caesarean section MedDRA version: 9.1 Level: LLT Classification code 10006921
Conditions
Interventions
Trade Name: STEROFUNDIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: SODIO CLORURO
CAS Number: 7647-14-5
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acquisition of Informed Consent; ? ASA 1-2; ? aged between 18 and 40 years, ? height of between 150-170 cm, ? body weight between 50 and 90 kg, ? undergoing caesarean in election or in planned emergency. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? obstetric pathologies with hemorrhagic risk (central placenta ..) ? twin pregnancies and plurigemine, ? congenital or acquired abnormalities of coagulation, ? permagna obesity, ? skin infections or previous or current diseases of the spine, ? patients with ASA> 2, ? Patients undergoing urgent cesarean section ? serious medical conditions that, in the opinion of the investigator, contraindicated inclusion of patient participation in the study; ? use of experimental drugs in the last two months before inclusion in the study. ? Patients unable to follow the procedures laid down by the Protocol and to sign informed consent. In the case of patients unable to give informed consent to the study, the procedure must be provided and signed by guardian or legal representative. Patients, that are unable to sign the consent, must sign as they are able to do so.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Determine the differences between plasma expander and polyelectrolitic solution in terms of efficacy and safety in the prevention and in the treatment of hypotension and hypovolemia in caesarean section by spinal anesthesia. This evaluation will be done by measuring patient?s intra-operative and in series blood pressure and heart rate.;Main Objective: Determine the differences between plasma expander and polyelectrolitic solution in terms of efficacy and safety in the prevention and in the treatment of hypotension and hypovolemia in caesarean section by spinal anesthesia. This evaluation will be done by measuring patient?s intra-operative and in series blood pressure and heart rate.;Secondary Objective: 1) vitality of the newborn at birth assessed by Apgar index. 2) any peri-natal distress assessed with EGA umbilical venous blood (cloremia, acidosis) 3) absence of side effects of hypotension in pregnant, such as nausea, vomiting, peripheral hypoperfusion 4) no need for blood transfusions 5) no need for sympathomimetic | — |
Countries
Italy
Outcome results
None listed