Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

This study has been terminated.
(Poor recruitment and lack of funding)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00377832
First received: September 14, 2006
Last updated: September 5, 2013
Last verified: September 2013
  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 (FHR). 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 (FHR)
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:


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

Primary Outcome Measures:
  • Maternal Body Temperature 90 Minutes After Randomization [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Temperature Difference Before and After Treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade

  • Rate of Cesarean Delivery [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]
    Rate of cesarean delivery

  • Rate of Determination of Non-reassuring Fetal Status [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.

  • Rate of Neonatal Sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    the number of participants who developed neonatal sepsis


Enrollment: 13
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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), 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%.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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: 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
Results First Received: December 22, 2010
Last Updated: September 5, 2013
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on July 31, 2014