The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Labor Pain Pregnancy |
Other: Case controlled analysis of epidural labor analgesia patterns |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| 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 |
- Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor [ Time Frame: Second stage of labor up to 3 hours ] [ Designated as safety issue: No ]At the request of the obstetric provider, second stage analgesia density was decreased by decreasing the basal infusion rate if there was dissatisfaction with the progress of labor or a perceived inability to push. The basal infusion was never totally discontinued.
- Number of Participants With Breakthrough Pain in the First Stage of Labor [ Time Frame: Supplemental analgesia in first stage of labor (<24 hours) ] [ Designated as safety issue: No ]Pain not responding to epidural analgesia in the first stage of labor was treated with bolus dose of bupivacaine 1.25 mg/mL or lidocaine 10 mg/mL, 10 to 15 mL. If pain relief was obtained the infusion concentration was increased. If the patient had no pain relief following the bolus injection, the epidural catheter was replaced.
- Duration of Labor Analgesia [ Time Frame: Time form initiation of labor analgesia to delivery (up to 24 hours) ] [ Designated as safety issue: No ]Time in minutes from initiation of labor analgesia until delivery of the infant
| Enrollment: | 2162 |
| Study Start Date: | January 2006 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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Instrumental Vaginal Delivery (IVD)
Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
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Other: Case controlled analysis of epidural labor analgesia patterns
A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Other Names:
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Spontaneous Vaginal Delivery (SVD)
The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
|
Other: Case controlled analysis of epidural labor analgesia patterns
A retrospective study utilizing the Obstetric Anesthesiology Database to identify parturients who received neuraxial labor analgesia initiated with a combined spinal epidural (CSE) technique and maintained with a continuous epidural infusion with patient controlled epidural analgesia boluses
Other Names:
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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 and/or 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Pregnant Women
Inclusion Criteria:
- Singletons
- Viable fetal vaginal deliveries between January 2004-October 2005
Exclusion Criteria:
- Outside specified time frame
- Multiparity
- Fetal demise
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
More Information
Publications:
| Responsible Party: | Cynthia A. Wong M.D., Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00443560 History of Changes |
| Other Study ID Numbers: | 0524-028 |
| Study First Received: | March 2, 2007 |
| Results First Received: | May 9, 2011 |
| Last Updated: | June 22, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Labor Epidural Analgesia delivery vacuum extraction obstetrical Forceps |
Additional relevant MeSH terms:
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Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013