Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-29 @ 8:07 AM
Study NCT ID:
NCT00377832
Status:
TERMINATED
Last Update Posted:
2013-09-16
First Post:
2006-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment and lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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%.
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%.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4730406 | OTHER | New York Hospital Queens IRB | View |