Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Fever; Heart Rate, Fetal (FHR)

Treatments: Drug: Acetaminophen 975 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00377832

4730406 (Other Identifier)

0605008549

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 or fetal heart rate abnormalities requiring cesarean delivery
• Previous cesarean delivery
• Multifetal gestation
• Breech presentation
• Known fetal anomaly
• Known contraindication to vaginal delivery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

1

No Intervention group

2

Active Comparator group

Description:

Acetaminophen 975 mg once

Treatment:

Drug: Acetaminophen 975 mg