Pulmonary Echography and BNP Value Pre- and Post- Elective Cesarean Section in Spinal Anesthesia

NCT ID: NCT03851679

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-17

Study Completion Date

2018-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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pregnancy woman

woman who are submitted to elective Cesarean Section in spinal anesthesia

B-Type natriuretic peptide (BNP) serum values

Intervention Type DIAGNOSTIC_TEST

evaluation BNP serum values:

* pre- Cesarean Section (30 minutes before surgery)
* post- Cesarean Section (6 hour and 24 hour after surgery)

Pulmonary echography

Intervention Type DEVICE

Pulmonary echography:

* pre- Cesarean Section (30 minutes before surgery)
* post- Cesarean Section (6 hour and 24 hour after surgery)

urine collection

Intervention Type OTHER

6 hour and 24 hour urine collection after Cesarean Section

Interventions

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B-Type natriuretic peptide (BNP) serum values

evaluation BNP serum values:

* pre- Cesarean Section (30 minutes before surgery)
* post- Cesarean Section (6 hour and 24 hour after surgery)

Intervention Type DIAGNOSTIC_TEST

Pulmonary echography

Pulmonary echography:

* pre- Cesarean Section (30 minutes before surgery)
* post- Cesarean Section (6 hour and 24 hour after surgery)

Intervention Type DEVICE

urine collection

6 hour and 24 hour urine collection after Cesarean Section

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Udine

OTHER

Sponsor Role lead

Responsible Party

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Bove

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 17321800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8225661 (View on PubMed)

Lapinsky SE. Acute respiratory failure in pregnancy. Obstet Med. 2015 Sep;8(3):126-32. doi: 10.1177/1753495X15589223. Epub 2015 Jun 10.

Reference Type BACKGROUND
PMID: 27512467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15099890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18813052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16098869 (View on PubMed)

Other Identifiers

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BNP and pulmonary echography

Identifier Type: -

Identifier Source: org_study_id

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