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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004629-28-BE

Enrollment

100

Registered

2006-09-04

Start date

2006-10-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Voluven Pharmaceutical Form: Intravenous infusion CAS Number: 9004-62-0 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 500- Trade Name: Hartmann Phar

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 - Registration of neonatal outcome (Apgar-score and fetal bloodgasses) - Registration of the time of labour - 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 ?	—

Measure

Time frame

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 - Registration of neonatal outcome (Apgar-score and fetal bloodgasses) - Registration of the time of labour - 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 ?

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026