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

Pre-eclampsia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00848679
• Other study ID #: ACET3-ginosar-HMO-CTIL
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: February 2009
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Epidural lidocaine
Epidural 2% lidocaine, administered in 5mL incremental boluses. Looking at dose-response effect.
• Epidural lidocaine 2%
5 x 5ml boluses of either epidural lidocaine 2% or epidural saline

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine artery pulsatility index (by Doppler ultrasound). Specifically the right-left uterine artery difference.		15min after each dose - on a dose--response curve
Secondary	Uterine artery pulsatility index (worse vessel)		15 min after dose