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

NCT00848679 | Withdrawn Phase 3

• 1 other identifier: ACET3-ginosar-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Pre-eclampsia

Keywords

Pre-eclampsia; Pregnancy; Uteroplacental blood flow; Epidural; Anesthesia

Outcome Measures

Primary Outcomes (1)

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

  15min after each dose - on a dose--response curve

Secondary Outcomes (1)

• Uterine artery pulsatility index (worse vessel)

  15 min after dose

Study Arms (2)

Epidural lidocaine

ACTIVE COMPARATOR

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

Drug: Epidural lidocaine; Drug: Epidural lidocaine 2%

Epidural saline

PLACEBO COMPARATOR

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; Drug: Epidural lidocaine 2%

Interventions

Epidural lidocaine DRUG

Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.

Epidural lidocaine; Epidural saline

Epidural lidocaine 2% DRUG

5 x 5ml boluses of either epidural lidocaine 2% or epidural saline

Epidural lidocaine; Epidural saline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Related Publications (1)

• 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.

  PMID: 19176534 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 12, 2019

Record last verified: 2009-02

Locations

IL (1)