Clinical trial NCT00377832: Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Official title: Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fever
Heart Rate, Fetal (FHR)
Keywords: Fetal tachycardia
Fever in labor
Acetaminophen
Non reassuring fetal status
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2006-09-18
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Maternal Body Temperature 90 Minutes After Randomization
timeFrame: 90 minutes
measure: Baseline Fetal Heart Rate (FHR) After Treatment
timeFrame: 90 minutes
Secondary outcomes:
measure: Temperature Difference Before and After Treatment
timeFrame: 90 minutes
measure: Rate of Cesarean Delivery
timeFrame: Labor--up to 24 hours
measure: Rate of Determination of Non-reassuring Fetal Status
timeFrame: Labor--up to 24 hours
measure: Rate of Subsequent Development of Maternal Fever
timeFrame: Labor--up to 24 hours
measure: Rate of Diagnosis of Clinical Chorioamnionitis
timeFrame: Labor--up to 24 hours
measure: Rate of Neonatal Sepsis
timeFrame: 7 days
Other outcomes:
Locations:
city: Flushing
country: United States
facility: New York Hospital Medical Center of Queens
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University, New York Hospital Medical Center of Queens
name: Daniel W Skupski, MD
role: PRINCIPAL_INVESTIGATOR
References: