Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197340
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
2005-09-13
Brief Title:
Antepartum Chronic Epidural Therapy ACET to Improve Blood Flow to the Uterus Placenta and Baby in Pre-Eclampsia and Intrauterine Growth Restriction
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Antepartum Chronic Epidural Therapy ACET Using Ropivacaine to Improve Uteroplacental Blood Flow in Pre-Eclampsia and Intrauterine Growth Restriction
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10mlhr for 24 hours of 004 006 008 and 01 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None