Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443560
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2007-03-02
Brief Title:
The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Retrospective Case-controlled Study of the Association Between Request to Discontinue Second Stage Labor Epidural Analgesia and Risk of Instrumental Vaginal Delivery
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The objective of this study will be to compare epidural infusion management specifically looking at infusion rate changes in patients who receive forceps deliveries versus normal spontaneous vaginal deliveries We will match patients based on time and date of delivery as well as parity in order to eliminate these variables as potential con-founders
We hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery
We hypothesize patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery
Detailed Description:
The obstetrical anesthesia database will be queried for all forceps deliveries between the dates of January 2004-October 2005 To minimize the influence of different anesthetic and obstetric care providers the control group consisted of parturients who has spontaneous vaginal deliveries SVD in the same 24 hour period who were case-matched for gravidity and parity Parturients with twin deliveries and fetal demise were not selected for either group
The database will be queried for the following maternal age parity gestational age type of analgesia changes in epidural infusion rate andor concentration and supplemental bolus doses of local anesthesia The data will be stripped of identification by the database manager and entered into a secured computer which is password protected and maintained in the Department of Anesthesiology The primary endpoint is to evaluate if decreasing the epidural infusion rate was associated with a forceps delivery
The database will be queried for the following maternal age parity gestational age type of analgesia changes in epidural infusion rate andor concentration and supplemental bolus doses of local anesthesia The data will be stripped of identification by the database manager and entered into a secured computer which is password protected and maintained in the Department of Anesthesiology The primary endpoint is to evaluate if decreasing the epidural infusion rate was associated with a forceps delivery
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