NCT00197340

Brief Summary

Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are common and important disorders of pregnancy. Both disorders are associated with an impairment of uteroplacental blood flow (UPBF). No effective therapy has been identified to reliably improve UPBF in these patients and typically, obstetric management involves interventional delivery, particularly problematic when remote from term. This study assess the hypothesis that epidural local anesthetics may improve UPBF in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 15, 2008

Status Verified

February 1, 2006

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

July 14, 2008

Conditions

Pre-EclampsiaFetal Growth Retardation

Keywords

Pre-EclampsiaFetal Growth RetardationAnesthesia, EpiduralPlacental CirculationDose-Response Relationship, Drug

Outcome Measures

Primary Outcomes (2)

  • Uterine artery blood flow

  • Gestational age at delivery.

Secondary Outcomes (5)

  • Ductus venosus and MCA blood flow

  • Proprioceptive loss;

  • Maternal hemodynamic changes;

  • Fetal weight (throughout pregnancy and at delivery); amniotic fluid index;

  • obstetric outcome (maternal mortality, morbidity, neonatal mortality, morbidity, mode of delivery, obstetric complications).

Interventions

Epidural ropivacaineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Reliable gestational age based upon an ultrasound crown-rump length performed between 7 to 14 completed weeks gestation. If the ultrasound date matches the date of the last menstrual period (LMP) within 7 days, the LMP date is used, otherwise the ultrasound date is used.
  • \. Gestational age at the time of enrollment between 28 to 32 weeks (based upon 1.) and need for in-hospital observation or treatment REGARDLESS of the study.
  • \. Presence of uterine artery notching in ultrasound scan. 4. EITHER 4a or 4b (if both, the patient is enrolled as for 4a): 4a. Pre-eclampsia: Women must have criteria #1 and #2 Criterion #1: Hypertension (\> 140/90) at rest, measured twice, at least 6 hours apart.
  • Criterion #2: Proteinuria:
  • EITHER: 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.
  • b Intrauterine growth retardation (IUGR): Women must have criteria #1 and #2. Criterion #1: Ultrasound abdominal circumference below 10th percentile. Criterion #2: Established IUGR for at least 2 weeks.

You may not qualify if:

  • at the time of enrollment: active labor, severe pre-eclampsia, (resting blood pressure ≥ 160mmHg systolic or 110 diastolic, recorded on at least two occasions 6 hours apart), known fetal anomaly, intrauterine infection, placental anomalies (previa, abruption, circumvallate, infarction), twins, and refusal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center, POB 12000

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: 19176534DERIVED

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yehuda Ginosar, BSc MBBS

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

July 15, 2008

Record last verified: 2006-02

Locations

IL(1)