Trial Outcomes & Findings for Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial (NCT NCT00377832)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

90 minutes

Results posted on

2013-09-16

Participant Flow

Dates of recruitment 9/2006 until 12/2010 13 patients recruited No funding

All participants included in assigned groups

Participant milestones

Participant milestones
Measure	In Labor With a Fever Will Give no Medication	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Medication n=7 Participants	Acetaminophen 975 mg Once n=6 Participants	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	26.4 years STANDARD_DEVIATION 3.4 • n=5 Participants	26.1 years STANDARD_DEVIATION 4.6 • n=7 Participants	26.3 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Maternal Body Temperature 90 Minutes After Randomization	38 degrees centigrade Interval 37.3 to 38.5	37.4 degrees centigrade Interval 37.1 to 37.8

PRIMARY outcome

Timeframe: 90 minutes

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Baseline Fetal Heart Rate (FHR) After Treatment	167.6 beats per minute Standard Deviation 17.5	152.5 beats per minute Standard Deviation 9.4

SECONDARY outcome

Timeframe: 90 minutes

Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Temperature Difference Before and After Treatment	0.3 degrees Centigrade Interval -0.6 to 1.6	-0.15 degrees Centigrade Interval -0.4 to 0.1

SECONDARY outcome

Timeframe: Labor--up to 24 hours

Rate of cesarean delivery

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Rate of Cesarean Delivery	1 participants	2 participants

SECONDARY outcome

Timeframe: Labor--up to 24 hours

Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities.

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Rate of Determination of Non-reassuring Fetal Status	1 participants	2 participants

SECONDARY outcome

Timeframe: Labor--up to 24 hours

Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever.

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Rate of Subsequent Development of Maternal Fever	6 participants	2 participants

SECONDARY outcome

Timeframe: Labor--up to 24 hours

Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis.

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Rate of Diagnosis of Clinical Chorioamnionitis	1 participants	0 participants

SECONDARY outcome

Timeframe: 7 days

the number of participants who developed neonatal sepsis

Outcome measures

Outcome measures
Measure	In Labor With a Fever Will Give no Medication n=7 Participants	In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce n=6 Participants
Rate of Neonatal Sepsis	0 participants	0 participants

Adverse Events

No Medication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen 975 mg Once

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel W. Skupski, MD

Weill Cornell Medical College

Phone: 718-670-1495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place