Prophylaxis of hypotension in Caesarean Section: comparison between plasma expander hydroxyethyl starch and isotonic polyelectrolytic balanced solution. - OST-01-2009

• Conditions: caesarean section; MedDRA version: 9.1Level: LLTClassification code 10006921

• Registration Number: EUCTR2009-014302-34-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-07
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

? 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified