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,
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* 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 |
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