Een gecombineerde spinale epidurale anesthesie (CSE) bij arbeid : nood aan een fluid load (colloïden) ?

Conditions: Combined spinal epidural analgesia during labour : necessity of a fluid load with colloids ?

Registration Number: EUCTR2006-004629-28-BE

Lead Sponsor: Z Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 100

Inclusion Criteria

- ASA 1 and 2
- singleton pregnancy
- > 36 weeks post conception
- normal pregnancy
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

- prematuritas
- ASA 3 and 4
- arterial hypertension or pre-eclampsia
- allergy to local anesthetics
- suspicion of a fetal congenital disorder
- signs of fetal distress
- coagulation disorders

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary goal of this study is to register the incidence of arterial hypotension after CSE is performed and to evaluate the prophylactic use of colloïds (500 ml Voluven IV) in comparison with crystalloids (1000 ml Ringer lactate) in the prevention of arterial hypotension after CSE.;Secondary Objective: - Evaluation of fetal well-being<br>- Registration of neonatal outcome (Apgar-score and fetal bloodgasses)<br>- Registration of the time of labour<br>- Registration of adverse events.;Primary end point(s): Is there a correlation between the administration of extra fluid (colloids) before the combined spinal epidural technique is performed and the incidence of arterial hypotension ?

Secondary Outcome Measures