Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2006

Last Updated Date

September 8, 2008

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Maternal body temperature 90 minutes after treatment
Baseline FHR after treatment

Change History

Complete list of historical versions of study NCT00377832 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Official Title ^ICMJE

Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

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. 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)
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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Fever
Heart Rate, Fetal

Intervention ^ICMJE

Drug: Acetaminophen 975 mg

Study Arms / Comparison Groups

Active Comparator: Acetaminophen 975 mg once

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Daniel W Skupski, MD

718-670-1495

dwskupsk@med.cornell.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00377832

Responsible Party

Tina M. Calia, MA, Weill Medical College of Cornell University

Study ID Numbers ^ICMJE

0605008549, 4730406

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Daniel W Skupski, MD

Weill Medical College of Cornell University, New York Hospital Medical Center of Queens

Information Provided By

Weill Medical College of Cornell University

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP