Clinical trial NCT02625454: Reduction of Intrapartum Fever With Intravenous Acetaminophen
Official title: Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fever
Oxidative Stress
Keywords: Acetaminophen
Labor
Intrapartum Fever
Maternal Fever
Fetal Tachycardia
Intravenous Acetaminophen
Lead sponsor: Richmond University Medical Center
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Maternal Body Temperature
timeFrame: 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 outcomes:
measure: Change in Fetal Heart Rate
timeFrame: 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
measure: Mode of Delivery (cesarean section vs vaginal delivery)
timeFrame: Measured at point of delivery
measure: Number of Cesarean Deliveries for Persistent Fetal Tachycardia
timeFrame: Measured at the point of delivery
measure: Number of Patients with Diagnosis of Clinical Chorioamnionitis
timeFrame: Measured from admission to 7 days post-partum
measure: Number of Patients with Diagnosis of Histological Chorioamnionitis
timeFrame: Measured from placenta histology collected at delivery
measure: Neonatal Apgar Score
timeFrame: One and Five minutes of life
measure: Number of Infants Admitted to Neonatal Intensive Care Unit
timeFrame: First 7 days of life
measure: Number of Infants with Culture Positive Neonatal Sepsis
timeFrame: First 7 days of life
measure: Number of infants requiring additional respiratory intervention
timeFrame: First 24 hours of life
measure: Number of Infants Developing Neonatal Seizures
timeFrame: First 7 days of life
measure: Number of infants with fetal acidosis
timeFrame: Point of Delivery
measure: Maternal Levels of Pro-Inflammatory Mediators
timeFrame: Admission and 4 hours after delivery
measure: Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood
timeFrame: Point of Delivery
measure: Maternal Levels of Oxidative Stress Markers
timeFrame: Admission and 4 hours after delivery
measure: Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood
timeFrame: point of delivery
measure: Levels of Acetaminophen in Cord Blood
timeFrame: point of delivery
measure: Maternal Liver Function Test
timeFrame: 12-24 hours after delivery
measure: Maternal White Blood Count (WBC)
timeFrame: Admission and 12-24 hours after delivery
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
Study officials:
affiliation: Richmond University Medical Center
name: Nisha Lakhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehraban S, Nematian S, Mehraban SS, Petrucci S, Tricorico G, Parnas Z, Shats L, Kanninen T, Moretti M, Cabbad M, Lakhi N. Randomized control trial of intravenous acetaminophen for reduction of intrapartum maternal fever. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100287. doi: 10.1016/j.ajogmf.2020.100287. Epub 2020 Dec 9.