- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625454
Reduction of Intrapartum Fever With Intravenous Acetaminophen (RIFIVA)
Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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Staten Island, New York, United States, 10310
- Richmond University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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:
|
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
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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
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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
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Measured at point of delivery
|
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Number of Cesarean Deliveries for Persistent Fetal Tachycardia
Time Frame: Measured at the point of delivery
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Measured at the point of delivery
|
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Number of Patients with Diagnosis of Clinical Chorioamnionitis
Time Frame: Measured from admission to 7 days post-partum
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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
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Measured from placenta histology collected at delivery
|
|
Neonatal Apgar Score
Time Frame: One and Five minutes of life
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One and Five minutes of life
|
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Number of Infants Admitted to Neonatal Intensive Care Unit
Time Frame: First 7 days of life
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First 7 days of life
|
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Number of Infants with Culture Positive Neonatal Sepsis
Time Frame: First 7 days of life
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First 7 days of life
|
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Number of infants requiring additional respiratory intervention
Time Frame: First 24 hours of life
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First 24 hours of life
|
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Number of Infants Developing Neonatal Seizures
Time Frame: First 7 days of life
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First 7 days of life
|
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Number of infants with fetal acidosis
Time Frame: Point of Delivery
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Point of Delivery
|
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Maternal Levels of Pro-Inflammatory Mediators
Time Frame: Admission and 4 hours after delivery
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C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
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Admission and 4 hours after delivery
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Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood
Time Frame: Point of Delivery
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C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
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Point of Delivery
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Maternal Levels of Oxidative Stress Markers
Time Frame: Admission and 4 hours after delivery
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Thioredoxin Reductase (TrxR), Gluathione (GSH)
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Admission and 4 hours after delivery
|
Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood
Time Frame: point of delivery
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Thioredoxin Reductase (TrxR), Gluathione (GSH)
|
point of delivery
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Levels of Acetaminophen in Cord Blood
Time Frame: point of delivery
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point of delivery
|
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Maternal Liver Function Test
Time Frame: 12-24 hours after delivery
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aspartate aminotransferase (AST), alanine aminotransferase (ALT)
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12-24 hours after delivery
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Maternal White Blood Count (WBC)
Time Frame: Admission and 12-24 hours after delivery
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Admission and 12-24 hours after delivery
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Collaborators and Investigators
Investigators
- Principal Investigator: Nisha Lakhi, MD, Richmond University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-09-06 RUMC
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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