A Phase 4 interventional study of Acetaminophen and dipyrone in Intrapartum Fever and Chorioamnionitis, sponsored by Wolfson Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Wolfson Medical Center · Phase 4, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's planned enrollment of 140 is below the median of 157 across 22 interventional studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Dipyrone IV 1 g once
Drug: dipyrone
Acetaminophen 1 g IV once
Drug: Acetaminophen
Acetaminophen 1 g IV once
Dipyrone IV 1 g once
Time to defervesce
Time (minutes) from drug administration to temperature \< 38 °C
Time frame: 120 min
Time to resolution of fetal tachycardia
Time to resolution of fetal tachycardia (min)
Time frame: 120 min
Mode of delivery
Mode of delivery (vaginal / cesarean)
Time frame: From enrollment to delivery
Apgar scores
Apgar scores - Standard newborn assessment
Time frame: At 1 and 5 minutes after birth
Neonatal arterial pH level
Neonatal arterial pH level
Time frame: Immediately after birth
Plan to share: Yes — Time to defervescence, fetal heart rate response, delivery mode, Apgar scores, neonatal pH
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 6 months after study completion; available for 2 years
Access criteria: Qualified researchers with institutional ethics approval will be able to access de-identified individual participant data, including time to fever resolution, fetal heart rate response, delivery mode, Apgar scores, and neonatal arterial pH. Data will be available upon reasonable request to the Principal Investigator via email. Requests must include a brief study proposal and evidence of ethical approval. If approved, data will be shared in a secure, password-protected format. Supporting documents such as the study protocol and statistical analysis plan will also be made available upon request.
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for May 2027, 21 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Dipyrone