Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Infectious Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 10/2/2013 |
| Start Date: | July 2007 |
| End Date: | October 2011 |
| Contact: | Daniel W Skupski, MD |
| Email: | dwskupsk@med.cornell.edu |
| Phone: | 718-670-1495 |
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.
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%.
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
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