Determination of plasma concentration of levobupivicaine following low concentration epidural infusion of levobupivicaine in pre-eclamptic and non pre-eclamptic nulliparous women.
- Conditions
- This clinical trial is an non-interventional observational clinical study, measuring the plasma levels of the levobupivicaine during labour with an epidural infusion. We will measure levels in pre-eclamptic and non pre-eclamptic women.
- Registration Number
- EUCTR2005-002534-35-IE
- Lead Sponsor
- Coombe Women's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 50
Nulliparous women
Minimum of 38 weeks gestation
Booked to undergo elective/semi-elective induction of labour
50% will have pre-ecclampsia (as defined by the presence of proteinuria and hypertension) and 50% will have not have pre-ecclampsia
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
Known hypersensitivity to amide type local anaesthetic agents
Diseases complicating the pregnancy except pre-eclampsia
Presence of contra-indications to labour epidural analgesia
Maternal refusal to receive epidural analgesia
Previous back surgery/ instrumentation
Weight >110 Kg and height <150 cm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method