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Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

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ClinicalTrials.gov Identifier: NCT00377832
Recruitment Status : Terminated (Poor recruitment and lack of funding)
First Posted : September 18, 2006
Results First Posted : September 16, 2013
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
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 (FHR). The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.

Condition or disease Intervention/treatment Phase
Fever Heart Rate, Fetal (FHR) Drug: Acetaminophen 975 mg Not Applicable

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), which is the designation for fetal heart rate abnormalities requiring cesarean delivery
  • 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%.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Study Start Date : July 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
Active Comparator: 2
Acetaminophen 975 mg once
 Drug: Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
Other Name: Tylenol


Outcome Measures
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Primary Outcome Measures :
  1. Maternal Body Temperature 90 Minutes After Randomization [ Time Frame: 90 minutes ]
    Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded.

  2. Baseline Fetal Heart Rate (FHR) After Treatment [ Time Frame: 90 minutes ]

Secondary Outcome Measures :
  1. Temperature Difference Before and After Treatment [ Time Frame: 90 minutes ]
    Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade

  2. Rate of Cesarean Delivery [ Time Frame: Labor--up to 24 hours ]
    Rate of cesarean delivery

  3. Rate of Determination of Non-reassuring Fetal Status [ Time Frame: Labor--up to 24 hours ]
    Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.

  4. Rate of Subsequent Development of Maternal Fever [ Time Frame: Labor--up to 24 hours ]
    Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.

  5. Rate of Diagnosis of Clinical Chorioamnionitis [ Time Frame: Labor--up to 24 hours ]
    Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.

  6. Rate of Neonatal Sepsis [ Time Frame: 7 days ]
    the number of participants who developed neonatal sepsis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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 or fetal heart rate abnormalities requiring cesarean delivery
  • Previous cesarean delivery
  • Multifetal gestation
  • Breech presentation
  • Known fetal anomaly
  • Known contraindication to vaginal delivery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377832


Locations
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United States, New York
New York Hospital Medical Center of Queens
Flushing, New York, United States, 11355
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Daniel W Skupski, MD Weill Medical College of Cornell University, New York Hospital Medical Center of Queens
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00377832    
Other Study ID Numbers: 0605008549
4730406 ( Other Identifier: New York Hospital Queens IRB )
First Posted: September 18, 2006    Key Record Dates
Results First Posted: September 16, 2013
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Weill Medical College of Cornell University:
Fetal tachycardia
Fever in labor
Acetaminophen
Non reassuring fetal status
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics