Wolfson Medical Center
Holon, Tel Aviv, 6997107, Israel
Location contact
Amihai Rottenstreich, MD
PRINCIPAL_INVESTIGATOR
Hagit Eisenberg, MD
CONTACT
Hagit Eisenberg, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06950840
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Phase 4
Holon, Tel Aviv, 6997107, Israel
Amihai Rottenstreich, MD
PRINCIPAL_INVESTIGATOR
Hagit Eisenberg, MD
CONTACT
Hagit Eisenberg, MD
PRINCIPAL_INVESTIGATOR
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. Management includes prompt antibiotic treatment and antipyretic use, particularly during labor, where maternal fever may contribute to fetal acidosis and increased risk of neonatal encephalopathy. Even in the absence of acidosis, maternal fever alone is linked to adverse neonatal outcomes. Antipyretics may also help resolve fetal tachycardia, potentially avoiding unnecessary cesarean sections. While both dipyrone and acetaminophen are considered safe, it remains unclear which has superior efficacy in the intrapartum setting, and an agent with faster onset may offer clinical advantages.
Stages of study: Following the diagnosis of suspected intrapartum intraamniotic infection, eligible women will be offered to participate. All women will be treated with the same broad-spectrum antibiotic regimen. As stated above, those who gave their informed consent will be randomly assigned to either dipyrone or acetaminophen.
After administering antipyretic treatment, oral temperature will be monitored every 5 minutes for up to 40 minutes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acetaminophen 1 g IV once
Dipyrone IV 1 g once
Time frame: 120 min
Time (minutes) from drug administration to temperature < 38 °C
Time frame: 120 min
Time to resolution of fetal tachycardia (min)
Time frame: From enrollment to delivery
Mode of delivery (vaginal / cesarean)
Time frame: At 1 and 5 minutes after birth
Apgar scores - Standard newborn assessment
Time frame: Immediately after birth
Neonatal arterial pH level
Contact information is provided by the study sponsor or research team.
Hagit Eisenberg, MD
CONTACT
Ilia Kleiner, MD
CONTACT
Wolfson Medical Center
Other Gov
Intravenous Dipyrone Compared With Intravenous Acetaminophen for Maternal Fever During Labor: A Randomised Controlled Trial
Acronym: PARADIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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