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Investigating the Novel Observation of Right-Left Difference in Uterine Artery Vascular Resistance in Pre-Eclampsia

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ClinicalTrials.gov Identifier: NCT00848679
Recruitment Status : Unknown
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Epidural lidocaine Drug: Epidural lidocaine 2% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Novel Observation of Right-Left Difference in Uterine Artery Vascular Resistance in Pre-Eclampsia: A Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Dose-Dependent Effect of Epidural Lidocaine on Right-Left Uterine Artery Blood Flow Differences in Pre-Eclampsia, With Healthy Term Pregnant and Non-Pregnant Controls
Study Start Date : March 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Epidural lidocaine
30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant.
 Drug: Epidural lidocaine
Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

Drug: Epidural lidocaine 2%
5 x 5ml boluses of either epidural lidocaine 2% or epidural saline
Placebo Comparator: Epidural saline
30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant
 Drug: Epidural lidocaine
Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

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


Outcome Measures
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Primary Outcome Measures :
  1. Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference. [ Time Frame: 15min after each dose - on a dose--response curve ]

Secondary Outcome Measures :
  1. Uterine artery pulsatility index (worse vessel) [ Time Frame: 15 min after dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848679


Contacts
Contact: Yehuda Ginosar, BSc MBBS +972-507-874388 yginosar@netvision.net.il
Contact: Uriel Elchalal, MD +972-507-874356 uriele@ekmd.huji.ac.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Yehuda Ginosar, BSc MBBS    +972-507-874388    yginosar@netvision.net.il   
Contact: Uriel Elchalal, MD    +972-507-874356    uriele@ekmd.huji.ac.il   
Principal Investigator: Yehuda Ginosar, BSc MBBS         
Sub-Investigator: Uriel Elchalal, MD         
Sub-Investigator: Michel Nadjari, MD         
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Publications:

Responsible Party: Dr Yehuda Ginosar, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00848679     History of Changes
Other Study ID Numbers: ACET3-ginosar-HMO-CTIL
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Hadassah Medical Organization:
Pre-eclampsia
Pregnancy
Uteroplacental blood flow
Epidural
Anesthesia

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action