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Reduction of Intrapartum Fever With Intravenous Acetaminophen (RIFIVA)

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ClinicalTrials.gov Identifier: NCT02625454
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Nisha Lakhi, MD, 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.

Condition or disease Intervention/treatment Phase
Fever Oxidative Stress Drug: Intravenous Acetaminophen Drug: Oral Acetaminophen Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia
Study Start Date : December 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Intravenous Acetaminophen
Subjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen
Drug: Intravenous Acetaminophen
1000 mg Acetaminophen q 6 hours, given intravenously
Other Name: OFIRMEV

Active Comparator: Oral Acetaminophen
Subjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen
Drug: Oral Acetaminophen
1000 mg Acetaminophen q 6 hours given orally
Other Name: Tylenol




Primary Outcome Measures :
  1. Change in Maternal Body Temperature [ Time Frame: 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 :
  1. Change in Fetal Heart Rate [ Time Frame: 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 ]
  2. Mode of Delivery (cesarean section vs vaginal delivery) [ Time Frame: Measured at point of delivery ]
  3. Number of Cesarean Deliveries for Persistent Fetal Tachycardia [ Time Frame: Measured at the point of delivery ]
  4. Number of Patients with Diagnosis of Clinical Chorioamnionitis [ Time Frame: Measured from admission to 7 days post-partum ]
  5. Number of Patients with Diagnosis of Histological Chorioamnionitis [ Time Frame: Measured from placenta histology collected at delivery ]
  6. Neonatal Apgar Score [ Time Frame: One and Five minutes of life ]
  7. Number of Infants Admitted to Neonatal Intensive Care Unit [ Time Frame: First 7 days of life ]
  8. Number of Infants with Culture Positive Neonatal Sepsis [ Time Frame: First 7 days of life ]
  9. Number of infants requiring additional respiratory intervention [ Time Frame: First 24 hours of life ]
  10. Number of Infants Developing Neonatal Seizures [ Time Frame: First 7 days of life ]
  11. Number of infants with fetal acidosis [ Time Frame: Point of Delivery ]
  12. Maternal Levels of Pro-Inflammatory Mediators [ Time Frame: Admission and 4 hours after delivery ]
    C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

  13. Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood [ Time Frame: Point of Delivery ]
    C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

  14. Maternal Levels of Oxidative Stress Markers [ Time Frame: Admission and 4 hours after delivery ]
    Thioredoxin Reductase (TrxR), Gluathione (GSH)

  15. Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood [ Time Frame: point of delivery ]
    Thioredoxin Reductase (TrxR), Gluathione (GSH)

  16. Levels of Acetaminophen in Cord Blood [ Time Frame: point of delivery ]
  17. Maternal Liver Function Test [ Time Frame: 12-24 hours after delivery ]
    aspartate aminotransferase (AST), alanine aminotransferase (ALT)

  18. Maternal White Blood Count (WBC) [ Time Frame: Admission and 12-24 hours after delivery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625454


Contacts
Contact: Nisha Lakhi, MD 7188182109 nlakhi@yahoo.com
Contact: Michael Moretti, MD 7188182109 Mmoretti@rumcsi.org

Locations
United States, New York
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Nisha A Lakhi, MD    718-818-2109    NLAKHI@RUMCSI.ORG   
Contact: Michale M Moretti, MD    718-818-4213    MMORETTI@RUMCSI.ORG   
Sponsors and Collaborators
Richmond University Medical Center
Investigators
Principal Investigator: Nisha Lakhi, MD Richmond University Medical Center

Responsible Party: Nisha Lakhi, MD, OBGYN Director of Research, Richmond University Medical Center
ClinicalTrials.gov Identifier: NCT02625454     History of Changes
Other Study ID Numbers: 2015-09-06 RUMC
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Keywords provided by Nisha Lakhi, MD, Richmond University Medical Center:
Acetaminophen
Labor
Intrapartum Fever
Maternal Fever
Fetal Tachycardia
Intravenous Acetaminophen

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics