Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
1051 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-06-10
Study Completion Date
2022-03-21
Brief Summary
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Women who receive epidural analgesia during labor are more likely to develop fever than those who do not. Maternal fever during labor can produce various harmful effects on both mothers and infants. The investigators speculate that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.
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Detailed Description
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Epidural related maternal fever (ERMF) refers to the phenomenon of increased body temperature of parturient after receiving epidural analgesia during labor. Women who receive epidural labor analgesia are more likely to have fever than those who do not. In a systematic review, 20-33% of parturients receiving neuraxial analgesia developed fever during labor, compared with only 5-7% of those without neuraxial analgesia. Maternal fever can interfere with women's laboring process, decrease the sensitivity of the uterus and cervix to oxytocin, and lead to dystocia and increased surgical delivery rate. The investigators note that the rate of ERMF is lower in patients receiving lower density neuraxial blockade. The study is designed to test the hypothesis that the effect of epidural analgesia is associated with the development of maternal fever, i.e., better analgesia is associated with higher risk of maternal fever.
Conditions
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Epidural Analgesia
Analgesic Effect
Fever
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Epidural labor analgesia
All participants will receive epidural analgesia during labor.
Epidural analgesia
Intervention Type
DRUG
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
Interventions
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Epidural analgesia
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
Intervention Type
DRUG
Other Intervention Names
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No other intervention
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old;
* Nulliparae with single term cephalic pregnancy;
* Preparing to give vaginal delivery under epidural analgesia.
* Nulliparae with single term cephalic pregnancy;
* Preparing to give vaginal delivery under epidural analgesia.
Exclusion Criteria
* Basal body temperature ≥37.3°C;
* Presence of serious pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP \[Hemolysis, Elevated Liver enzymes, Low Platelet count\] syndrome, placenta previa, abruption of placenta, or hyperthyroidism);
* History of hyperthyrodism, including hyperthyrodism in pregnancy;
* Taking sedatives and/or analgesics within one week before planned delivery;
* American Society of Anesthesiologists classification \>class III;
* Contraindications to epidural puncture, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as intraspinal mass, lumbar disc herniation, history of spinal trauma, etc.), abnormal blood coagulation, etc.;
* Presence of infections, including obstetric infections, systemic infections (such as sepsis, bacteremia), or infections at the puncture site or adjacent sites;
* Other conditions that are considered unsuitable for study participation;
* Refused to participate in the study.
* Presence of serious pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP \[Hemolysis, Elevated Liver enzymes, Low Platelet count\] syndrome, placenta previa, abruption of placenta, or hyperthyroidism);
* History of hyperthyrodism, including hyperthyrodism in pregnancy;
* Taking sedatives and/or analgesics within one week before planned delivery;
* American Society of Anesthesiologists classification \>class III;
* Contraindications to epidural puncture, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as intraspinal mass, lumbar disc herniation, history of spinal trauma, etc.), abnormal blood coagulation, etc.;
* Presence of infections, including obstetric infections, systemic infections (such as sepsis, bacteremia), or infections at the puncture site or adjacent sites;
* Other conditions that are considered unsuitable for study participation;
* Refused to participate in the study.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Guangdong Women and Children Hospital
OTHER
Sponsor Role
collaborator
Tangshan Maternal and Child Health Hospital
OTHER
Sponsor Role
collaborator
Dongguan Maternal and Child Health Hospital
UNKNOWN
Sponsor Role
collaborator
Beijing Haidian Maternal and Child Health Hospital
OTHER
Sponsor Role
collaborator
Beijing Fuxing Hospital
UNKNOWN
Sponsor Role
collaborator
The Fourth Hospital of Shijiazhuang
OTHER
Sponsor Role
collaborator
Xiamen Maternity & Child Care Hospital
OTHER
Sponsor Role
collaborator
Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Xiamen maternal and child hospital
Xiamen, Fujian, China
Site Status
Dongguan women and children's hospital
Dongguan, Guangdong, China
Site Status
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Site Status
Shijiazhuang Obstetric and Gynecology Hospital
Shijiazhuang, Hebei, China
Site Status
Tangshan maternal and child hospital
Tangshan, Hebei, China
Site Status
Beijing Fuxing Hospital
Beijing, , China
Site Status
Beijing Haidian women and children's Hospital
Beijing, , China
Site Status
Countries
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China
References
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Arendt KW, Segal BS. The association between epidural labor analgesia and maternal fever. Clin Perinatol. 2013 Sep;40(3):385-98. doi: 10.1016/j.clp.2013.06.002. Epub 2013 Jul 19.
Reference Type
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.
Reference Type
BACKGROUND
Camann WR, Hortvet LA, Hughes N, Bader AM, Datta S. Maternal temperature regulation during extradural analgesia for labour. Br J Anaesth. 1991 Nov;67(5):565-8. doi: 10.1093/bja/67.5.565.
Reference Type
BACKGROUND
Lucas MJ, Sharma SK, McIntire DD, Wiley J, Sidawi JE, Ramin SM, Leveno KJ, Cunningham FG. A randomized trial of labor analgesia in women with pregnancy-induced hypertension. Am J Obstet Gynecol. 2001 Oct;185(4):970-5. doi: 10.1067/mob.2001.117970.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sharma SK, Sidawi JE, Ramin SM, Lucas MJ, Leveno KJ, Cunningham FG. Cesarean delivery: a randomized trial of epidural versus patient-controlled meperidine analgesia during labor. Anesthesiology. 1997 Sep;87(3):487-94. doi: 10.1097/00000542-199709000-00006.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sharpe EE, Arendt KW. Epidural Labor Analgesia and Maternal Fever. Clin Obstet Gynecol. 2017 Jun;60(2):365-374. doi: 10.1097/GRF.0000000000000270.
