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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004824-38-BE

Enrollment

Registered

2006-01-31

Start date

2005-12-13

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 ?

Interventions

Trade Name: Hartmann Product Name: Ringer lactaat Pharmaceutical Form: Intravenous infusion CAS Number: 72-17-3 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 100

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 registrate the incidence of arterial hypotension after CSE is performed. It will be checked if there is a correlation between the administration of extra fluid before the CSE is performed and the incidence of arterial hypotension.;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 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 registrate the incidence of arterial hypotension after CSE is performed. It will be checked if there is a correlation between the administration of extra fluid before the CSE is performed and the incidence of arterial hypotension.;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 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