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

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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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
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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
|
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
|
- 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 ]
- Uterine artery pulsatility index (worse vessel) [ Time Frame: 15 min after dose ]

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

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
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 | |
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 |
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 |