variations
The main goal of our study is to evaluate, preoperatively, the incidence of ultrasound pulmonary variations in pregnant women attending elective Cesarean Section
Measured: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
Secondary outcomes (3)
subclinical pulmonary echography variation
Evaluating the incidence of subclinical variations in ecographic lung characteristics at 6 and 24 hours after Cesarean Section
Measured: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
B-type natriuretic peptide serum value variation
Finding if there is any correlation between preoperative b-type natriuretic peptide and ecographic lung characteristics in pregnants, before and 24 hours after Cesarean Section
Measured: B-type natriuretic peptide serum level is sampled 30 minutes before Cesarean Section, 6 and 24 hours after surgery 30 minutes before Cesarean Section, 6 and 24 hours after surgery
fluid administration and pulmonary echography variation
Finding if there is any correlation between intraoperative fluids administered and ecographic lung characteristics
Measured: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start17 Dec 2016
- Primary completion8 Aug 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bove, University of Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851679
- Sponsor's protocol ID
- BNP and pulmonary echography
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bamfo JE, Kametas NA, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic and systolic long-axis function during normal pregnancy. Eur J Echocardiogr. 2007 Oct;8(5):360-8. doi: 10.1016/j.euje.2006.12.004. Epub 2007 Feb 23.
PubMed 17321800Campos O, Andrade JL, Bocanegra J, Ambrose JA, Carvalho AC, Harada K, Martinez EE. Physiologic multivalvular regurgitation during pregnancy: a longitudinal Doppler echocardiographic study. Int J Cardiol. 1993 Jul 15;40(3):265-72. doi: 10.1016/0167-5273(93)90010-e.
PubMed 8225661Lapinsky SE. Acute respiratory failure in pregnancy. Obstet Med. 2015 Sep;8(3):126-32. doi: 10.1177/1753495X15589223. Epub 2015 Jun 10.
PubMed 27512467Pereira A, Krieger BP. Pulmonary complications of pregnancy. Clin Chest Med. 2004 Jun;25(2):299-310. doi: 10.1016/j.ccm.2004.01.010.
PubMed 15099890Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
PubMed 18813052Resnik JL, Hong C, Resnik R, Kazanegra R, Beede J, Bhalla V, Maisel A. Evaluation of B-type natriuretic peptide (BNP) levels in normal and preeclamptic women. Am J Obstet Gynecol. 2005 Aug;193(2):450-4. doi: 10.1016/j.ajog.2004.12.006.
PubMed 16098869
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03851679
- Acronym / sponsor ID
- BNP and pulmonary echography
- Conditions
- Pregnancy Related
- Keywords
- pulmonary echography, B-Type natriuretic peptide, Spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 22 Feb 2019 (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.
Pregnancy is characterized by many biohumoral changes: circulation, respiratory mechanics, oncotic pressure, vascular permeability and many other systems are affected.
Vascular permeability is controlled by endothelial glycocalyx. Several factors such as sepsis, ischemia / reperfusion, inflammatory mediators, trauma, surgery including the Cesarean Section and fluid overload can increase vascular permeability due to a glycocalyx damage.
During Cesarean Section under subarachnoid anesthesia, hypotension may occur. It is a common side effect caused by reduced preload due to aortocaval compression by the uterus. Furthermore, subarachnoid anesthesia causes block of the sympathetic preganglionic fibers which is associated with vasodilation. These changes often require the use of vasopressors and fluids.
A fluid overload associated with the physiological and pathological factors discussed earlier might cause an increased risk of pulmonary edema and acute respiratory failure (IRA) in women undergoing cesarean section under arachnoid anesthesia.
IRA occurs in less than 0.2% of total pregnancies but it is one of the most common cause of admission to intensive care unit in pregnant women.
Among the causes that can lead to IRA in the last trimester of pregnancy we find pneumopathies such as asthma, pulmonary embolism due to amniotic fluid and pulmonary edema related to severe preeclampsia.
Diagnosis of pulmonary edema can be clinical or sub-clinical through laboratory tests such as BNP (b-type natriuretic peptide). It might also be necessary to execute instrumental examinations such as chest radiography (contraindicated in pregnancy) or trans-thoracic ultrasound.
Hypothesis: correlation between subarachnoid anesthesia, fluidic therapy and BNP values and ultrasound pattern
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnancy woman | – | Diagnostic Test: B-Type natriuretic peptide (BNP) serum values, Device: Pulmonary echography, Other: urine collectionwoman who are submitted to elective Cesarean Section in spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' anthropometric data were collected, data related to the anesthetic technique, pharmacological and intraoperative fluid therapy, sensory level reached after subarachnoid anesthesia, sensory level and motor blockade at discharge from the operating room. We also collected BNP serum values and pulmonary ultrasound images at 6 and 24 h after the intervention. Diuresis collection at 6 and 24 h after the intervention was registered as well as water balance.
Key inclusion criteria (7 listed)
- age > 18 years
- American Society of Anesthesiologists (ASA) physical status classification system > 2
- > 37 gestational age
- arterial pressure >/ = 140/90 mmHg and proteinuria < 300 mmHg during anesthesia pre-examination
- no known cardiovascular/respiratory disease
Key exclusion criteria (6 listed)
- age < 18 years
- pulmonary echographic windows not satisfying
- blood loss during Cesarean Section more than 1000 mL and/or necessity to administer colloid
- postpartum hemorrhage within the first 24 hours following childbirth
- pre-eclamptic sign/symptoms within the first 5 days following childbirth
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 |
|---|---|---|
| B-Type natriuretic peptide (BNP) serum valuesevaluation BNP serum values: * pre- Cesarean Section (30 minutes before surgery) * post- Cesarean Section (6 hour and 24 hour after surgery) | Diagnostic test | pregnancy woman |
| Pulmonary echographyPulmonary echography: * pre- Cesarean Section (30 minutes before surgery) * post- Cesarean Section (6 hour and 24 hour after surgery) | Device | pregnancy woman |
| urine collection6 hour and 24 hour urine collection after Cesarean Section | Other | pregnancy woman |
Primary outcome
Ultrasound pulmonary variations
Time frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
The main goal of our study is to evaluate, preoperatively, the incidence of ultrasound pulmonary variations in pregnant women attending elective Cesarean Section
3 secondary outcomes
subclinical pulmonary echography variation
Time frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
B-type natriuretic peptide serum value variation
Time frame: B-type natriuretic peptide serum level is sampled 30 minutes before Cesarean Section, 6 and 24 hours after surgery 30 minutes before Cesarean Section, 6 and 24 hours after surgery
fluid administration and pulmonary echography variation
Time frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
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 22 Feb 2019.
- Background: PubMed 17321800Bamfo JE, Kametas NA, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic and systolic long-axis function during normal pregnancy. Eur J Echocardiogr. 2007 Oct;8(5):360-8. doi: 10.1016/j.euje.2006.12.004. Epub 2007 Feb 23.
- Background: PubMed 8225661Campos O, Andrade JL, Bocanegra J, Ambrose JA, Carvalho AC, Harada K, Martinez EE. Physiologic multivalvular regurgitation during pregnancy: a longitudinal Doppler echocardiographic study. Int J Cardiol. 1993 Jul 15;40(3):265-72. doi: 10.1016/0167-5273(93)90010-e.
- Background: PubMed 27512467Lapinsky SE. Acute respiratory failure in pregnancy. Obstet Med. 2015 Sep;8(3):126-32. doi: 10.1177/1753495X15589223. Epub 2015 Jun 10.
- Background: PubMed 15099890Pereira A, Krieger BP. Pulmonary complications of pregnancy. Clin Chest Med. 2004 Jun;25(2):299-310. doi: 10.1016/j.ccm.2004.01.010.
- Background: PubMed 18813052Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.
- Background: PubMed 16098869Resnik JL, Hong C, Resnik R, Kazanegra R, Beede J, Bhalla V, Maisel A. Evaluation of B-type natriuretic peptide (BNP) levels in normal and preeclamptic women. Am J Obstet Gynecol. 2005 Aug;193(2):450-4. doi: 10.1016/j.ajog.2004.12.006.
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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 Related, run by University of Udine.
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 7 inclusion and 6 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 22 Feb 2019. 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?
Ultrasound pulmonary variations (time frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery). 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 NCT03851679, which also lists 6 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 22 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.