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临床试验/NCT06950840
NCT06950840尚未招募4 期

Intravenous Dipyrone Compared With Intravenous Acetaminophen for Maternal Fever During Labor: A Randomised Controlled Trial

Wolfson Medical Center1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Time to defervesce

研究概览

简要总结

Chorioamnionitis, or intraamniotic infection, is a common condition affecting 2-5% of all term births. This condition poses well-recognized maternal and neonatal risks, and entails a series of clinical management decisions concerning both the mother and neonate. Therefore, timely detection and treatment of chorioamnionitis is of paramount importance. The occurrence of chorioamnionitis is associated with a higher risk of labor abnormalities, which increase the risk of cesarean delivery (CD) 3 to 4 fold.

As recommended by current guidelines, treatment of suspected intraamniotic infection should include broad-spectrum antibiotics. In addition, the use of antipyretics is advocated. This is particularly important during the intrapartum period since fetal acidosis in the setting of fever has been associated with a marked increase in the incidence of neonatal encephalopathy. Maternal fever even in the absence of documented fetal acidosis is associated with adverse neonatal outcomes, particularly neonatal encephalopathy, though it is unclear to what extent the etiology of the fever rather than the fever itself is causative . Furthermore, treating intrapartum fever with antipyretics may also be helpful in reducing fetal tachycardia thereby avoiding the tendency to perform cesarean for a non-reassuring fetal status. Nevertheless, it remains understudied which is the most appropriate antipyretic agent in this regard, where both dipyrone and acetaminophen are safe alternatives . Antipyretic agent with a faster onset of action may be preferable in this setting.

详细描述

Chorioamnionitis, or intraamniotic infection, affects 2-5% of term deliveries and is associated with significant maternal and neonatal risks, including a 3- to 4-fold increase in cesarean delivery. Management includes prompt antibiotic treatment and antipyretic use, particularly during labor, where maternal fever may contribute to fetal acidosis and increased risk of neonatal encephalopathy. Even in the absence of acidosis, maternal fever alone is linked to adverse neonatal outcomes. Antipyretics may also help resolve fetal tachycardia, potentially avoiding unnecessary cesarean sections. While both dipyrone and acetaminophen are considered safe, it remains unclear which has superior efficacy in the intrapartum setting, and an agent with faster onset may offer clinical advantages.

Stages of study: Following the diagnosis of suspected intrapartum intraamniotic infection, eligible women will be offered to participate. All women will be treated with the same broad-spectrum antibiotic regimen. As stated above, those who gave their informed consent will be randomly assigned to either dipyrone or acetaminophen.

After administering antipyretic treatment, oral temperature will be monitored every 5 minutes for up to 40 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing a trial of vaginal delivery, with suspected intra-amniotic infection defined as isolated maternal fever of 39°C or greater, or an sustained oral temperature of 38-38.9°C for at least 30 minutes or with one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia.

排除标准

  • Known history of adverse events for dipyrone or acetaminophen
  • Age <18 years
  • Gestational age <24 weeks
  • Intrauterine fetal death
  • Fever onset prior to delivery
  • Known liver disease
  • Known leukopenia
  • In addition, those who will develop allergic event or any adverse event possible related to any of the antipyretics used will be excluded from the

研究组 & 干预措施

Dipyrone

Experimental

Dipyrone IV 1 g once

干预措施: dipyrone (Drug)

Acetaminophen

Experimental

Acetaminophen 1 g IV once

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Time to defervesce

时间窗: 120 min

Time (minutes) from drug administration to temperature \< 38 °C

次要结局

  • Time to resolution of fetal tachycardia(120 min)
  • Mode of delivery(From enrollment to delivery)
  • Apgar scores(At 1 and 5 minutes after birth)
  • Neonatal arterial pH level(Immediately after birth)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

ilia kleiner

Specialist Obstetrician & Gynecologist; Director of Labor-and-Delivery Rooms and the Maternity Department

Wolfson Medical Center

研究点 (1)

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