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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00377832 |
The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will significantly lower maternal body temperature and significantly lower baseline fetal heart rate. The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.
Condition | Intervention |
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Fever Heart Rate, Fetal |
Drug: Acetaminophen 975 mg |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial |
Estimated Enrollment: | 54 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention | |
2: Active Comparator
Acetaminophen 975 mg once
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Drug: Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
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This trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia.
Term singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. Patient will be excluded for:
Primary outcome measures are:
Secondary outcome measures are:
Power calculation Internal data collection at our institution of 53 patients showed a mean decrease in temperature of patients in labor with fever receiving acetaminophen is 0.3 degrees C measured an average (mean) of 90 minutes after administration of acetaminophen. Mean oral temperature before acetaminophen was 38.32, SD 0.33. Mean oral temperature after acetaminophen was 38.03, SD 0.85.
Sample size calculation shows that 27 patients are needed in each group to show significant difference using alpha 5% and beta 50%.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel W Skupski, MD | 718-670-1495 | dwskupsk@med.cornell.edu |
United States, New York | |
New York Hospital Medical Center of Queens | Recruiting |
Flushing, New York, United States, 11355 | |
Principal Investigator: Daniel W Skupski, MD |
Principal Investigator: | Daniel W Skupski, MD | Weill Medical College of Cornell University, New York Hospital Medical Center of Queens |
Responsible Party: | Weill Medical College of Cornell University ( Tina M. Calia, MA ) |
Study ID Numbers: | 0605008549, 4730406 |
Study First Received: | September 14, 2006 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00377832 |
Health Authority: | United States: Institutional Review Board |
Fetal tachycardia Fever in labor Acetaminophen Non reassuring fetal status |
Fever Fetal Distress Heart Diseases |
Tachycardia Acetaminophen Arrhythmias, Cardiac |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |