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
Recruitment status was Not yet recruiting
Sponsor:
Hadassah Medical Organization
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pre-Eclampsia |
Drug: Epidural lidocaine Drug: Epidural lidocaine 2% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Hadassah Medical Organization:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Uterine artery pulsatility index (worse vessel) [ Time Frame: 15 min after dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders 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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848679
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
Publications:
| Responsible Party: | Dr Yehuda Ginosar, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00848679 History of Changes |
| Other Study ID Numbers: | ACET3-ginosar-HMO-CTIL |
| Study First Received: | February 19, 2009 |
| Last Updated: | February 19, 2009 |
| Health Authority: | Israel: Ministry of Health |
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 Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013