AzTrials
AzTrials

Labor PainNCT00443560

The Association Between Decreasing Labor Analgesia Epidural Infusion and Forceps Delivery

An observational study of Labor Pain and Pregnancy, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain, Pregnancy
Type of treatment
Injection or infusion
How many people
2,162 participants
Where
1 siteUnited States
Study dates
Jan 2006to Mar 2006
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Pregnant Women

Who may be able to join

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

Who cannot join

  • Outside specified time frame
  • Multiparity
  • Fetal demise

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Case controlled analysis of epidural labor analgesia patterns
Keywords
Labor, Epidural Analgesia, delivery, vacuum extraction, obstetrical Forceps
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case controlled analysis of epidural labor analgesia patternsOther

    Also called combined spinal epidural analgesia, epidural labor analgesia, bupivacaine, fentanyl

    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

Study groups in NCT00443560
Study groupRoleWhat they receive
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.
Receives: Other: Case controlled analysis of epidural labor analgesia patterns
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.
Receives: Other: Case controlled analysis of epidural labor analgesia patterns

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Parturients With a Decrease in the Infusion of Epidural Analgesia During Second Stage of Labor

    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.

    Measured: Second stage of labor up to 3 hours

Secondary outcomes (2)

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

    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.

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

  2. Duration of Labor Analgesia

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2007 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
2,162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00443560
Sponsor's protocol ID
0524-028
Status last verified
Mar 2014
First submitted
2 Mar 2007
Last updated
14 Apr 2014
Data monitoring committee
No

Publications

  • Murphy DJ. Failure to progress in the second stage of labour. Curr Opin Obstet Gynecol. 2001 Dec;13(6):557-61. doi: 10.1097/00001703-200112000-00002.

    PubMed 11707657

  • Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.

    PubMed 11454372

  • Torvaldsen S, Roberts CL, Bell JC, Raynes-Greenow CH. Discontinuation of epidural analgesia late in labour for reducing the adverse delivery outcomes associated with epidural analgesia. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004457. doi: 10.1002/14651858.CD004457.pub2.

    PubMed 15495111

  • Hess PE, Pratt SD, Soni AK, Sarna MC, Oriol NE. An association between severe labor pain and cesarean delivery. Anesth Analg. 2000 Apr;90(4):881-6. doi: 10.1097/00000539-200004000-00020.

    PubMed 10735793

  • Cohen SE, Yeh JY, Riley ET, Vogel TM. Walking with labor epidural analgesia: the impact of bupivacaine concentration and a lidocaine-epinephrine test dose. Anesthesiology. 2000 Feb;92(2):387-92. doi: 10.1097/00000542-200002000-00019.

    PubMed 10691224

  • Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63. doi: 10.1097/00000542-200304000-00024.

    PubMed 12657859

  • Yancey MK, Zhang J, Schweitzer DL, Schwarz J, Klebanoff MA. Epidural analgesia and fetal head malposition at vaginal delivery. Obstet Gynecol. 2001 Apr;97(4):608-12. doi: 10.1016/s0029-7844(00)01230-8.

    PubMed 11275036

  • Wong CA, Scavone BM, Peaceman AM, McCarthy RJ, Sullivan JT, Diaz NT, Yaghmour E, Marcus RJ, Sherwani SS, Sproviero MT, Yilmaz M, Patel R, Robles C, Grouper S. The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med. 2005 Feb 17;352(7):655-65. doi: 10.1056/NEJMoa042573.

    PubMed 15716559

  • 9. Wong CA, Scavone BM, Sullivan JT, Ebarvia MJ, McCarthy RJ. The risk of cesarean delivery with early neuraxial analgesia in nulliparous induction of labor. http://www.asa-abstracts.com 2007:A1204.

  • Ben-Haroush A, Melamed N, Kaplan B, Yogev Y. Predictors of failed operative vaginal delivery: a single-center experience. Am J Obstet Gynecol. 2007 Sep;197(3):308.e1-5. doi: 10.1016/j.ajog.2007.06.051.

    PubMed 17826432

  • Ziadeh S, Yahaya A. Pregnancy outcome at age 40 and older. Arch Gynecol Obstet. 2001 Mar;265(1):30-3. doi: 10.1007/s004040000122.

    PubMed 11327090

Questions about this trial

What is this clinical trial studying?

An observational study of Labor Pain and Pregnancy, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443560, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in