Epidural Analgesia and Maternal Fever During Labor

NCT04940091 | Completed

• 1 other identifier: 2021-173
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Epidural Analgesia; Analgesic Effect; Fever

Keywords

Epidural labor analgesia; Analgesic effect; Maternal fever during labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Occurrence of mild maternal fever during labor

  delivery ( the end of childbirth.)

• Duration of labor

  delivery ( the end of childbirth.)

• Neonatal Apgar score

  At 1 and 5 minutes after birth.

• Postpartum hospital stay

  Up to 42 days after childbirth.

• Postpartum pain intensity

  At 1, 10 and 42 days after childbirth

Study Arms (1)

Epidural labor analgesia

All participants will receive epidural analgesia during labor.

Drug: Epidural analgesia

Interventions

Epidural analgesia DRUG

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

Also known as: No other intervention

Epidural labor analgesia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Guangdong Women and Children Hospital: collaborator
• Tangshan Maternal and Child Health Hospital: collaborator
• Dongguan Maternal and Child Health Hospital: collaborator
• Beijing Haidian Maternal and Child Health Hospital: collaborator
• Beijing Fuxing Hospital: collaborator
• The Fourth Hospital of Shijiazhuang: collaborator
• Xiamen Maternity & Child Care Hospital: collaborator

Study Sites (8)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Xiamen maternal and child hospital

Xiamen, Fujian, China

Location

Dongguan women and children's hospital

Dongguan, Guangdong, China

Location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

Shijiazhuang Obstetric and Gynecology Hospital

Shijiazhuang, Hebei, China

Location

Tangshan maternal and child hospital

Tangshan, Hebei, China

Location

Beijing Fuxing Hospital

Beijing, China

Location

Beijing Haidian women and children's Hospital

Beijing, China

Location

Related Publications (26)

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MeSH Terms

Conditions

Fever

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 42 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 25, 2021
• Study Start: June 10, 2021
• Primary Completion: February 5, 2022
• Study Completion: March 21, 2022
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)