Epidural Analgesia and Maternal Fever During Labor

Fever Clinical Trial

Official title:

Association Between the Effect of Epidural Analgesia and the Development of Maternal Fever During Labor: a Multicenter, Prospective, Observational, Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940091
• Other study ID #: 2021-173
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Peking University First Hospital
• Contact: Shuo Wang, MD
• Phone: 86 13521869490
• Email: 13521869490[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old;
• Nulliparae with single term cephalic pregnancy;
• Preparing to give vaginal delivery under epidural analgesia.

Exclusion Criteria:

• Basal body temperature =37.3?;
• 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.

Related Conditions & MeSH terms

• Epidural Analgesia
• Fever

Intervention

Drug:
• Epidural analgesia
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).

Locations

Country	Name	City	State
China	Beijing Fuxing Hospital	Beijing
China	Beijing Haidian women and children's Hospital	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Dongguan women and children's hospital	Dongguan	Guangdong
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Shijiazhuang Obstetric and Gynecology Hospital	Shijiazhuang	Hebei
China	Tangshan maternal and child hospital	Tangshan	Hebei
China	Xiamen maternal and child hospital	Xiamen	Fujian

Sponsors (8)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Fuxing Hospital, Beijing Haidian Maternal and Child Health Hospital, Dongguan Maternal and Child Health Hospital, Fourth Hospital of Shijiazhuang City, Guangdong Women and Children Hospital, Tangshan Maternal and Child Health Hospital, Xiamen Maternity & Child Care Hospital

Country where clinical trial is conducted

China, 

References & Publications (26)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. Review. — View Citation

Goodlin RC, Chapin JW. Determinants of maternal temperature during labor. Am J Obstet Gynecol. 1982 May 1;143(1):97-103. — View Citation

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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. — View Citation

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. — View Citation

Perlman JM. Maternal fever and neonatal depression: preliminary observations. Clin Pediatr (Phila). 1999 May;38(5):287-91. — View Citation

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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. Review. — View Citation

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. — View Citation

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. — View Citation

Sharpe EE, Arendt KW. Epidural Labor Analgesia and Maternal Fever. Clin Obstet Gynecol. 2017 Jun;60(2):365-374. doi: 10.1097/GRF.0000000000000270. — View Citation

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. — View Citation

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. — View Citation

Zhou X, Li J, Deng S, Xu Z, Liu Z. Ropivacaine at different concentrations on intrapartum fever, IL-6 and TNF-a 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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of maternal fever during labor	Maternal fever is defined as temperature of =38? during any stage of labor.	delivery ( the end of childbirth.)
Secondary	Occurrence of mild maternal fever during labor	Mild maternal fever is defined as temperature of >37.5? during any stage of labor.	delivery ( the end of childbirth.)
Secondary	Duration of labor	Duration of the first, second, and third stage of labor.	delivery ( the end of childbirth.)
Secondary	Neonatal Apgar score	Apgar score is assessed at 1 and 5 minutes after birth.	At 1 and 5 minutes after birth.
Secondary	Postpartum hospital stay	Postpartum hospital stay	Up to 42 days after childbirth.
Secondary	Postpartum pain intensity	Pain intensity is assessed with numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain).	At 1, 10 and 42 days after childbirth
Secondary	Postpartum breastfeeding	The status of breastfeeding include breastfeeding, formula milk, or a mix of them.	At 1, 10 and 42 days after childbirth
Secondary	Postpartum persistent pain	Defined as NRS pain score =1 that persisted since childbirth. For those with persistent pain, also ask if the following activities was affected, including walking, mood, sleep or concentration, as judged by parturients themselves.	At 42 days after childbirth
Secondary	Postpartum depression score	Postpartum depression is assessed with the the Edinburgh Postnatal Depression Scale. This is a 10-item self-report questionnaire; each item is rated from 0 to 3 denoting the increasing severity of symptoms, resulting in a maximum score of 30. A score =10 is defined as the presence of depression.	At 10 and 42 days postpartum
Secondary	Postpartum complications	Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention.	Up to 42 days postpartum