Determination of plasma concentration of levobupivicaine following low concentration epidural infusion of levobupivicaine in pre-eclamptic and non pre-eclamptic nulliparous women.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002534-35-IE

Enrollment

Registered

2005-06-13

Start date

2005-09-14

Completion date

Unknown

Last updated

2025-04-14

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

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.

Interventions

Trade Name: Chirocaine 2.5mg/ml Product Name: Chirocaine Product Code: pa 38/71/1 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To determine if there is a difference in plasma levobupivicaine levels following low concentration epidural infusions of levobupivicaine in non pre-eclamptic and pre-eclamptic nulliparous women ;Secondary Objective: 2)To measure maternal plasma levels of albumin, alpha-1-acid glycoprotein and oxytocin to determine if there is a difference between normal and pre-eclamptic nulliparous women 3)To prospectively observe the length of each stage of labour and the mode of delivery in pre-eclamptic and non pre-eclamptic women who undergo induction of labour from 38 weeks gestation;Primary end point(s): The study will be powered to detect a 50% difference between the pre-ecclampsia and non pre-eclampsia plasma levels of the drug Measurement of the induction to delivery interval in pe-eclamptic and non pre-eclamptic nulliparous women	—

Measure

Time frame

Main Objective: 1) To determine if there is a difference in plasma levobupivicaine levels following low concentration epidural infusions of levobupivicaine in non pre-eclamptic and pre-eclamptic nulliparous women ;Secondary Objective: 2)To measure maternal plasma levels of albumin, alpha-1-acid glycoprotein and oxytocin to determine if there is a difference between normal and pre-eclamptic nulliparous women 3)To prospectively observe the length of each stage of labour and the mode of delivery in pre-eclamptic and non pre-eclamptic women who undergo induction of labour from 38 weeks gestation;Primary end point(s): The study will be powered to detect a 50% difference between the pre-ecclampsia and non pre-eclampsia plasma levels of the drug Measurement of the induction to delivery interval in pe-eclamptic and non pre-eclamptic nulliparous women

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Countries

Ireland

Outcome results

None listed

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