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
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 |
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.
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. |
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 |
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 |
China,
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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT03706599 -
Fever Infants and Therapeutic Education in Emergency Department
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT01782183 -
Thermographic Characteristics of Sore Throat by Thermographic Camera
|
N/A | |
Withdrawn |
NCT00800696 -
Preventive Oral Care
|
N/A | |
Completed |
NCT02689193 -
IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
|
||
Completed |
NCT02212990 -
The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine
|
N/A | |
Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
Completed |
NCT01869699 -
Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults
|
Phase 4 | |
Completed |
NCT01559675 -
Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery
|
N/A | |
Completed |
NCT01194557 -
Introducing Rapid Diagnostic Tests Into the Private Health Sector
|
N/A | |
Completed |
NCT00969176 -
Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT00940654 -
The Fever and Antipyretic in Critically Illness Evaluation Study
|
N/A | |
Recruiting |
NCT00729976 -
Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.
|
Phase 4 | |
Recruiting |
NCT00389272 -
Adding a Second Drug for Febrile Children Treated With Acetaminophen
|
N/A | |
Completed |
NCT00257790 -
The Tobramycin Study
|
Phase 4 | |
Recruiting |
NCT05033613 -
Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
|
||
Completed |
NCT02595827 -
Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo
|
Phase 3 | |
Recruiting |
NCT06061575 -
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients
|
Phase 4 | |
Recruiting |
NCT06038617 -
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
|
Phase 4 |