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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04940091
Other study ID # 2021-173
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)

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. — View Citation

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. Review. — View Citation

Boudou M, Teissèdre 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. French. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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 allClick 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
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