AzTrials
AzTrials

Epidural AnalgesiaNCT04940091

Epidural Analgesia and Maternal Fever During Labor

An observational study of Epidural Analgesia and Analgesic Effect, run by Peking University First Hospital at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epidural Analgesia, Analgesic Effect, Fever
What is being tested?
Epidural analgesia
How many people
1,051 participants
Where
8 sitesChina
Study dates
10 Jun 2021to 21 Mar 2022
How long will I take part?
42 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult (≥18 years old) nulliparae with single term cephalic pregnancy preparing to give vaginal delivery under epidural analgesia.

Who may be able to join

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

Who cannot join

  • 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.;
Show all 9Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Fuxing Hospital

    Beijing

  • Beijing Haidian women and children's Hospital

    Beijing

  • Dongguan women and children's hospital

    Dongguan, Guangdong

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510623

  • Shijiazhuang Obstetric and Gynecology Hospital

    Shijiazhuang, Hebei

  • Tangshan maternal and child hospital

    Tangshan, Hebei

  • Xiamen maternal and child hospital

    Xiamen, Fujian

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Epidural analgesia
Keywords
Epidural labor analgesia, Analgesic effect, Maternal fever during labor
Medical subject headings
Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural analgesiaDrug

    Also called No other intervention

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

Study groups in NCT04940091
Study groupRoleWhat they receive
Epidural labor analgesiaAll participants will receive epidural analgesia during labor.
Receives: Drug: Epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of maternal fever during labor

    Maternal fever is defined as temperature of ≥38℃ during any stage of labor.

    Measured: delivery ( the end of childbirth.)

Secondary outcomes (9)

  1. Occurrence of mild maternal fever during labor

    Mild maternal fever is defined as temperature of >37.5℃ during any stage of labor.

    Measured: delivery ( the end of childbirth.)

  2. Duration of labor

    Duration of the first, second, and third stage of labor.

    Measured: delivery ( the end of childbirth.)

  3. Neonatal Apgar score

    Apgar score is assessed at 1 and 5 minutes after birth.

    Measured: At 1 and 5 minutes after birth.

  4. Postpartum hospital stay

    Postpartum hospital stay

    Measured: Up to 42 days after childbirth.

  5. 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).

    Measured: At 1, 10 and 42 days after childbirth

  6. Postpartum breastfeeding

    The status of breastfeeding include breastfeeding, formula milk, or a mix of them.

    Measured: At 1, 10 and 42 days after childbirth

  7. 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.

    Measured: At 42 days after childbirth

  8. 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.

    Measured: At 10 and 42 days postpartum

  9. Postpartum complications

    Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention.

    Measured: Up to 42 days postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start10 Jun 2021
  3. Primary completion5 Feb 2022
  4. Study completion21 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,051 participants (actual)
Target duration
42 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04940091
Sponsor's protocol ID
2021-173
Status last verified
Mar 2025
First submitted
9 Jun 2021
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23972746

  • 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.

    PubMed 2566791

  • 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.

    PubMed 1751270

  • 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.

    PubMed 11641687

  • 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.

    PubMed 11873026

  • 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.

    PubMed 9316951

  • 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.

    PubMed 7566849

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

    PubMed 28079555

  • 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.

    PubMed 21992451

  • Perlman JM. Maternal fever and neonatal depression: preliminary observations. Clin Pediatr (Phila). 1999 May;38(5):287-91. doi: 10.1177/000992289903800506.

    PubMed 10349526

  • 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.

    PubMed 28103590

  • 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.

    PubMed 24118104

  • 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.

    PubMed 26536344

  • 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.

    PubMed 11061764

  • 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.

    PubMed 23618409

Questions about this trial

What is this clinical trial studying?

An observational study of Epidural Analgesia and Analgesic Effect, run by Peking University First Hospital at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of maternal fever during labor (time frame: delivery ( the end of childbirth.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940091, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in