Reduction of Intrapartum Fever With Intravenous Acetaminophen (RIFIVA)

July 16, 2019 updated by: Nisha Lakhi, MD, Richmond University Medical Center

Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
1000 mg Acetaminophen q 6 hours, given intravenously
Other Names:
  • OFIRMEV
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
1000 mg Acetaminophen q 6 hours given orally
Other Names:
  • Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Measured at point of delivery
Number of Cesarean Deliveries for Persistent Fetal Tachycardia
Time Frame: Measured at the point of delivery
Measured at the point of delivery
Number of Patients with Diagnosis of Clinical Chorioamnionitis
Time Frame: Measured from admission to 7 days post-partum
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
Measured from placenta histology collected at delivery
Neonatal Apgar Score
Time Frame: One and Five minutes of life
One and Five minutes of life
Number of Infants Admitted to Neonatal Intensive Care Unit
Time Frame: First 7 days of life
First 7 days of life
Number of Infants with Culture Positive Neonatal Sepsis
Time Frame: First 7 days of life
First 7 days of life
Number of infants requiring additional respiratory intervention
Time Frame: First 24 hours of life
First 24 hours of life
Number of Infants Developing Neonatal Seizures
Time Frame: First 7 days of life
First 7 days of life
Number of infants with fetal acidosis
Time Frame: Point of Delivery
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)
Admission and 4 hours after delivery
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)
Point of Delivery
Maternal Levels of Oxidative Stress Markers
Time Frame: Admission and 4 hours after delivery
Thioredoxin Reductase (TrxR), Gluathione (GSH)
Admission and 4 hours after delivery
Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood
Time Frame: point of delivery
Thioredoxin Reductase (TrxR), Gluathione (GSH)
point of delivery
Levels of Acetaminophen in Cord Blood
Time Frame: point of delivery
point of delivery
Maternal Liver Function Test
Time Frame: 12-24 hours after delivery
aspartate aminotransferase (AST), alanine aminotransferase (ALT)
12-24 hours after delivery
Maternal White Blood Count (WBC)
Time Frame: Admission and 12-24 hours after delivery
Admission and 12-24 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nisha Lakhi, MD, Richmond University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

May 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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