Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Condition(s) targeted: Fever; Heart Rate, Fetal

Intervention: Acetaminophen 975 mg (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Daniel W Skupski, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University, New York Hospital Medical Center of Queens

Overall contact:
Daniel W Skupski, MD, Phone: 718-670-1495, Email: dwskupsk@med.cornell.edu

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. The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.

Official title: Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Maternal body temperature 90 minutes after treatment

Baseline FHR after treatment

Secondary outcome:

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

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)

- 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%.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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 requiring cesarean delivery

- Previous cesarean delivery

- Multifetal gestation

- Breech presentation

- Known fetal anomaly

- Known contraindication to vaginal delivery

Daniel W Skupski, MD, Phone: 718-670-1495, Email: dwskupsk@med.cornell.edu

New York Hospital Medical Center of Queens, Flushing, New York 11355, United States; Recruiting
Daniel W Skupski, MD, Principal Investigator

Starting date: July 2007
Ending date: October 2011
Last updated: September 8, 2008