Reference Type
BACKGROUND
Kovo M, Schreiber L, Ben-Haroush A, Shor S, Golan A, Bar J. Intrapartum fever at term: clinical characteristics and placental pathology. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1273-7. doi: 10.3109/14767058.2011.629248. Epub 2011 Nov 4.
Reference Type
BACKGROUND
Perlman JM. Maternal fever and neonatal depression: preliminary observations. Clin Pediatr (Phila). 1999 May;38(5):287-91. doi: 10.1177/000992289903800506.
Reference Type
BACKGROUND
Burgess APH, Katz JE, Moretti M, Lakhi N. Risk Factors for Intrapartum Fever in Term Gestations and Associated Maternal and Neonatal Sequelae. Gynecol Obstet Invest. 2017;82(5):508-516. doi: 10.1159/000453611. Epub 2017 Jan 20.
Reference Type
BACKGROUND
Dior UP, Kogan L, Calderon-Margalit R, Burger A, Amsallem H, Elchalal U, Eventov-Friedman S, Ergaz Z, Ezra Y. The association of maternal intrapartum subfebrile temperature and adverse obstetric and neonatal outcomes. Paediatr Perinat Epidemiol. 2014 Jan;28(1):39-47. doi: 10.1111/ppe.12090. Epub 2013 Oct 10.
Reference Type
BACKGROUND
Dior UP, Kogan L, Eventov-Friedman S, Gil M, Bahar R, Ergaz Z, Porat S, Calderon-Margalit R. Very High Intrapartum Fever in Term Pregnancies and Adverse Obstetric and Neonatal Outcomes. Neonatology. 2016;109(1):62-8. doi: 10.1159/000440938. Epub 2015 Nov 5.
Reference Type
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.
Reference Type
BACKGROUND
Abdullahi H, Satti M, Rayis DA, Imam AM, Adam I. Intra-partum fever and cerebral palsy in Khartoum, Sudan. BMC Res Notes. 2013 Apr 24;6:163. doi: 10.1186/1756-0500-6-163.
Reference Type
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.
Reference Type
BACKGROUND
Glosten B, Savage M, Rooke GA, Brengelmann GL. Epidural anesthesia and the thermoregulatory responses to hyperthermia--preliminary observations in volunteer subjects. Acta Anaesthesiol Scand. 1998 Apr;42(4):442-6. doi: 10.1111/j.1399-6576.1998.tb05139.x.
Reference Type
BACKGROUND
Goetzl L. Epidural analgesia and maternal fever: a clinical and research update. Curr Opin Anaesthesiol. 2012 Jun;25(3):292-9. doi: 10.1097/ACO.0b013e3283530d7c.
Reference Type
BACKGROUND
Segal S. Labor epidural analgesia and maternal fever. Anesth Analg. 2010 Dec;111(6):1467-75. doi: 10.1213/ANE.0b013e3181f713d4. Epub 2010 Sep 22.
Reference Type
BACKGROUND
Chen X, Ni X, Zhang Y, Liu H, Liu Z. The association of labor epidural analgesia with low concentration of ropivacaine and maternal fever: A retrospective study. J Clin Anesth. 2020 Oct;65:109613. doi: 10.1016/j.jclinane.2019.09.007. Epub 2020 May 15. No abstract available.
Reference Type
BACKGROUND
Zhou X, Li J, Deng S, Xu Z, Liu Z. Ropivacaine at different concentrations on intrapartum fever, IL-6 and TNF-alpha in parturient with epidural labor analgesia. Exp Ther Med. 2019 Mar;17(3):1631-1636. doi: 10.3892/etm.2018.7121. Epub 2018 Dec 20.
Reference Type
BACKGROUND
Wang T, Lu Y, Zhou P, Huang S, Yu X. A Randomized Controlled Comparison of Epidural Analgesia Onset Time and Adverse Reactions During Labor With Different Dose Combinations of Bupivacaine and Sufentanil. Clin J Pain. 2020 Aug;36(8):612-617. doi: 10.1097/AJP.0000000000000837.
Reference Type
BACKGROUND
Boudou M, Teissedre F, Walburg V, Chabrol H. [Association between the intensity of childbirth pain and the intensity of postpartum blues]. Encephale. 2007 Oct;33(5):805-10. doi: 10.1016/j.encep.2006.10.002. French.
Reference Type
BACKGROUND
Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
Reference Type
BACKGROUND
Suhitharan T, Pham TP, Chen H, Assam PN, Sultana R, Han NL, Tan EC, Sng BL. Investigating analgesic and psychological factors associated with risk of postpartum depression development: a case-control study. Neuropsychiatr Dis Treat. 2016 Jun 9;12:1333-9. doi: 10.2147/NDT.S105918. eCollection 2016.
Reference Type
BACKGROUND
Liu ZH, He ST, Deng CM, Ding T, Xu MJ, Wang L, Li XY, Wang DX. Neuraxial labour analgesia is associated with a reduced risk of maternal depression at 2 years after childbirth: A multicentre, prospective, longitudinal study. Eur J Anaesthesiol. 2019 Oct;36(10):745-754. doi: 10.1097/EJA.0000000000001058.
Reference Type
BACKGROUND
Other Identifiers
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2021-173
Identifier Type: -
Identifier Source: org_study_id
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