- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851679
Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pregnancy woman
woman who are submitted to elective Cesarean Section in spinal anesthesia
|
evaluation BNP serum values:
Pulmonary echography:
6 hour and 24 hour urine collection after Cesarean Section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subclinical pulmonary echography variation
Time Frame: pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
|
Evaluating the incidence of subclinical variations in ecographic lung characteristics at 6 and 24 hours after Cesarean Section
|
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
|
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
|
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
|
Finding if there is any correlation between intraoperative fluids administered and ecographic lung characteristics
|
pulmonary echography is made 30 minutes before Cesarean Section, 6 and 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Campos 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.
- Lapinsky SE. Acute respiratory failure in pregnancy. Obstet Med. 2015 Sep;8(3):126-32. doi: 10.1177/1753495X15589223. Epub 2015 Jun 10.
- Pereira A, Krieger BP. Pulmonary complications of pregnancy. Clin Chest Med. 2004 Jun;25(2):299-310. doi: 10.1016/j.ccm.2004.01.010.
- Chappell 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.
- Resnik 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNP and pulmonary echography
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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