Intrapartum FeverPhase 4PARADIPNCT06950840
Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)
A Phase 4 study testing Acetaminophen and dipyrone in people with Intrapartum Fever and Chorioamnionitis, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrapartum Fever, Chorioamnionitis
- What is being tested?
- Acetaminophen and dipyrone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2025to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Wolfson Medical Center
Holon, Tel Aviv, 6997107
Hagit Eisenberg, MD, +972523397843, hagit.haramati@gmail.com
Hagit Eisenberg, MD
About this study
Official title: Intravenous Dipyrone Compared With Intravenous Acetaminophen for Maternal Fever During Labor: A Randomised Controlled 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.
Read the 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. 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.
- Conditions
- Intrapartum Fever, Chorioamnionitis
- Being tested
- Acetaminophen, dipyrone
- Keywords
- maternal fever, labour, acetaminophen, dipyrone, metamizole
- Medical subject headings
- Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Acetaminophen 1 g IV once
dipyroneDrug
Dipyrone IV 1 g once
| Study group | Role | What they receive |
|---|---|---|
| Dipyrone | Experimental | Dipyrone IV 1 g once Receives: Drug: dipyrone |
| Acetaminophen | Experimental | Acetaminophen 1 g IV once Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to defervesce
Time (minutes) from drug administration to temperature < 38 °C
Measured: 120 min
Secondary outcomes (4)
Time to resolution of fetal tachycardia
Time to resolution of fetal tachycardia (min)
Measured: 120 min
Mode of delivery
Mode of delivery (vaginal / cesarean)
Measured: From enrollment to delivery
Apgar scores
Apgar scores - Standard newborn assessment
Measured: At 1 and 5 minutes after birth
Neonatal arterial pH level
Neonatal arterial pH level
Measured: Immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrapartum FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ilia kleiner, Wolfson Medical Center
- Investigators
- Ilia Kleiner, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950840
- Sponsor's protocol ID
- WOMC-0093-25
- Acronym
- PARADIP
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Time to defervescence, fetal heart rate response, delivery mode, Apgar scores, neonatal pH
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dipyrone Compared With Intravenous Acetaminophen for Maternal Fever During Labor: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06950840
- Acronym / sponsor ID
- PARADIP / WOMC-0093-25
- Conditions
- Intrapartum Fever, Chorioamnionitis
- Keywords
- maternal fever, labour, acetaminophen, dipyrone, metamizole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipyrone | Experimental | Drug: dipyroneDipyrone IV 1 g once |
| Acetaminophen | Experimental | Drug: AcetaminophenAcetaminophen 1 g IV once |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- Known history of adverse events for dipyrone or acetaminophen
- Age <18 years
- Gestational age <24 weeks
- Intrauterine fetal death
- Fever onset prior to delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAcetaminophen 1 g IV once | Drug | Acetaminophen |
| dipyroneDipyrone IV 1 g once | Drug | Dipyrone |
Primary outcome
Time to defervesce
Time frame: 120 min
Time (minutes) from drug administration to temperature < 38 °C
4 secondary outcomes
Time to resolution of fetal tachycardia
Time frame: 120 min
Mode of delivery
Time frame: From enrollment to delivery
Apgar scores
Time frame: At 1 and 5 minutes after birth
Neonatal arterial pH level
Time frame: Immediately after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes. Time to defervescence, fetal heart rate response, delivery mode, Apgar scores, neonatal pH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilia Kleiner, MD principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and dipyrone in people with Intrapartum Fever and Chorioamnionitis, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagit Eisenberg, MD (+972523397843, hagit.haramati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to defervesce (time frame: 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.