Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Weill Medical College of Cornell University
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%.
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
