The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
Summary
The objectives 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 confounders.
Hypothesis:
Patients who require a decrease in their basal labor analgesia epidural infusion rate will have an increased incidence of forceps delivery.
Description
The obstetrical anesthesia database will be queried for all forceps deliveries between the dates of January 2004 - January 2005. We anticipate that approximately 600 records of forceps delivery will be included. A matching cohort (equal number) of those having spontaneous vaginal deliveries will be examined. Subjects in the cohort group will be randomly chosen, matched for date of delivery and parity. The database will be queried for the following; maternal age, parity, gestational age, type of analgesia, changes in epidural infusion rate/ concentration, and supplemental bolus doses of local anesthesia. The data will be stripped of identification by the database manager Robert McCarthy (refer to attached letter) and entered into a secure 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. Variables will be compared using X2 and Mann-Whitney U test. A P< 0.05 will be required to reject the null hypothesis.
Study Design
Observational Model: Cohort, Time Perspective: Retrospective
Conditions
Labour
Intervention
Chart Review
Location
Northwestern University
Chicago
Illinois
United States
60611
Status
Completed
Source
Northwestern University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00443560
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:30:02-0400
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Review of the medical necessity of hospital or other health facility admissions, upon or within a short time following an admission, and periodic review of services provided during the course of treatment.
Drug Utilization Review
Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.
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Organizations representing designated geographic areas which have contracts under the PRO program to review the medical necessity, appropriateness, quality, and cost-effectiveness of care received by Medicare beneficiaries. Peer Review Improvement Act, PL 97-248, 1982.
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Published materials which provide an examination of recent or current literature. Review articles can cover a wide range of subject matter at various levels of completeness and comprehensiveness based on analyses of literature that may include research findings. The review may reflect the state of the art. It also includes reviews as a literary form.
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Review of claims by insurance companies to determine liability and amount of payment for various services. The review may also include determination of eligibility of the claimant or beneficiary or of the provider of the benefit; determination that the benefit is covered or not payable under another policy; or determination that the service was necessary and of reasonable cost and quality.
