Reduction of Intrapartum Fever With Intravenous Acetaminophen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fever Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intravenous Acetaminophen

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

Group Type EXPERIMENTAL

Intravenous Acetaminophen

Intervention Type DRUG

1000 mg Acetaminophen q 6 hours, given intravenously

Oral Acetaminophen

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

Group Type ACTIVE_COMPARATOR

Oral Acetaminophen

Intervention Type DRUG

1000 mg Acetaminophen q 6 hours given orally

Interventions

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Intravenous Acetaminophen

1000 mg Acetaminophen q 6 hours, given intravenously

Intervention Type DRUG

Oral Acetaminophen

1000 mg Acetaminophen q 6 hours given orally

Intervention Type DRUG

Other Intervention Names

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OFIRMEV Tylenol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No