NCT00377832

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 16, 2013

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

3.4 years

First QC Date

September 14, 2006

Results QC Date

December 22, 2010

Last Update Submit

September 5, 2013

Conditions

FeverHeart Rate, Fetal (FHR)

Keywords

Fetal tachycardiaFever in laborAcetaminophenNon reassuring fetal status

Outcome Measures

Primary Outcomes (2)

  • 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.

    90 minutes

  • Baseline Fetal Heart Rate (FHR) After Treatment

    90 minutes

Secondary Outcomes (6)

  • Temperature Difference Before and After Treatment

    90 minutes

  • Rate of Cesarean Delivery

    Labor--up to 24 hours

  • Rate of Determination of Non-reassuring Fetal Status

    Labor--up to 24 hours

  • Rate of Subsequent Development of Maternal Fever

    Labor--up to 24 hours

  • Rate of Diagnosis of Clinical Chorioamnionitis

    Labor--up to 24 hours

  • +1 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

Acetaminophen 975 mg once

Drug: Acetaminophen 975 mg

Interventions

Acetaminophen 975 mgDRUG

Acetaminophen 975 mg by mouth once only

Also known as: Tylenol
2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnancy
  • Singleton pregnancy
  • Pregnancy with cephalic presentation
  • Pregnancy in active phase labor
  • Fetal tachycardia

You may not qualify if:

  • Acetaminophen allergy
  • Clinical chorioamnionitis
  • Maternal fever
  • Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
  • Previous cesarean delivery
  • Multifetal gestation
  • Breech presentation
  • Known fetal anomaly
  • Known contraindication to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hospital Medical Center of Queens

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

Fever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Poor recruitment and lack of funding led to early termination of the trial

Results Point of Contact

Title
Daniel W. Skupski, MD
Organization
Weill Cornell Medical College
dwskupsk@med.cornell.edu
718-670-1495

Study Officials

  • Daniel W Skupski, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 18, 2006

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 16, 2013

Results First Posted

September 16, 2013

Record last verified: 2013-09

Locations

US(1)