Overview

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

Status:
Withdrawn
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hadassah Medical Organization
Treatments:
Lidocaine
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:

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.