Reduction of Intrapartum Fever With Intravenous Acetaminophen

Phase 2

• Conditions: Fever; Oxidative Stress
• Interventions: Drug: Oral Acetaminophen; Drug: Intravenous Acetaminophen

• Registration Number: NCT02625454
• Lead Sponsor: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Study Start: 2016-12
• Primary Completion: 2019-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 168

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.

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Exclusion Criteria

• Exclusion Criteria: Infants delivered before 36 week gestation, stillbirths, congenital fetal anomalies, scheduled cesarean deliveries, and acetaminophen allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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	C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood	point of delivery	Thioredoxin Reductase (TrxR), Gluathione (GSH)
Levels of Acetaminophen in Cord Blood	point of delivery
Maternal Levels of Oxidative Stress Markers	Admission and 4 hours after delivery	Thioredoxin Reductase (TrxR), Gluathione (GSH)
Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood	Point of Delivery	C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)
Maternal Liver Function Test	12-24 hours after delivery	aspartate aminotransferase (AST), alanine aminotransferase (ALT)
Maternal White Blood Count (WBC)	Admission and 12-24 hours after delivery

Trial Locations

Locations (1)

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States