Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction

This study has been completed.
Sponsor:
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00197340
First received: September 13, 2005
Last updated: July 14, 2008
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Pre-Eclampsia
Fetal Growth Retardation
Drug: Epidural ropivacaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Antepartum Chronic Epidural Therapy (ACET) Using Ropivacaine to Improve Uteroplacental Blood Flow in Pre-Eclampsia and Intrauterine Growth Restriction

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Uterine artery blood flow
  • Gestational age at delivery.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 20
Study Start Date: August 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Women with sonographic uterine artery flow abnormalities and either PE or IUGR (or both) were randomized to either ACET or non ACET control. Both groups were able to receive standard therapies (in-hospital monitoring, magnesium and anti-hypertensives as appropriate). The first five days of the therapeutic arm (ACET) consisted of a dose-finding trial, where epidural ropivacaine infusions (10ml/hr for 24 hours) of 0•04%, 0•06%, 0•08% and 0•1% and a saline placebo were each administered via tunneled epidural catheters in a randomized, double-blinded, cross-over design over five consecutive days; all three women received all doses. Doppler measurement of flow in the uterine artery was performed at baseline and at the end of each dose period. The ideal dose for an individual was determined to be lowest dose of drug giving maximal effect without side effects; in the second stage of the study, this dose was administered until delivery with the addition of a second placebo day to during this period.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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.

    2. 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.

    3. 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.

4b 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197340

Locations
Israel
Hadassah Hebrew University Medical Center, POB 12000
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
International Anesthesia Research Society (IARS)
Investigators
Principal Investigator: Yehuda Ginosar, BSc MBBS Hadassah Medical Organization
  More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00197340     History of Changes
Other Study ID Numbers: ACET1-ginosar-HMO-CTIL
Study First Received: September 13, 2005
Last Updated: July 14, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Pre-Eclampsia
Fetal Growth Retardation
Anesthesia, Epidural
Placental Circulation
Dose-Response Relationship, Drug

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Ropivacaine
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

ClinicalTrials.gov processed this record on October 19, 2014