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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
168
1000 mg Acetaminophen q 6 hours, given intravenously
1000 mg Acetaminophen q 6 hours given orally
Richmond University Medical Center
Staten Island, New York, United States
Change in Maternal Body Temperature
Time frame: 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
Change in Fetal Heart Rate
Time frame: 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)
Time frame: Measured at point of delivery
Number of Cesarean Deliveries for Persistent Fetal Tachycardia
Time frame: Measured at the point of delivery
Number of Patients with Diagnosis of Clinical Chorioamnionitis
Time frame: Measured from admission to 7 days post-partum
Number of Patients with Diagnosis of Histological Chorioamnionitis
Time frame: Measured from placenta histology collected at delivery
Neonatal Apgar Score
Time frame: One and Five minutes of life
Number of Infants Admitted to Neonatal Intensive Care Unit
Time frame: First 7 days of life
Number of Infants with Culture Positive Neonatal Sepsis
Time frame: First 7 days of life
Number of infants requiring additional respiratory intervention
Time frame: First 24 hours of life
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Number of Infants Developing Neonatal Seizures
Time frame: First 7 days of life
Number of infants with fetal acidosis
Time frame: Point of Delivery
Maternal Levels of Pro-Inflammatory Mediators
C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
Time frame: Admission and 4 hours after delivery
Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood
C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
Time frame: Point of Delivery
Maternal Levels of Oxidative Stress Markers
Thioredoxin Reductase (TrxR), Gluathione (GSH)
Time frame: Admission and 4 hours after delivery
Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood
Thioredoxin Reductase (TrxR), Gluathione (GSH)
Time frame: point of delivery
Levels of Acetaminophen in Cord Blood
Time frame: point of delivery
Maternal Liver Function Test
aspartate aminotransferase (AST), alanine aminotransferase (ALT)
Time frame: 12-24 hours after delivery
Maternal White Blood Count (WBC)
Time frame: Admission and 12-24 hours after delivery