Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

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.

Study Overview

• Status: Terminated
• Conditions: Fever; Heart Rate, Fetal (FHR)
• Intervention / Treatment: Drug: Acetaminophen 975 mg

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: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Flushing, New York, United States, 11355
      • New York Hospital Medical Center of Queens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Body Temperature 90 Minutes After Randomization	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.	90 minutes
Baseline Fetal Heart Rate (FHR) After Treatment		90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature Difference Before and After Treatment	Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade	90 minutes
Rate of Cesarean Delivery	Rate of cesarean delivery	Labor--up to 24 hours
Rate of Determination of Non-reassuring Fetal Status	Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.	Labor--up to 24 hours
Rate of Subsequent Development of Maternal Fever	Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.	Labor--up to 24 hours
Rate of Diagnosis of Clinical Chorioamnionitis	Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.	Labor--up to 24 hours
Rate of Neonatal Sepsis	the number of participants who developed neonatal sepsis	7 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 14, 2006
• First Submitted That Met QC Criteria: September 14, 2006
• First Posted (Estimate): September 18, 2006

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Acetaminophen; Fetal tachycardia; Fever in labor; Non reassuring fetal status
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 0605008549; 4730406 (Other Identifier: New York Hospital Queens IRB)