Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Recruitment status was Recruiting
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Purpose
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. The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.
| Condition | Intervention |
|---|---|
|
Fever Heart Rate, Fetal |
Drug: Acetaminophen 975 mg |
| Study Type: | Interventional |
| 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 treatment [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
- Baseline 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 ]
- Rate of cesarean delivery [ Time Frame: Labor ] [ Designated as safety issue: No ]
- Rate of determination of NRFS [ Time Frame: Labor ] [ Designated as safety issue: No ]
- Rate of subsequent development of maternal fever [ Time Frame: Labor ] [ Designated as safety issue: No ]
- Rate of diagnosis of clinical chorioamnionitis [ Time Frame: Labor ] [ Designated as safety issue: No ]
- Rate of neonatal sepsis [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 1 | |
|
Active Comparator: 2
Acetaminophen 975 mg once
|
Drug: Acetaminophen 975 mg
Acetaminophen 975 mg by mouth once only
Other Name: Tylenol
|
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)
- 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%.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts 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 requiring cesarean delivery
- Previous cesarean delivery
- Multifetal gestation
- Breech presentation
- Known fetal anomaly
- Known contraindication to vaginal delivery
Contacts and Locations| Contact: Daniel W Skupski, MD | 718-670-1495 | dwskupsk@med.cornell.edu |
| United States, New York | |
| New York Hospital Medical Center of Queens | Recruiting |
| Flushing, New York, United States, 11355 | |
| Principal Investigator: Daniel W Skupski, MD | |
| Principal Investigator: | Daniel W Skupski, MD | Weill Medical College of Cornell University, New York Hospital Medical Center of Queens |
More Information
No publications provided
| Responsible Party: | Tina M. Calia, MA, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00377832 History of Changes |
| Other Study ID Numbers: | 0605008549, 4730406 |
| Study First Received: | September 14, 2006 |
| Last Updated: | September 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
Fetal tachycardia Fever in labor Acetaminophen Non reassuring fetal status |
Additional relevant MeSH terms:
|
Fever Tachycardia Body Temperature Changes Signs and Symptoms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Acetaminophen |
Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013