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

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ClinicalTrials.gov Identifier: NCT00197340
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 15, 2008
Sponsor:
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date July 15, 2008
Study Start Date  ICMJE August 2003
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Uterine artery blood flow
  • Gestational age at delivery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antepartum Chronic Epidural Therapy (ACET) to Improve Blood Flow to the Uterus, Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction
Official Title  ICMJE Antepartum Chronic Epidural Therapy (ACET) Using Ropivacaine to Improve Uteroplacental Blood Flow in Pre-Eclampsia and Intrauterine Growth Restriction
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pre-Eclampsia
  • Fetal Growth Retardation
Intervention  ICMJE Drug: Epidural ropivacaine
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00197340
Other Study ID Numbers  ICMJE ACET1-ginosar-HMO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE International Anesthesia Research Society (IARS)
Investigators  ICMJE
Principal Investigator: Yehuda Ginosar, BSc MBBS Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP