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Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

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ClinicalTrials.gov Identifier: NCT00377832
Recruitment Status : Terminated (Poor recruitment and lack of funding)
First Posted : September 18, 2006
Results First Posted : September 16, 2013
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fever
Heart Rate, Fetal (FHR)
Intervention Drug: Acetaminophen 975 mg
Enrollment 13
Recruitment Details Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding
Pre-assignment Details All participants included in assigned groups
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title No Medication Acetaminophen 975 mg Once Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
26.4  (3.4) 26.1  (4.6) 26.3  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
7
 100.0%
6
 100.0%
13
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7 6 13
1.Primary Outcome
Title Maternal Body Temperature 90 Minutes After Randomization
Hide Description 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.
Time Frame 90 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Median (Inter-Quartile Range)
Unit of Measure: degrees centigrade
38
(37.3 to 38.5)
37.4
(37.1 to 37.8)
2.Primary Outcome
Title Baseline Fetal Heart Rate (FHR) After Treatment
Hide Description [Not Specified]
Time Frame 90 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Medication Acetaminophen 975 mg Once
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: beats per minute
167.6  (17.5) 152.5  (9.4)
3.Secondary Outcome
Title Temperature Difference Before and After Treatment
Hide Description Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade
Time Frame 90 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Median (Inter-Quartile Range)
Unit of Measure: degrees Centigrade
0.3
(-0.6 to 1.6)
-0.15
(-0.4 to 0.1)
4.Secondary Outcome
Title Rate of Cesarean Delivery
Hide Description Rate of cesarean delivery
Time Frame Labor--up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
1 2
5.Secondary Outcome
Title Rate of Determination of Non-reassuring Fetal Status
Hide Description Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.
Time Frame Labor--up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
1 2
6.Secondary Outcome
Title Rate of Subsequent Development of Maternal Fever
Hide Description Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.
Time Frame Labor--up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
6 2
7.Secondary Outcome
Title Rate of Diagnosis of Clinical Chorioamnionitis
Hide Description Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.
Time Frame Labor--up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Get no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
1 0
8.Secondary Outcome
Title Rate of Neonatal Sepsis
Hide Description the number of participants who developed neonatal sepsis
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In Labor With a Fever Will Give no Medication In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Medication Acetaminophen 975 mg Once
Hide Arm/Group Description In labor, fever is identified, consent and randomization occurs, then no medication is given. In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
All-Cause Mortality
No Medication Acetaminophen 975 mg Once
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Medication Acetaminophen 975 mg Once
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
No Medication Acetaminophen 975 mg Once
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%) 
Poor recruitment and lack of funding led to early termination of the trial
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel W. Skupski, MD
Organization: Weill Cornell Medical College
Phone: 718-670-1495
EMail: dwskupsk@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00377832     History of Changes
Other Study ID Numbers: 0605008549
4730406 ( Other Identifier: New York Hospital Queens IRB )
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: December 22, 2010
Results First Posted: September 16, 2013
Last Update Posted: September 16, 2013