search
Back to results

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

Primary Purpose

Pre-eclampsia

Status
Withdrawn
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Epidural lidocaine
Epidural lidocaine 2%
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-eclampsia focused on measuring Pre-eclampsia, Pregnancy, Uteroplacental blood flow, Epidural, Anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Hebrew University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Epidural lidocaine

Epidural saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference.

Secondary Outcome Measures

Uterine artery pulsatility index (worse vessel)

Full Information

First Posted
February 19, 2009
Last Updated
September 10, 2019
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00848679
Brief Title
Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia
Keywords
Pre-eclampsia, Pregnancy, Uteroplacental blood flow, Epidural, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural lidocaine
Arm Type
Active Comparator
Arm Description
30 women to receive 5 x 5mL boluses of epidural lidocaine 2%. 10 pre-eclampsia, 10 term pregnancy, 10 non-pregnant.
Arm Title
Epidural saline
Arm Type
Placebo Comparator
Arm Description
30 women to receive 5 x 5 mL boluses of epidural saline. 10 pre-eclamptics, 10 normal term pregnancy, 10 non-pregnant
Intervention Type
Drug
Intervention Name(s)
Epidural lidocaine
Intervention Description
Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.
Intervention Type
Drug
Intervention Name(s)
Epidural lidocaine 2%
Intervention Description
5 x 5ml boluses of either epidural lidocaine 2% or epidural saline
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Uterine artery pulsatility index (worse vessel)
Time Frame
15 min after dose

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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: gestational age between 35 to 40 completed weeks uterine artery notching OR evidence of reduced uterine artery blood flow resting systolic pressure > 140mmHg or diastolic pressure > 90mmHg measured twice at least 6 hours apart 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: gestational age between 35 to 40 completed weeks 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.
Facility Information:
Facility Name
Hadassah Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
19176534
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs