Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial|
- Maternal Body Temperature 90 Minutes After Randomization [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]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.
- Baseline Fetal Heart Rate (FHR) After Treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
- Temperature Difference Before and After Treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade
- Rate of Cesarean Delivery [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]Rate of cesarean delivery
- Rate of Determination of Non-reassuring Fetal Status [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.
- Rate of Subsequent Development of Maternal Fever [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.
- Rate of Diagnosis of Clinical Chorioamnionitis [ Time Frame: Labor--up to 24 hours ] [ Designated as safety issue: No ]Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.
- Rate of Neonatal Sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]the number of participants who developed neonatal sepsis
|Study Start Date:||July 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|No Intervention: 1|
Active Comparator: 2
Acetaminophen 975 mg once
Drug: Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
Other Name: Tylenol
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:
- Maternal body temperature (oral) 90 minutes after treatment
- Baseline FHR
Secondary outcome measures are:
- 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
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377832
|United States, New York|
|New York Hospital Medical Center of Queens|
|Flushing, New York, United States, 11355|
|Principal Investigator:||Daniel W Skupski, MD||Weill Medical College of Cornell University, New York Hospital Medical Center of Queens|