The Effects of Combined Spinal Epidurals on Fever During Labor of First-Time Mothers

NCT00802646 | Withdrawn DMC

• 1 other identifier: 2008.
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the epidural of local anesthetics has an effect on fever that may occur in first time mothers during labor.

Conditions

Vaginal Delivery

Keywords

first-time mother; epidural request; vaginal childbirth

Outcome Measures

Primary Outcomes (1)

• temperature of mother

  time of delivery

Secondary Outcomes (1)

• neonatal APGAR, temperature and cord blood gas

  time of birth

Study Arms (2)

1

EXPERIMENTAL

When it is time for the epidural catheter, the mother will receive 2.5 mcg fentanyl spinally and then a bag of preservative-free normal saline will be administered through the epidural pump. When additional pain medication is requested, the mother will receive a known combined spinal epidural solution.

Drug: saline

2

ACTIVE COMPARATOR

When it is time for the epidural catheter, the mother will receive 2.5 mcg fentanyl spinally and then a bag of combined spinal epidural anesthetic through the epidural pump. When additional pain medication is requested, the mother will receive a known combined spinal epidural solution.

Drug: fentanyl/bupivacaine/epinephrine

Interventions

saline DRUG

intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested

Also known as: placebo

1

fentanyl/bupivacaine/epinephrine DRUG

intrathecal 0.125% fentanyl/bupivacaine/epinephrine, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested The mother will then receive a new bag of fentanyl/bupivacaine/epinephrine.

Also known as: combined spinal epidural

2

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• having first child (nulliparous)
• term pregnancy (\> 37 weeks)
• vertex presentation
• singleton gestation
• ability to provide informed consent
• request for analgesia for labor pain

You may not qualify if:

• birth of second or more child (multiparous)
• preterm pregnancy (\< 37 weeks)
• presentation other than vertex (ie. breech, transverse)
• diabetic
• admit temperature \> 99.5
• active drug/alcohol dependence
• active genital herpes infection
• allergy to anesthetics used

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Related Publications (18)

• Lieberman E, Eichenwald E, Mathur G, Richardson D, Heffner L, Cohen A. Intrapartum fever and unexplained seizures in term infants. Pediatrics. 2000 Nov;106(5):983-8. doi: 10.1542/peds.106.5.983.

  PMID: 11061764 BACKGROUND

• Lieberman E, Lang JM, Frigoletto F Jr, Richardson DK, Ringer SA, Cohen A. Epidural analgesia, intrapartum fever, and neonatal sepsis evaluation. Pediatrics. 1997 Mar;99(3):415-9. doi: 10.1542/peds.99.3.415.

  PMID: 9041298 BACKGROUND

• Yancey MK, Zhang J, Schwarz J, Dietrich CS 3rd, Klebanoff M. Labor epidural analgesia and intrapartum maternal hyperthermia. Obstet Gynecol. 2001 Nov;98(5 Pt 1):763-70. doi: 10.1016/s0029-7844(01)01537-x.

  PMID: 11704166 BACKGROUND

• Fusi L, Steer PJ, Maresh MJ, Beard RW. Maternal pyrexia associated with the use of epidural analgesia in labour. Lancet. 1989 Jun 3;1(8649):1250-2. doi: 10.1016/s0140-6736(89)92341-6.

  PMID: 2566791 BACKGROUND

• Leighton BL, Halpern SH. The effects of epidural analgesia on labor, maternal, and neonatal outcomes: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S69-77. doi: 10.1067/mob.2002.121813.

  PMID: 12011873 BACKGROUND

• Dashe JS, Rogers BB, McIntire DD, Leveno KJ. Epidural analgesia and intrapartum fever: placental findings. Obstet Gynecol. 1999 Mar;93(3):341-4. doi: 10.1016/s0029-7844(98)00415-3.

  PMID: 10074975 BACKGROUND

• Kaul B, Vallejo M, Ramanathan S, Mandell G. Epidural labor analgesia and neonatal sepsis evaluation rate: a quality improvement study. Anesth Analg. 2001 Oct;93(4):986-90. doi: 10.1097/00000539-200110000-00038.

