drugset / Trial / NCT00802646
The Effects of Combined Spinal Epidurals on Fever During Labor of First-Time Mothers
Withdrawn
Ochsner Health System
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2009-06
- Primary completion
- 2010-06
- Completion
- 2010-06
Outcome
Outcome not reported
Stopped: “study moved to alternate site”
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Results Grether JK, Nelson KB. Maternal infection and cerebral palsy in infants of normal birth weight. JAMA. 1997 Jul 16;278(3):207-11.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | — | Intrathecal |
| Comparator | Epinephrine | Other / unclassified | — | Intrathecal |
| Comparator | Fentanyl | Other / unclassified | — | Intrathecal |
Indications
No indication recorded.