- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848679
Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia
September 10, 2019 updated by: Hadassah Medical Organization
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel, 91120
- Hadassah Hebrew University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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Epidural 2% lidocaine, administered in 5mL incremental boluses.
Looking at dose-response effect.
5 x 5ml boluses of either epidural lidocaine 2% or epidural saline
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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
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Epidural 2% lidocaine, administered in 5mL incremental boluses.
Looking at dose-response effect.
5 x 5ml boluses of either epidural lidocaine 2% or epidural saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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15min after each dose - on a dose--response curve
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uterine artery pulsatility index (worse vessel)
Time Frame: 15 min after dose
|
15 min after dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Anticipated)
October 1, 2009
Study Completion (Anticipated)
October 1, 2009
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Eclampsia
- Pre-Eclampsia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- ACET3-ginosar-HMO-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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