Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia
试验速览
- 阶段
- 2 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in Maternal Body Temperature
研究概览
简要总结
The investigators plan to administer acetaminophen (Tylenol) for the treatment of fever in laboring patients by either an oral or intravenous (IV) route. The investigators want to see if the maternal fever will decrease faster with the IV or the oral dose. The investigators also want to look at other outcomes such as the cesarean section rate, the rate of neonatal intensive care unit admissions in both groups.
详细描述
This is a randomized, controlled, study of intravenous (IV) acetaminophen (OFIRMEV) versus orally administrated acetaminophen for the reduction of intrapartum maternal fever and fetal tachycardia. Compared to oral acetaminophen, intravenous acetaminophen has increased bioavailability and more rapid onset of action. IV acetaminophen has been used successfully in the management of fever in post-operative patients. Additionally, intravenous acetaminophen has also been used in the intrapartum setting for management of pain.However, the use of intravenous acetaminophen for the treatment of maternal temperature and subsequent fetal tachycardia, has not yet been evaluated.
The study will have two arms that will be randomized in a 1:1 ratio. A double dummy, double blind, comparator controlled study design will be utilized. After inclusion criteria have been satisfied, subjects in the control arm will receive an oral dose 1000 mg acetaminophen and an intravenous placebo resembling Ofirmev. The subjects in the experimental arm will receive 1000 mg of IV Ofirmev and an oral placebo resembling acetaminophen. Both groups will receive standard obstetrical care, continuous fetal monitoring, and antibiotics if there is suspected chorioamnionitis. The blinding technique will eliminate provider bias.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius.
排除标准
- •Exclusion Criteria: Infants delivered before 36 week gestation, stillbirths, congenital fetal anomalies, scheduled cesarean deliveries, and acetaminophen allergy
研究组 & 干预措施
Intravenous Acetaminophen
Subjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen
干预措施: Intravenous Acetaminophen (Drug)
Oral Acetaminophen
Subjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen
干预措施: Oral Acetaminophen (Drug)
结局指标
主要结局
Change in Maternal Body Temperature
时间窗: 01, 15, 30, 60 and 90, 120, 180, 240, 300, 360 minutes following Time 01 (Time 01 = time when first dose of acetaminophen was administered
次要结局
- Change in Fetal Heart Rate(01, 15, 30, 60 and 90, 120, 180, 240, 300, 360 minutes following Time 01 (Time 01 = time when first dose of acetaminophen was administered)
- Mode of Delivery (cesarean section vs vaginal delivery)(Measured at point of delivery)
- Number of Cesarean Deliveries for Persistent Fetal Tachycardia(Measured at the point of delivery)
- Number of Patients with Diagnosis of Clinical Chorioamnionitis(Measured from admission to 7 days post-partum)
- Number of Patients with Diagnosis of Histological Chorioamnionitis(Measured from placenta histology collected at delivery)
- Neonatal Apgar Score(One and Five minutes of life)
- Number of Infants Admitted to Neonatal Intensive Care Unit(First 7 days of life)
- Number of Infants with Culture Positive Neonatal Sepsis(First 7 days of life)
- Number of infants requiring additional respiratory intervention(First 24 hours of life)
- Number of Infants Developing Neonatal Seizures(First 7 days of life)
- Number of infants with fetal acidosis(Point of Delivery)
- Maternal Levels of Pro-Inflammatory Mediators(Admission and 4 hours after delivery)
- Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood(point of delivery)
- Levels of Acetaminophen in Cord Blood(point of delivery)
- Maternal Levels of Oxidative Stress Markers(Admission and 4 hours after delivery)
- Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood(Point of Delivery)
- Maternal Liver Function Test(12-24 hours after delivery)
- Maternal White Blood Count (WBC)(Admission and 12-24 hours after delivery)
研究者
Nisha Lakhi, MD
OBGYN Director of Research
Richmond University Medical Center