Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

NCT ID: NCT00377832

Last Updated: 2013-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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%.

Conditions

Fever; Heart Rate, Fetal (FHR)

Keywords

Fetal tachycardia; Fever in labor; Acetaminophen; Non reassuring fetal status

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Acetaminophen 975 mg once

Group Type: ACTIVE_COMPARATOR

Acetaminophen 975 mg

Intervention Type: DRUG

Acetaminophen 975 mg by mouth once only

Interventions

Acetaminophen 975 mg

Acetaminophen 975 mg by mouth once only

Intervention Type: DRUG

Other Intervention Names

Tylenol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel W Skupski, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University, New York Hospital Medical Center of Queens

Locations

New York Hospital Medical Center of Queens

Flushing, New York, United States

Countries

United States

Other Identifiers

4730406

Identifier Type: OTHER

Identifier Source: secondary_id

0605008549

Identifier Type: -

Identifier Source: org_study_id