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Clinical Trials in Israel / NCT06950840
Starting soon Phase 4

Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)

NCT06950840 · tracked via the Priya Life Science Israel tracker
Phase
Phase 4
Started
2025-08-01
Last updated
2025-07-03

Condition(s) studied

Intrapartum FeverChorioamnionitis

Investigational drug(s) / intervention(s)

Acetaminophen →dipyrone

Acetaminophen: Acetaminophen 1 g IV once

dipyrone: Dipyrone IV 1 g once

Study summary

Chorioamnionitis, or intraamniotic infection, is a common condition affecting 2-5% of all term births. This condition poses well-recognized maternal and neonatal risks, and entails a series of clinical management decisions concerning both the mother and neonate. Therefore, timely detection and treatment of chorioamnionitis is of paramount importance. The occurrence of chorioamnionitis is associated with a higher risk of labor abnormalities, which increase the risk of cesarean delivery (CD) 3 to 4 fold.

As recommended by current guidelines, treatment of suspected intraamniotic infection should include broad-spectrum antibiotics. In addition, the use of antipyretics is advocated. This is particularly important during the intrapartum period since fetal acidosis in the setting of fever has been associated with a marked increase in the incidence of neonatal encephalopathy. Maternal fever even in the absence of documented fetal acidosis is associated with adverse neonatal outcomes, particularly neonatal encephalopathy, though it is unclear to what extent the etiology of the fever rather than the fever itself is causative . Furthermore, treating intrapartum fever with antipyretics may also be helpful in reducing fetal tachycardia thereby avoiding the tendency to perform cesarean for a non-reassuring fetal status. Nevertheless, it remains understudied which is the most appropriate antipyretic agent in this regard, where both dipyrone and acetaminophen are safe alternatives . Antipyretic agent with a faster onset of action may be preferable in this setting.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women undergoing a trial of vaginal delivery, with suspected intra-amniotic infection defined as isolated maternal fever of 39°C or greater, or an sustained oral temperature of 38-38.9°C for at least 30 minutes or with one or more of the following: maternal leukocytosis, purulent cervical drainage, or fetal tachycardia. Exclusion Criteria: * Known history of adverse events for dipyrone or acetaminophen * Age \<18 years * Gestational age \<24 weeks * Intrauterine fetal death * Fever onset prior to delivery * Known liver disease * Known leukopenia * In addition, those who will develop allergic event or any adverse event possible related to any of the antipyretics used will be excluded from the

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wolfson Medical Center Holon Tel Aviv

On this site

📄 Tylenol (acetaminophen) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06950840 on ClinicalTrials.gov ↗ ← All trials in Israel