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FeverPhase 2RIFIVANCT02625454

Reduction of Intrapartum Fever With Intravenous Acetaminophen

A Phase 2 study testing Intravenous Acetaminophen and Oral Acetaminophen in people with Fever and Oxidative Stress, run by Richmond University Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fever, Oxidative Stress
What is being tested?
Intravenous Acetaminophen and Oral Acetaminophen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteUnited States
Study dates
Dec 2016to Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients at Richmond University Medical Center that entered active labor (spontaneous or induced) and developed a systemic fever of greater than 38 degrees Celsius.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Richmond University Medical Center

    Staten Island, New York, 10310

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Intravenous Acetaminophen, Oral Acetaminophen
Keywords
Acetaminophen, Labor, Intrapartum Fever, Maternal Fever, Fetal Tachycardia, Intravenous Acetaminophen
Medical subject headings
Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous AcetaminophenDrug

    Also called OFIRMEV

    1000 mg Acetaminophen q 6 hours, given intravenously

  • Oral AcetaminophenDrug

    Also called Tylenol

    1000 mg Acetaminophen q 6 hours given orally

Study groups in NCT02625454
Study groupRoleWhat they receive
Intravenous AcetaminophenExperimentalSubjects will receive 1000 mg of intravenous Acetaminophen q 6 hours, up to two doses and an oral placebo resembling oral acetaminophen
Receives: Drug: Intravenous Acetaminophen
Oral AcetaminophenActive comparatorSubjects will receive 1000 mg of oral Acetaminophen q 6 hours, up to two doses and an intravenous placebo resembling intravenous acetaminophen
Receives: Drug: Oral Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maternal Body Temperature

    Measured: 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 (18)

  1. Change in Fetal Heart Rate

    Measured: 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)

    Measured: Measured at point of delivery

  3. Number of Cesarean Deliveries for Persistent Fetal Tachycardia

    Measured: Measured at the point of delivery

  4. Number of Patients with Diagnosis of Clinical Chorioamnionitis

    Measured: Measured from admission to 7 days post-partum

  5. Number of Patients with Diagnosis of Histological Chorioamnionitis

    Measured: Measured from placenta histology collected at delivery

  6. Neonatal Apgar Score

    Measured: One and Five minutes of life

  7. Number of Infants Admitted to Neonatal Intensive Care Unit

    Measured: First 7 days of life

  8. Number of Infants with Culture Positive Neonatal Sepsis

    Measured: First 7 days of life

  9. Number of infants requiring additional respiratory intervention

    Measured: First 24 hours of life

  10. Number of Infants Developing Neonatal Seizures

    Measured: First 7 days of life

  11. Number of infants with fetal acidosis

    Measured: Point of Delivery

  12. Maternal Levels of Pro-Inflammatory Mediators

    C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

    Measured: Admission and 4 hours after delivery

  13. Levels of Pro-Inflammatory Mediator in Infant, collected from umbilical cord blood

    C-Reactive Protein (CRP), Tumor Necrosis Factor Alpha (TNF-α), Interleukin 6 (IL-6)

    Measured: Point of Delivery

  14. Maternal Levels of Oxidative Stress Markers

    Thioredoxin Reductase (TrxR), Gluathione (GSH)

    Measured: Admission and 4 hours after delivery

  15. Levels of Oxidative Stress Markers in Infant, collected from umbilical cord blood

    Thioredoxin Reductase (TrxR), Gluathione (GSH)

    Measured: point of delivery

  16. Levels of Acetaminophen in Cord Blood

    Measured: point of delivery

  17. Maternal Liver Function Test

    aspartate aminotransferase (AST), alanine aminotransferase (ALT)

    Measured: 12-24 hours after delivery

  18. Maternal White Blood Count (WBC)

    Measured: Admission and 12-24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study startDec 2016
  3. Primary completionMay 2019
  4. Study completionOct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625454
Sponsor's protocol ID
2015-09-06 RUMC
Acronym
RIFIVA
Status last verified
Jul 2019
First submitted
1 Dec 2015
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33451627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous Acetaminophen and Oral Acetaminophen in people with Fever and Oxidative Stress, run by Richmond University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625454, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.

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