Epidural Analgesia and Maternal Fever During Labor

September 14, 2021 updated by: Dong-Xin Wang, Peking University First Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Fuxing Hospital
        • Contact:
          • Xu Ding, MD
      • Beijing, China
        • Not yet recruiting
        • Beijing Haidian women and children's Hospital
        • Contact:
          • Bo Lei, MD
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Shuo Wang, MD
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • Xiamen maternal and child hospital
        • Contact:
          • Jun-Xiang Jia, MD
    • Guangdong
      • Dongguan, Guangdong, China
        • Not yet recruiting
        • Dongguan Women and Children's Hospital
        • Contact:
          • Xiang-Dong Wang, MD
      • Guangzhou, Guangdong, China, 510623
        • Not yet recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • Shijiazhuang Obstetric and Gynecology Hospital
        • Contact:
          • Jin Zhang, MD
      • Tangshan, Hebei, China
        • Not yet recruiting
        • Tangshan maternal and child hospital
        • Contact:
          • Jun-Li Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Epidural labor analgesia
All participants will receive epidural analgesia during labor.
Drug: Epidural analgesia
Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
Other Names:
  • No other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of maternal fever during labor
Time Frame: delivery ( the end of childbirth.)
Maternal fever is defined as temperature of ≥38℃ during any stage of labor.
delivery ( the end of childbirth.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of mild maternal fever during labor
Time Frame: delivery ( the end of childbirth.)
Mild maternal fever is defined as temperature of >37.5℃ during any stage of labor.
delivery ( the end of childbirth.)
Duration of labor
Time Frame: delivery ( the end of childbirth.)
Duration of the first, second, and third stage of labor.
delivery ( the end of childbirth.)
Neonatal Apgar score
Time Frame: At 1 and 5 minutes after birth.
Apgar score is assessed at 1 and 5 minutes after birth.
At 1 and 5 minutes after birth.
Postpartum hospital stay
Time Frame: Up to 42 days after childbirth.
Postpartum hospital stay
Up to 42 days after childbirth.
Postpartum pain intensity
Time Frame: At 1, 10 and 42 days after childbirth
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
Postpartum breastfeeding
Time Frame: At 1, 10 and 42 days after childbirth
The status of breastfeeding include breastfeeding, formula milk, or a mix of them.
At 1, 10 and 42 days after childbirth
Postpartum persistent pain
Time Frame: At 42 days after childbirth
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
Postpartum depression score
Time Frame: At 10 and 42 days postpartum
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
Postpartum complications
Time Frame: Up to 42 days postpartum
Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention.
Up to 42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Guangdong Women and Children Hospital
Tangshan Maternal and Child Health Hospital
Dongguan Maternal and Child Health Hospital
Beijing Haidian Maternal and Child Health Hospital
Beijing Fuxing Hospital
Fourth Hospital of Shijiazhuang City
Xiamen Maternity & Child Care Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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