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

NCT06950840 | Not Yet Recruiting Phase 4

• 1 other identifier: WOMC-0093-25
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intrapartum Fever; Chorioamnionitis

Keywords

maternal fever; labour; acetaminophen; dipyrone; metamizole

Outcome Measures

Primary Outcomes (1)

• Time to defervesce

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

  120 min

Secondary Outcomes (4)

• Time to resolution of fetal tachycardia

  120 min

• Mode of delivery

  From enrollment to delivery

• Apgar scores

  At 1 and 5 minutes after birth

• Neonatal arterial pH level

  Immediately after birth

Study Arms (2)

Dipyrone

EXPERIMENTAL

Dipyrone IV 1 g once

Drug: dipyrone

Acetaminophen

EXPERIMENTAL

Acetaminophen 1 g IV once

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Acetaminophen 1 g IV once

Acetaminophen

dipyrone DRUG

Dipyrone IV 1 g once

Dipyrone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified women who are pregnant and meet inclusion criteria for suspected intra-amniotic infection during labor.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Tel Aviv, 6997107, Israel

Location

MeSH Terms

Conditions

Chorioamnionitis

Interventions

Acetaminophen; Dipyrone

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ilia Kleiner, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hagit Eisenberg, MD

CONTACT

+972523397843; hagit.haramati@gmail.com

Ilia Kleiner, MD

CONTACT

+972528305195; kleiner.ilia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Obstetrician & Gynecologist; Director of Labor-and-Delivery Rooms and the Maternity Department

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

IL (1)