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Completed

NCT Number: 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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-Type natriuretic peptide (BNP) serum values

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

Device

Pulmonary echography:

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

Urine collection

Other

6 hour and 24 hour urine collection after Cesarean Section

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Udine

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2019
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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