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|---|---|---|---|
| 2008. |
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study moved to alternate site
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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.
Intrapartum fever (fever during labor) is a real and potentially devastating problem. Infants delivered at term who have been exposed to the mother having a fever during labor have a >9 fold increased risk of cerebral palsy. Studies have also shown an increased risk of neonatal encephalopathy associated with fever during labor. Maternal fever in the absence of infection is associated with a 4 fold increased risk of neonatal hypoxic encephalopathy and 3.4 fold increased risk of unexplained neonatal seizures.
The likely role of inflammatory mediators in the process of maternal fever (temperature >100.4), regardless of etiology, makes it important to further investigational studies in an effort to discover the etiology of intrapartum fever associated with epidural analgesia. If an inflammatory trigger (i.e., the injection of epidural local anesthetics) can be identified or delayed, then the risks of maternal hyperthermia can be minimized and/ or eliminated.
The greatest risk of fever with epidural labor analgesia is seen in women having their first child. This is the same population associated with prolonged labor. Although intrapartum fever has a very low incidence overall, 11-33% of first-time mothers will eventually develop fever >100.4 during epidural analgesia. Although the degree of rise in temperature occurs very slowly, it has been shown to be significant enough to cause increased neonatal sepsis workup and antibiotic coverage for both the mother and the neonate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline | Drug | intrathecal preservative free normal saline, 8ml/hour, beginning after intrathecal sufentanyl until additional pain medication is requested |
|
| Measure | Description | Time Frame |
|---|---|---|
| temperature of mother | time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal APGAR, temperature and cord blood gas | time of birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Russo, M.D. | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11061764 | 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. | |
| 9041298 | 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. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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. |
|
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| 11704166 | 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. |
| 2566791 | 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. |
| 12011873 | 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. |
| 10074975 | 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. |
| 11574370 | 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. |
| 7081319 | 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. |
| 2571778 | 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. |
| 9218666 | Result | Grether JK, Nelson KB. Maternal infection and cerebral palsy in infants of normal birth weight. JAMA. 1997 Jul 16;278(3):207-11. |
| 11426893 | 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. |
| 11873026 | 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. |
| 7566849 | 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. |
| 13679931 | 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. |
| 15141263 | 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. |
| 16875647 | 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. |
| 14754697 | 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. |
| 18212574 | 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. |
| D017670 |
| Sodium Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |