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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00848679
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 19, 2009
February 19, 2009
March 2009
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Uterine artery pulsatility index (worse vessel) [ Time Frame: 15 min after dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigating the Novel Observation of Right-Left Difference in Uterine Artery Vascular Resistance in Pre-Eclampsia
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

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pre-Eclampsia
  • 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
  • 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.
    Interventions:
    • Drug: Epidural lidocaine
    • Drug: Epidural lidocaine 2%
  • 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
    Interventions:
    • Drug: Epidural lidocaine
    • Drug: Epidural lidocaine 2%
Ginosar Y, Nadjari M, Hoffman A, Firman N, Davidson EM, Weiniger CF, Rosen L, Weissman C, Elchalal U; the ACET study group. Antepartum continuous epidural ropivacaine therapy reduces uterine artery vascular resistance in pre-eclampsia: a randomized, dose-ranging, placebo-controlled study. Br J Anaesth. 2009 Mar;102(3):369-378. Epub 2009 Jan 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
No
Contact: Yehuda Ginosar, BSc MBBS +972-507-874388 yginosar@netvision.net.il
Contact: Uriel Elchalal, MD +972-507-874356 uriele@ekmd.huji.ac.il
Israel
 
NCT00848679
ACET3-ginosar-HMO-CTIL
No
Dr Yehuda Ginosar, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP