Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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The investigators previously demonstrated that epidural ropivacaine reduces uterine artery vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted a marked right-left difference in vascular resistance between paired uterine arteries, which was almost completely abolished following epidural ropivacaine. However, this novel observation was not a stated outcome variable before the study began. This study assesses right-left difference in vascular resistance between paired uterine arteries as a primary end-point, assesses the dose-response effect of epidural lidocaine and compares the effect observed in pre-eclampsia with that in two control populations (term normal pregnancy and non-pregnant controls).

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Detailed Description

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Conditions

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Pre-eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Epidural lidocaine

30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant.

Group Type ACTIVE_COMPARATOR

Epidural lidocaine

Intervention Type DRUG

Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

Epidural lidocaine 2%

Intervention Type DRUG

5 x 5ml boluses of either epidural lidocaine 2% or epidural saline

Epidural saline

30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant

Group Type PLACEBO_COMPARATOR

Epidural lidocaine

Intervention Type DRUG

Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

Epidural lidocaine 2%

Intervention Type DRUG

5 x 5ml boluses of either epidural lidocaine 2% or epidural saline

Interventions

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Epidural lidocaine

Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

Intervention Type DRUG

Epidural lidocaine 2%

5 x 5ml boluses of either epidural lidocaine 2% or epidural saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-eclampsia patients and normal pregnancy controls scheduled to receive epidural catheterization for induction of labor or Cesarean delivery. Non-pregnant controls receiving epidural catheterization for elective surgery. Pre-eclampsia group:

1. gestational age between 35 to 40 completed weeks
2. uterine artery notching OR evidence of reduced uterine artery blood flow
3. resting systolic pressure \> 140mmHg or diastolic pressure \> 90mmHg measured twice at least 6 hours apart
4. proteinuria (at least 0•1 g/l in two random samples at least 6 hours apart or at least 0•3g in a 24 hour collection).
* Normal pregnancy control group:

1. gestational age between 35 to 40 completed weeks
2. absence of other inclusion factors for the pre-eclampsia group. Non-pregnant control group: Non-pregnant women of reproductive age.

Exclusion Criteria

* Active labor, resting blood pressure ≥ 160/110 (recorded on at least two occasions 6 hours apart), coagulopathy or other contraindications for epidural catheterization, abnormal fetal heart tracing, known fetal anomaly, intrauterine infection, placental anomalies, twins, and refusal of consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No