  PMID: 11574370 BACKGROUND

• Goodlin RC, Chapin JW. Determinants of maternal temperature during labor. Am J Obstet Gynecol. 1982 May 1;143(1):97-103. doi: 10.1016/0002-9378(82)90689-5.

  PMID: 7081319 BACKGROUND

• Gleeson NC, Nolan KM, Ford MR. Temperature, labour, and epidural analgesia. Lancet. 1989 Oct 7;2(8667):861-2. doi: 10.1016/s0140-6736(89)93020-1. No abstract available.

  PMID: 2571778 BACKGROUND

• Grether JK, Nelson KB. Maternal infection and cerebral palsy in infants of normal birth weight. JAMA. 1997 Jul 16;278(3):207-11.

  PMID: 9218666 RESULT

• Impey L, Greenwood C, MacQuillan K, Reynolds M, Sheil O. Fever in labour and neonatal encephalopathy: a prospective cohort study. BJOG. 2001 Jun;108(6):594-7. doi: 10.1111/j.1471-0528.2001.00145.x.

  PMID: 11426893 RESULT

• Sharma SK, Alexander JM, Messick G, Bloom SL, McIntire DD, Wiley J, Leveno KJ. Cesarean delivery: a randomized trial of epidural analgesia versus intravenous meperidine analgesia during labor in nulliparous women. Anesthesiology. 2002 Mar;96(3):546-51. doi: 10.1097/00000542-200203000-00007.

  PMID: 11873026 RESULT

• Ramin SM, Gambling DR, Lucas MJ, Sharma SK, Sidawi JE, Leveno KJ. Randomized trial of epidural versus intravenous analgesia during labor. Obstet Gynecol. 1995 Nov;86(5):783-9. doi: 10.1016/0029-7844(95)00269-w.

  PMID: 7566849 RESULT

• Goetzl L, Cohen A, Frigoletto F Jr, Lang JM, Lieberman E. Maternal epidural analgesia and rates of maternal antibiotic treatment in a low-risk nulliparous population. J Perinatol. 2003 Sep;23(6):457-61. doi: 10.1038/sj.jp.7210967.

  PMID: 13679931 RESULT

• Goetzl L, Rivers J, Evans T, Citron DR, Richardson BE, Lieberman E, Suresh MS. Prophylactic acetaminophen does not prevent epidural fever in nulliparous women: a double-blind placebo-controlled trial. J Perinatol. 2004 Aug;24(8):471-5. doi: 10.1038/sj.jp.7211128.

  PMID: 15141263 RESULT

• Goetzl L, Zighelboim I, Badell M, Rivers J, Mastrangelo MA, Tweardy D, Suresh MS. Maternal corticosteroids to prevent intrauterine exposure to hyperthermia and inflammation: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2006 Oct;195(4):1031-7. doi: 10.1016/j.ajog.2006.06.012. Epub 2006 Jul 26.

  PMID: 16875647 RESULT

• Banerjee S, Cashman P, Yentis SM, Steer PJ. Maternal temperature monitoring during labor: concordance and variability among monitoring sites. Obstet Gynecol. 2004 Feb;103(2):287-93. doi: 10.1097/01.AOG.0000100155.85379.88.

  PMID: 14754697 RESULT

• Arkoosh VA, Palmer CM, Yun EM, Sharma SK, Bates JN, Wissler RN, Buxbaum JL, Nogami WM, Gracely EJ. A randomized, double-masked, multicenter comparison of the safety of continuous intrathecal labor analgesia using a 28-gauge catheter versus continuous epidural labor analgesia. Anesthesiology. 2008 Feb;108(2):286-98. doi: 10.1097/01.anes.0000299429.52105.e5.

  PMID: 18212574 RESULT

MeSH Terms

Interventions

Sodium Chloride; Fentanyl

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Melissa Russo, M.D.

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

US (1)