Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial - Full Text View

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00377832

Purpose

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
Fever Heart Rate, Fetal	Drug: Acetaminophen 975 mg

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Cesarean Section Fever

Drug Information available for: Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Maternal body temperature 90 minutes after treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Baseline FHR after treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Temperature difference before and after treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Rate of cesarean delivery [ Time Frame: Labor ] [ Designated as safety issue: No ]
Rate of determination of NRFS [ Time Frame: Labor ] [ Designated as safety issue: No ]
Rate of subsequent development of maternal fever [ Time Frame: Labor ] [ Designated as safety issue: No ]
Rate of diagnosis of clinical chorioamnionitis [ Time Frame: Labor ] [ Designated as safety issue: No ]
Rate of neonatal sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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
No Intervention: 1
Active Comparator: 2 Acetaminophen 975 mg once	Drug: Acetaminophen 975 mg Acetaminophen 975 mg by mouth once only Other Name: Tylenol

Detailed Description:

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:

Exclusion criteria (prior to randomization):
Acetaminophen allergy
Clinical chorioamnionitis
Maternal fever
Non-reassuring fetal status (NRFS)
Previous cesarean delivery
Multifetal gestation
Breech presentation
Known fetal anomaly
Known contraindication to vaginal delivery

Primary outcome measures are:

Maternal body temperature (oral) 90 minutes after treatment
Baseline FHR

Secondary outcome measures are:

Temperature difference before and after treatment
Rate of cesarean delivery
Rate of determination of NRFS
Rate of subsequent development of maternal fever
Rate of diagnosis of clinical chorioamnionitis
Rate of neonatal sepsis

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%.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Term pregnancy
Singleton pregnancy
Pregnancy with cephalic presentation
Pregnancy in active phase labor
Fetal tachycardia

Exclusion Criteria:

Acetaminophen allergy
Clinical chorioamnionitis
Maternal fever
Non-reassuring fetal status requiring cesarean delivery
Previous cesarean delivery
Multifetal gestation
Breech presentation
Known fetal anomaly
Known contraindication to vaginal delivery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377832

Contacts

Contact: Daniel W Skupski, MD

718-670-1495

dwskupsk@med.cornell.edu

Locations

United States, New York
New York Hospital Medical Center of Queens	Recruiting
Flushing, New York, United States, 11355
Principal Investigator: Daniel W Skupski, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Daniel W Skupski, MD

Weill Medical College of Cornell University, New York Hospital Medical Center of Queens

More Information

No publications provided

Responsible Party:	Tina M. Calia, MA, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00377832 History of Changes
Other Study ID Numbers:	0605008549, 4730406
Study First Received:	September 14, 2006
Last Updated:	September 8, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Fetal tachycardia
Fever in labor
Acetaminophen
Non reassuring fetal status

Additional relevant MeSH terms:

Fever
Tachycardia
Body Temperature Changes
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acetaminophen

Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012