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NCT Number: NCT04940091

Epidural Analgesia and Maternal Fever During Labor

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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°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.;
  • 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.

Treatment and study plan

Epidural analgesia

Drug

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

Other names: No other intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Duration of labor

    Time frame: delivery ( the end of childbirth.)

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

  3. Neonatal Apgar score

    Time frame: At 1 and 5 minutes after birth.

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

  4. Postpartum hospital stay

    Time frame: Up to 42 days after childbirth.

    Postpartum hospital stay

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Haidian Maternal and Child Health Hospital
  • Dongguan Maternal and Children Health Hospital
  • Fu Xing Hospital, Capital Medical University
  • Guangdong Women and Children Hospital
  • Tangshan Maternal and Child Health Hospital
  • The Fourth Hospital of Shijiazhuang
  • Xiamen Maternity & Child Care Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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