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Completed

NCT Number: NCT00443560

The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singletons
  • Viable fetal vaginal deliveries between January 2004-October 2005

Exclusion criteria

  • Outside specified time frame
  • Multiparity
  • Fetal demise

Treatment and study plan

Case controlled analysis of epidural labor analgesia patterns

Other

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: combined spinal epidural analgesia, epidural labor analgesia, bupivacaine, fentanyl

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Number of Participants With Breakthrough Pain in the First Stage of Labor

    Time frame: Supplemental analgesia in first stage of labor (<24 hours)

    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.

  2. Duration of Labor Analgesia

    Time frame: Time form initiation of labor analgesia to delivery (up to 24 hours)

    Time in minutes from initiation of labor analgesia until delivery of the infant

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

A Retrospective Case-controlled Study of the Association Between Request to Discontinue Second Stage Labor Epidural Analgesia and Risk of Instrumental Vaginal Delivery

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 6, 2007
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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