Postpartum InfectionNCT06760130
Retrospective Evaluation of Infections After Delivery
An observational study of Postpartum Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
In general, transabdominal and transvaginal ultrasound represent the first imaging method in the study of suspected postpartum infections because of its good sensitivity, low cost, and high safety for patients (in fact, it allows the patient to be studied at the bedside, even in clinically unstable patients, it is… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Infection
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2025to 31 Dec 2026
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: It is planned to enroll patients who gave birth at the Operative Unit of Obstetrics and Prenatal Age Medicine of IRCCS AOUBO Policlinico di Sant'Orsola from 01/01/2017 to 31/12/2021.
Who may be able to join
- Women aged 18 years or older
- Diagnosis of postpartum infection (within 30 days after delivery).
- Clinical diagnosis is established by the following criteria (two or more of the following):
- Temperature >38°C or <36°C
- HR >100 bpm
- FR >20 respiratory acts/min or PaCO2 <32mmHg
Show all 12Show fewer
- GB >14 x 109/dL or <4 x 109/dL
- EGA: lactates >2mmol/L (or 18 mg/dL)
- PCR >2DS from normal value
- Procalcitonin >2DS from normal value or positive laboratory culture result for the presence of bacteria (urinoculture, peritoneal fluid culture, abscess...).
- obtaining informed consent
- Women who have had at least one ultrasound (transabdominal and/or transvaginal) and one CT scan for suspected postpartum infection
Who cannot join
- Women with localized or systemic infection following infection unrelated to delivery or incision site (in case of cesarean section), such as pneumonia, mastitis, influenza, COVID-19.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
In general, transabdominal and transvaginal ultrasound represent the first imaging method in the study of suspected postpartum infections because of its good sensitivity, low cost, and high safety for patients (in fact, it allows the patient to be studied at the bedside, even in clinically unstable patients, it is well tolerated by patients, and it has no risks). CT has an excellent sensitivity in the diagnosis of postpartum infections, however, it has some drawbacks: it is not an examination that can be performed in clinically unstable patients, it cannot be performed at the patient's bedside, it has high costs, and it involves the administration of a significant dose of radiation . There are conflicting data in the literature regarding which examination is most useful for the diagnosis/management of infections in postpartum. Therefore, the investigators want to evaluate whether ultrasound alone, compared with management with combined ultrasound and CT scan, is a useful and sufficient diagnostic tool for the diagnosis and management of postpartum infectious complications.
Read the detailed description
Cases of infection recorded as a result of these parts will be reviewed. Laboratory tests and clinical data of these will be reviewed. Instrumental, ultrasound and CT images taken in the postpartum for diagnostic confirmation and subsequent follow-up will also be reviewed.
For each patient, information will be collected on:
- Age, weight, height
- Previous pregnancies and their outcome
- Pregnancy that arose spontaneously or through Medically Assisted Procreation techniques
- Conditions concomitant or complicating pregnancy
- Pregnancy outcome (spontaneous delivery or cesarean section)
- Laboratory tests
- Clinical data collected during hospitalization (vital parameters, symptoms, any medications administered)
- Radiologic (CT) or ultrasound (transabdominal and/or transvaginal) investigations performed during the hospital stay, in continuation-iter or in a subsequent hospitalization: name and model (and probe, for ultrasound examinations) of the equipment used will be specified for each examination performed.
- Conditions
- Postpartum Infection
- Keywords
- ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of ultrasound signs of infection on ultrasonography
Presence of a hypoanechogenic area at the fascial level or hyperechogenic echoes at the level of the endometrial cavity. Ultrasound signs will be compared with CT scans of patients with established postpartum infection. CT scans are currently the gold standard for the diagnosis of infection, and investigators will rely on what is in the report in the medical record.
Measured: Within 90 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study startJan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum InfectionStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Brunelli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760130
- Sponsor's protocol ID
- INFPP_2022
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Infections After Delivery
- ClinicalTrials.gov ID
- NCT06760130
- Acronym / sponsor ID
- INFPP_2022
- Conditions
- Postpartum Infection
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 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.
In general, transabdominal and transvaginal ultrasound represent the first imaging method in the study of suspected postpartum infections because of its good sensitivity, low cost, and high safety for patients (in fact, it allows the patient to be studied at the bedside, even in clinically unstable patients, it is well tolerated by patients, and it has no risks). CT has an excellent sensitivity in the diagnosis of postpartum infections, however, it has some drawbacks: it is not an examination that can be performed in clinically unstable patients, it cannot be performed at the patient's bedside, it has high costs, and it involves the administration of a significant dose of radiation . There are conflicting data in the literature regarding which examination is most useful for the diagnosis/management of infections in postpartum. Therefore, the investigators want to evaluate whether ultrasound alone, compared with management with combined ultrasound and CT scan, is a useful and sufficient diagnostic tool for the diagnosis and management of postpartum infectious complications.
Detailed description
Cases of infection recorded as a result of these parts will be reviewed. Laboratory tests and clinical data of these will be reviewed. Instrumental, ultrasound and CT images taken in the postpartum for diagnostic confirmation and subsequent follow-up will also be reviewed.
For each patient, information will be collected on:
- Age, weight, height
- Previous pregnancies and their outcome
- Pregnancy that arose spontaneously or through Medically Assisted Procreation techniques
- Conditions concomitant or complicating pregnancy
- Pregnancy outcome (spontaneous delivery or cesarean section)
- Laboratory tests
- Clinical data collected during hospitalization (vital parameters, symptoms, any medications administered)
- Radiologic (CT) or ultrasound (transabdominal and/or transvaginal) investigations performed during the hospital stay, in continuation-iter or in a subsequent hospitalization: name and model (and probe, for ultrasound examinations) of the equipment used will be specified for each examination performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It is planned to enroll patients who gave birth at the Operative Unit of Obstetrics and Prenatal Age Medicine of IRCCS AOUBO Policlinico di Sant'Orsola from 01/01/2017 to 31/12/2021.
Key inclusion criteria (12 listed)
- Women aged 18 years or older
- Diagnosis of postpartum infection (within 30 days after delivery).
- Clinical diagnosis is established by the following criteria (two or more of the following):
- Temperature >38°C or <36°C
- HR >100 bpm
Key exclusion criteria (1 listed)
- Women with localized or systemic infection following infection unrelated to delivery or incision site (in case of cesarean section), such as pneumonia, mastitis, influenza, COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of ultrasound signs of infection on ultrasonography
Time frame: Within 90 days after delivery
Presence of a hypoanechogenic area at the fascial level or hyperechogenic echoes at the level of the endometrial cavity. Ultrasound signs will be compared with CT scans of patients with established postpartum infection. CT scans are currently the gold standard for the diagnosis of infection, and investigators will rely on what is in the report in the medical record.
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 31 Jan 2025.
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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.
Elena Brunelli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Infection, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 12 inclusion and 1 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 31 Jan 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 Italy. 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.
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 Elena Brunelli, MD (05121414379, elena.brunelli9@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ultrasound signs of infection on ultrasonography (time frame: Within 90 days after delivery). 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 31 Jan 2025.