Reduction of Intrapartum Fever With Intravenous Acetaminophen
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/31/2018 |
| Start Date: | December 2016 |
| End Date: | October 2018 |
| Contact: | Nisha Lakhi, MD |
| Email: | nlakhi@yahoo.com |
| Phone: | 7188182109 |
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.
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.
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.
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.
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
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