Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Fever Clinical Trial

Official title:

Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00377832
• Other study ID #: 0605008549
• Secondary ID: 4730406
• Status: Terminated
• Phase: N/A
• First received: September 14, 2006
• Last updated: September 5, 2013
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Heart Rate, Fetal (FHR)
• Tachycardia

Intervention

Drug:
• Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only

Locations

Country	Name	City	State
United States	New York Hospital Medical Center of Queens	Flushing	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Baseline Fetal Heart Rate (FHR) After Treatment		90 minutes	No
Secondary	Temperature Difference Before and After Treatment	Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade	90 minutes	No
Secondary	Rate of Cesarean Delivery	Rate of cesarean delivery	Labor--up to 24 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Rate of Neonatal Sepsis	the number of participants who developed neonatal sepsis	7 days	No