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| Name | Class |
|---|---|
| Guangdong Women and Children Hospital | OTHER |
| Tangshan Maternal and Child Health Hospital | OTHER |
| Dongguan Maternal and Children Health Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural labor analgesia | All participants will receive epidural analgesia during labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Drug | Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of maternal fever during labor | Maternal fever is defined as temperature of ≥38℃ during any stage of labor. | delivery ( the end of childbirth.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| Duration of labor | Duration of the first, second, and third stage of labor. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women
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Adult (≥18 years old) nulliparae with single term cephalic pregnancy preparing to give vaginal delivery under epidural analgesia.
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Xiamen maternal and child hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23972746 | Background | 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. | |
| 2566791 | Background | 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. |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Beijing Haidian Maternal and Child Health Hospital |
| OTHER |
| Beijing Fuxing Hospital | UNKNOWN |
| The Fourth Hospital of Shijiazhuang | OTHER |
| Xiamen Maternity & Child Care Hospital | OTHER |
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| delivery ( the end of childbirth.) |
| Neonatal Apgar score | Apgar score is assessed at 1 and 5 minutes after birth. | At 1 and 5 minutes after birth. |
| Postpartum hospital stay | Postpartum hospital stay | Up to 42 days after childbirth. |
| 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 |
| Postpartum breastfeeding | The status of breastfeeding include breastfeeding, formula milk, or a mix of them. | At 1, 10 and 42 days after childbirth |
| 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 |
| 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 |
| Postpartum complications | Include maternal and neonatal complications, indicate new onset medical events that are harmful and required therapeutic intervention. | Up to 42 days postpartum |
| Xiamen |
| Fujian |
| China |
| Dongguan women and children's hospital | Dongguan | Guangdong | China |
| Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong | 510623 | China |
| Shijiazhuang Obstetric and Gynecology Hospital | Shijiazhuang | Hebei | China |
| Tangshan maternal and child hospital | Tangshan | Hebei | China |
| Beijing Fuxing Hospital | Beijing | China |
| Beijing Haidian women and children's Hospital | Beijing | China |
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| 11641687 | Background | 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. |
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