Trial | NCT02625454  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    acetaminophen ...

  • Study Participants

    168
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.
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 Started
Dec 31
2016
Primary Completion
May 31
2019
Study Completion
Oct 31
2019
Anticipated
Last Update
Jul 17
2019

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

Intravenous Acetaminophen Experimental

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

Oral Acetaminophen Active Comparator

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

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
No Results Posted