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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

Tracking Information
First Submitted Date  ICMJE September 14, 2006
First Posted Date  ICMJE September 18, 2006
Results First Submitted Date  ICMJE December 22, 2010
Results First Posted Date  ICMJE September 16, 2013
Last Update Posted Date September 16, 2013
Study Start Date  ICMJE July 2007
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • 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.
  • Baseline Fetal Heart Rate (FHR) After Treatment [ Time Frame: 90 minutes ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
  • Maternal body temperature 90 minutes after treatment
  • Baseline FHR after treatment
Change History Complete list of historical versions of study NCT00377832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Temperature Difference Before and After Treatment [ Time Frame: 90 minutes ]
    Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade
  • Rate of Cesarean Delivery [ Time Frame: Labor--up to 24 hours ]
    Rate of cesarean delivery
  • 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.
  • 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.
  • 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.
  • Rate of Neonatal Sepsis [ Time Frame: 7 days ]
    the number of participants who developed neonatal sepsis
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Official Title  ICMJE Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fever
  • Heart Rate, Fetal (FHR)
Intervention  ICMJE Drug: Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
Other Name: Tylenol
Study Arms  ICMJE
  • No Intervention: 1
  • Active Comparator: 2
    Acetaminophen 975 mg once
    Intervention: Drug: Acetaminophen 975 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 5, 2013)
13
Original Enrollment  ICMJE
 (submitted: September 14, 2006)
54
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377832
Other Study ID Numbers  ICMJE 0605008549
4730406 ( Other Identifier: New York Hospital Queens IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel W Skupski, MD Weill Medical College of Cornell University, New York Hospital Medical Center of Queens
PRS Account Weill Medical College of Cornell University
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP