FeverNCT00377832
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
A study testing Acetaminophen 975 mg in people with Fever and Heart Rate, Fetal (FHR), run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fever, Heart Rate, Fetal (FHR)
- What is being tested?
- Acetaminophen 975 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Term pregnancy
- Singleton pregnancy
- Pregnancy with cephalic presentation
- Pregnancy in active phase labor
- Fetal tachycardia
Who cannot join
- Acetaminophen allergy
- Clinical chorioamnionitis
- Maternal fever
- Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
- Previous cesarean delivery
- Multifetal gestation
Show all 9Show fewer
- Breech presentation
- Known fetal anomaly
- Known contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Hospital Medical Center of Queens
Flushing, New York, 11355
About this study
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.
Read the 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:
- 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%.
- Conditions
- Fever, Heart Rate, Fetal (FHR)
- Being tested
- Acetaminophen 975 mg
- Keywords
- Fetal tachycardia, Fever in labor, Acetaminophen, Non reassuring fetal status
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 975 mgDrug
Also called Tylenol
Acetaminophen 975 mg by mouth once only
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | Acetaminophen 975 mg once Receives: Drug: Acetaminophen 975 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Baseline Fetal Heart Rate (FHR) After Treatment
Measured: 90 minutes
Secondary outcomes (6)
Temperature Difference Before and After Treatment
Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade
Measured: 90 minutes
Rate of Cesarean Delivery
Rate of cesarean delivery
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Labor--up to 24 hours
Rate of Neonatal Sepsis
the number of participants who developed neonatal sepsis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Poor recruitment and lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel W Skupski, MD, Principal investigator, Weill Medical College of Cornell University, New York Hospital Medical Center of Queens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377832
- Sponsor's protocol ID
- 0605008549
- Other IDs
- 4730406
- Status last verified
- Sep 2013
- First submitted
- 14 Sep 2006
- Last updated
- 16 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT00377832
- Acronym / sponsor ID
- 0605008549
- Conditions
- Fever, Heart Rate, Fetal (FHR)
- Keywords
- Fetal tachycardia, Fever in labor, Acetaminophen, Non reassuring fetal status
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment and lack of funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Posted 16 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Drug: Acetaminophen 975 mgAcetaminophen 975 mg once |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Term pregnancy
- Singleton pregnancy
- Pregnancy with cephalic presentation
- Pregnancy in active phase labor
- Fetal tachycardia
Key exclusion criteria (9 listed)
- Acetaminophen allergy
- Clinical chorioamnionitis
- Maternal fever
- Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
- Previous cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen 975 mgAlso: TylenolAcetaminophen 975 mg by mouth once only | Drug | 2 |
Primary outcome
Maternal Body Temperature 90 Minutes After Randomization
Time frame: 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
Time frame: 90 minutes
6 secondary outcomes
Temperature Difference Before and After Treatment
Time frame: 90 minutes
Rate of Cesarean Delivery
Time frame: Labor--up to 24 hours
Rate of Determination of Non-reassuring Fetal Status
Time frame: Labor--up to 24 hours
Rate of Subsequent Development of Maternal Fever
Time frame: Labor--up to 24 hours
Rate of Diagnosis of Clinical Chorioamnionitis
Time frame: Labor--up to 24 hours
Rate of Neonatal Sepsis
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Skupski, MD principal investigator
Weill Medical College of Cornell University, New York Hospital Medical Center of Queens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen 975 mg in people with Fever and Heart Rate, Fetal (FHR), run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Body Temperature 90 Minutes After Randomization (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.