Reduction of Intrapartum Fever With Intravenous Acetaminophen

Overview

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.

Full Title of Study: “Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 2019

Detailed Description

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.

Interventions

  • Drug: Intravenous Acetaminophen
    • 1000 mg Acetaminophen q 6 hours, given intravenously
  • Drug: Oral Acetaminophen
    • 1000 mg Acetaminophen q 6 hours given orally

Arms, Groups and Cohorts

  • Experimental: Intravenous Acetaminophen
    • Subjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen
  • Active Comparator: Oral Acetaminophen
    • Subjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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
    • Time Frame: Admission and 4 hours after delivery
    • C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
  • Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood
    • Time Frame: Point of Delivery
    • C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
  • Maternal Levels of Oxidative Stress Markers
    • Time Frame: Admission and 4 hours after delivery
    • Thioredoxin Reductase (TrxR), Gluathione (GSH)
  • Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood
    • Time Frame: point of delivery
    • Thioredoxin Reductase (TrxR), Gluathione (GSH)
  • Levels of Acetaminophen in Cord Blood
    • Time Frame: point of delivery
  • Maternal Liver Function Test
    • Time Frame: 12-24 hours after delivery
    • aspartate aminotransferase (AST), alanine aminotransferase (ALT)
  • Maternal White Blood Count (WBC)
    • Time Frame: Admission and 12-24 hours after delivery

Participating in This Clinical Trial

Inclusion Criteria

  • Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius.

Exclusion Criteria

Exclusion Criteria

Infants delivered before 36 week gestation, stillbirths, congenital fetal anomalies, scheduled cesarean deliveries, and acetaminophen allergy

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Richmond University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nisha Lakhi, MD, OBGYN Director of Research – Richmond University Medical Center
  • Overall Official(s)
    • Nisha Lakhi, MD, Principal Investigator, Richmond University Medical Center

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