Reduction of Intrapartum Fever With Intravenous Acetaminophen

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

Sponsors

Lead Sponsor: Richmond University Medical Center

Source Richmond University Medical Center
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.

Overall Status Active, not recruiting
Start Date December 2016
Completion Date October 2019
Primary Completion Date May 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Maternal Body Temperature 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
Measure Time Frame
Change in Fetal Heart Rate 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) Measured at point of delivery
Number of Cesarean Deliveries for Persistent Fetal Tachycardia Measured at the point of delivery
Number of Patients with Diagnosis of Clinical Chorioamnionitis Measured from admission to 7 days post-partum
Number of Patients with Diagnosis of Histological Chorioamnionitis Measured from placenta histology collected at delivery
Neonatal Apgar Score One and Five minutes of life
Number of Infants Admitted to Neonatal Intensive Care Unit First 7 days of life
Number of Infants with Culture Positive Neonatal Sepsis First 7 days of life
Number of infants requiring additional respiratory intervention First 24 hours of life
Number of Infants Developing Neonatal Seizures First 7 days of life
Number of infants with fetal acidosis Point of Delivery
Maternal Levels of Pro-Inflammatory Mediators Admission and 4 hours after delivery
Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood Point of Delivery
Maternal Levels of Oxidative Stress Markers Admission and 4 hours after delivery
Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood point of delivery
Levels of Acetaminophen in Cord Blood point of delivery
Maternal Liver Function Test 12-24 hours after delivery
Maternal White Blood Count (WBC) Admission and 12-24 hours after delivery
Enrollment 168
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intravenous Acetaminophen

Description: 1000 mg Acetaminophen q 6 hours, given intravenously

Arm Group Label: Intravenous Acetaminophen

Other Name: OFIRMEV

Intervention Type: Drug

Intervention Name: Oral Acetaminophen

Description: 1000 mg Acetaminophen q 6 hours given orally

Arm Group Label: Oral Acetaminophen

Other Name: Tylenol

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nisha Lakhi, MD Principal Investigator Richmond University Medical Center
Location
Facility: Richmond University Medical Center
Location Countries

United States

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Richmond University Medical Center

Investigator Full Name: Nisha Lakhi, MD

Investigator Title: OBGYN Director of Research

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intravenous Acetaminophen

Type: Experimental

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

Label: Oral Acetaminophen

Type: Active Comparator

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

Acronym RIFIVA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov