Status:
NOT_YET_RECRUITING
Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)
Lead Sponsor:
Wolfson Medical Center
Conditions:
Intrapartum Fever
Chorioamnionitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 clinica...
Detailed Description
Chorioamnionitis, or intraamniotic infection, affects 2-5% of term deliveries and is associated with significant maternal and neonatal risks, including a 3- to 4-fold increase in cesarean delivery. Ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06950840
Start Date
August 1 2025
End Date
May 1 2027
Last Update
July 3 2025
Active Locations (1)
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1
Wolfson Medical Center
Holon, Tel Aviv, Israel, 6997107