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Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, September 2008

Sponsored by: 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

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

MedlinePlus related topics:   Fever   

ChemIDplus related topics:   Acetaminophen   

U.S. FDA Resources

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

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

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:

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

Secondary outcome measures are:

  1. Temperature difference before and after treatment
  2. Rate of cesarean delivery
  3. Rate of determination of NRFS
  4. Rate of subsequent development of maternal fever
  5. Rate of diagnosis of clinical chorioamnionitis
  6. 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


Responsible Party:   Weill Medical College of Cornell University ( Tina M. Calia, MA )
Study ID Numbers:   0605008549, 4730406
First Received:   September 14, 2006
Last Updated:   September 8, 2008
ClinicalTrials.gov Identifier:   NCT00377832
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  

Study placed in the following topic categories:
Fever
Fetal Distress
Heart Diseases
Tachycardia
Acetaminophen
Arrhythmias, Cardiac

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 10, 2008




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