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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWolfson Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known history of adverse events for dipyrone or acetaminophen

Age <18 years

Gestational age <24 weeks

Intrauterine fetal death

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen

    Drug

    Acetaminophen 1 g IV once

  • dipyrone

    Drug

    Dipyrone IV 1 g once

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: DipyroneExperimental treatment 1 intervention
Group B: AcetaminophenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time to defervesce

Time (minutes) from drug administration to temperature \< 38 °C

Time frame
120 min

Secondary outcomes

1

Time to resolution of fetal tachycardia

Time to resolution of fetal tachycardia (min)

Time frame
120 min
2

Mode of delivery

Mode of delivery (vaginal / cesarean)

Time frame
From enrollment to delivery
3

Apgar scores

Apgar scores - Standard newborn assessment

Time frame
At 1 and 5 minutes after birth
4

Neonatal arterial pH level

Neonatal arterial pH level

Time frame
Immediately after birth

Other outcomes

Sponsors and contacts

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