Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Baseline Fetal Heart Rate (FHR) After Treatment
研究概览
简要总结
The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will significantly lower maternal body temperature and significantly lower baseline fetal heart rate (FHR). The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.
详细描述
This trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia.
Term singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. Patient will be excluded for:
- Exclusion criteria (prior to randomization):
- Acetaminophen allergy
- Clinical chorioamnionitis
- Maternal fever
- Non-reassuring fetal status (NRFS), which is the designation for fetal heart rate abnormalities requiring cesarean delivery
- Previous cesarean delivery
- Multifetal gestation
- Breech presentation
- Known fetal anomaly
- Known contraindication to vaginal delivery
Primary outcome measures are:
- Maternal body temperature (oral) 90 minutes after treatment
- Baseline FHR
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term pregnancy
- •Singleton pregnancy
- •Pregnancy with cephalic presentation
- •Pregnancy in active phase labor
- •Fetal tachycardia
排除标准
- •Acetaminophen allergy
- •Clinical chorioamnionitis
- •Maternal fever
- •Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
- •Previous cesarean delivery
- •Multifetal gestation
- •Breech presentation
- •Known fetal anomaly
- •Known contraindication to vaginal delivery
研究组 & 干预措施
2
Acetaminophen 975 mg once
干预措施: Acetaminophen 975 mg (Drug)
结局指标
主要结局
Baseline Fetal Heart Rate (FHR) After Treatment
时间窗: 90 minutes
Maternal Body Temperature 90 Minutes After Randomization
时间窗: 90 minutes
Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.
次要结局
- Temperature Difference Before and After Treatment(90 minutes)
- Rate of Cesarean Delivery(Labor--up to 24 hours)
- Rate of Determination of Non-reassuring Fetal Status(Labor--up to 24 hours)
- Rate of Subsequent Development of Maternal Fever(Labor--up to 24 hours)
- Rate of Diagnosis of Clinical Chorioamnionitis(Labor--up to 24 hours)
- Rate of Neonatal Sepsis(7 days)