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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ginosar Y, Nadjari M, Hoffman A, Firman N, Davidson EM, Weiniger CF, Rosen L, Weissman C, Elchalal U; 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):369-78. doi: 10.1093/bja/aen402. Epub 2009 Jan 27.

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
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