Reduction of Intrapartum Fever With Intravenous Acetaminophen

ID: NCT02625454
Status: Recruiting
Phase: Phase 2
Start Date: December 01, 2016
First Submitted: December 01, 2015
Last Updated: February 14, 2018
Results: N/A
Sponsors & Collaborators: Richmond University Medical Center
Location: United States
Conditions: Fever, Oxidative Stress
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Study Description

Brief Summary

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.

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.
Condition or disease Intervention/treatment Phase

Fever

Oxidative Stress

Drug: Intravenous Acetaminophen
Other Names
OFIRMEV
Drug: Oral Acetaminophen
Other Names
Tylenol
Phase 2

Tracking Information

First Submitted DateDecember 01, 2015
Last Update Posted DateFebruary 14, 2018
Start DateDecember 01, 2016
Anticipated Completion DateJuly 01, 2018
Primary Completion DateJuly 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome 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]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleReduction of Intrapartum Fever With Intravenous Acetaminophen
Official TitleRandomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia
Brief Summary

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.

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.

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
168
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Fever
Oxidative Stress
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Intravenous Acetaminophen

1000 mg Acetaminophen q 6 hours, given intravenously

Other Names
OFIRMEV
Drug: Oral Acetaminophen

1000 mg Acetaminophen q 6 hours given orally

Other Names
Tylenol
Study Groups/Cohorts
Intravenous Acetaminophen
Subjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen

Oral Acetaminophen
Subjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen

Study Arms
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
Drug : Intravenous Acetaminophen
1000 mg Acetaminophen q 6 hours, given intravenously

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
Drug : Oral Acetaminophen
1000 mg Acetaminophen q 6 hours given orally

Arm Intervention/Treatment
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
Drug : Intravenous 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
Drug : Oral Acetaminophen

Recruitment Information

Recruitment Status:Recruiting
Enrollment168
Completion DateJuly 01, 2018
Eligibility Criteria: 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
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02625454
Other Study ID Numbers
2015-09-06 RUMC
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyNisha Lakhi, Richmond University Medical Center
Study Sponsor
Richmond University Medical Center
Collaborators
Not Available
Investigators
Principal Investigator
Nisha Lakhi, MD
Richmond University Medical Center