Reduction of Intrapartum Fever With Intravenous Acetaminophen

Oxidative Stress Clinical Trial

— RIFIVA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02625454
• Other study ID #: 2015-09-06 RUMC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: October 2019

Study information

• Verified date: July 2019
• Source: Richmond University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: October 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Oxidative Stress

Intervention

Drug:
• Intravenous Acetaminophen
1000 mg Acetaminophen q 6 hours, given intravenously
• Oral Acetaminophen
1000 mg Acetaminophen q 6 hours given orally

Locations

Country	Name	City	State
United States	Richmond University Medical Center	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Richmond University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mode of Delivery (cesarean section vs vaginal delivery)		Measured at point of delivery
Secondary	Number of Cesarean Deliveries for Persistent Fetal Tachycardia		Measured at the point of delivery
Secondary	Number of Patients with Diagnosis of Clinical Chorioamnionitis		Measured from admission to 7 days post-partum
Secondary	Number of Patients with Diagnosis of Histological Chorioamnionitis		Measured from placenta histology collected at delivery
Secondary	Neonatal Apgar Score		One and Five minutes of life
Secondary	Number of Infants Admitted to Neonatal Intensive Care Unit		First 7 days of life
Secondary	Number of Infants with Culture Positive Neonatal Sepsis		First 7 days of life
Secondary	Number of infants requiring additional respiratory intervention		First 24 hours of life
Secondary	Number of Infants Developing Neonatal Seizures		First 7 days of life
Secondary	Number of infants with fetal acidosis		Point of Delivery
Secondary	Maternal Levels of Pro-Inflammatory Mediators	C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-a), Interleukin 6 (IL-6)	Admission and 4 hours after delivery
Secondary	Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood	C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-a), Interleukin 6 (IL-6)	Point of Delivery
Secondary	Maternal Levels of Oxidative Stress Markers	Thioredoxin Reductase (TrxR), Gluathione (GSH)	Admission and 4 hours after delivery
Secondary	Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood	Thioredoxin Reductase (TrxR), Gluathione (GSH)	point of delivery
Secondary	Levels of Acetaminophen in Cord Blood		point of delivery
Secondary	Maternal Liver Function Test	aspartate aminotransferase (AST), alanine aminotransferase (ALT)	12-24 hours after delivery
Secondary	Maternal White Blood Count (WBC)		Admission and 12-24 hours after delivery