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| ID | Type | Description | Link |
|---|---|---|---|
| 4730406 | Other Identifier | New York Hospital Queens IRB |
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Poor recruitment and lack of funding
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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.
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:
Primary outcome measures are:
Secondary outcome measures are:
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | ||
| 2 | Active Comparator | Acetaminophen 975 mg once |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen 975 mg | Drug | Acetaminophen 975 mg by mouth once only |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 minutes |
| Baseline Fetal Heart Rate (FHR) After Treatment | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature Difference Before and After Treatment | Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade | 90 minutes |
| Rate of Cesarean Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel W Skupski, MD | Weill Medical College of Cornell University, New York Hospital Medical Center of Queens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Hospital Medical Center of Queens | Flushing | New York | 11355 | United States |
All participants included in assigned groups
Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding
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| ID | Title | Description |
|---|---|---|
| FG000 | In Labor With a Fever Will Give no Medication | |
| FG001 | In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Medication | |
| BG001 | Acetaminophen 975 mg Once | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | degrees centigrade | 90 minutes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Medication | In labor, fever is identified, consent and randomization occurs, then no medication is given. |
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Poor recruitment and lack of funding led to early termination of the trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel W. Skupski, MD | Weill Cornell Medical College | 718-670-1495 | dwskupsk@med.cornell.edu |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Rate of cesarean delivery
| Labor--up to 24 hours |
| 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. | Labor--up to 24 hours |
| Rate of Subsequent Development of Maternal Fever | Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever. | Labor--up to 24 hours |
| Rate of Diagnosis of Clinical Chorioamnionitis | Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis. | Labor--up to 24 hours |
| Rate of Neonatal Sepsis | the number of participants who developed neonatal sepsis | 7 days |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Baseline Fetal Heart Rate (FHR) After Treatment | Posted | Mean | Standard Deviation | beats per minute | 90 minutes |
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| Secondary | Temperature Difference Before and After Treatment | Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade | Posted | Median | Inter-Quartile Range | degrees Centigrade | 90 minutes |
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| Secondary | Rate of Cesarean Delivery | Rate of cesarean delivery | Posted | Number | participants | Labor--up to 24 hours |
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| 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. | Posted | Number | participants | Labor--up to 24 hours |
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| Secondary | Rate of Subsequent Development of Maternal Fever | Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever. | Posted | Number | participants | Labor--up to 24 hours |
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| Secondary | Rate of Diagnosis of Clinical Chorioamnionitis | Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis. | Posted | Number | participants | Labor--up to 24 hours |
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| Secondary | Rate of Neonatal Sepsis | the number of participants who developed neonatal sepsis | Posted | Number | participants | 7 days |
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| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Acetaminophen 975 mg Once | In labor, fever is identified, consent and randomization occurs, then acetaminophen is given. | 0 | 6 | 0 | 6 |
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| Aniline Compounds |
| D000588 | Amines |