Fever, Heart Rate, Fetal (FHR)
Conditions
Keywords
Fetal tachycardia, Fever in labor, Acetaminophen, Non reassuring fetal status
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%.
Interventions
DRUGAcetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Body Temperature 90 Minutes After Randomization | 90 minutes | 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 | 90 minutes | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Determination of Non-reassuring Fetal Status | Labor--up to 24 hours | 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 | Labor--up to 24 hours | Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever. |
| Temperature Difference Before and After Treatment | 90 minutes | Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade |
| Rate of Neonatal Sepsis | 7 days | the number of participants who developed neonatal sepsis |
| Rate of Diagnosis of Clinical Chorioamnionitis | Labor--up to 24 hours | Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis. |
| Rate of Cesarean Delivery | Labor--up to 24 hours | Rate of cesarean delivery |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding
Pre-assignment details
All participants included in assigned groups
Participants by arm
| Arm | Count |
|---|---|
| No Medication | 7 |
| Acetaminophen 975 mg Once | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Acetaminophen 975 mg Once | No Medication | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Age Continuous | 26.1 years STANDARD_DEVIATION 4.6 | 26.4 years STANDARD_DEVIATION 3.4 | 26.3 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment United States | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Baseline Fetal Heart Rate (FHR) After Treatment
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In Labor With a Fever Will Give no Medication | Baseline Fetal Heart Rate (FHR) After Treatment | 167.6 beats per minute | Standard Deviation 17.5 |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Baseline Fetal Heart Rate (FHR) After Treatment | 152.5 beats per minute | Standard Deviation 9.4 |
Primary
Maternal Body Temperature 90 Minutes After Randomization
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.
Time frame: 90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Maternal Body Temperature 90 Minutes After Randomization | 38 degrees centigrade |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Maternal Body Temperature 90 Minutes After Randomization | 37.4 degrees centigrade |
Secondary
Rate of Cesarean Delivery
Rate of cesarean delivery
Time frame: Labor--up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Rate of Cesarean Delivery | 1 participants |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Rate of Cesarean Delivery | 2 participants |
Secondary
Rate of Determination of Non-reassuring Fetal Status
Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.
Time frame: Labor--up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Rate of Determination of Non-reassuring Fetal Status | 1 participants |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Rate of Determination of Non-reassuring Fetal Status | 2 participants |
Secondary
Rate of Diagnosis of Clinical Chorioamnionitis
Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.
Time frame: Labor--up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Rate of Diagnosis of Clinical Chorioamnionitis | 1 participants |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Rate of Diagnosis of Clinical Chorioamnionitis | 0 participants |
Secondary
Rate of Neonatal Sepsis
the number of participants who developed neonatal sepsis
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Rate of Neonatal Sepsis | 0 participants |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Rate of Neonatal Sepsis | 0 participants |
Secondary
Rate of Subsequent Development of Maternal Fever
Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.
Time frame: Labor--up to 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Rate of Subsequent Development of Maternal Fever | 6 participants |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Rate of Subsequent Development of Maternal Fever | 2 participants |
Secondary
Temperature Difference Before and After Treatment
Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade
Time frame: 90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In Labor With a Fever Will Give no Medication | Temperature Difference Before and After Treatment | 0.3 degrees Centigrade |
| In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce | Temperature Difference Before and After Treatment | -0.15 degrees Centigrade |