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Starting soon Observational

Retrospective Evaluation of Infections After Delivery

NCT06760130 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01
Last updated
2025-01-31

Condition(s) studied

Postpartum Infection

Study 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 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Presence of ultrasound signs of infection on ultrasonography — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06760130 on ClinicalTrials.gov ↗ ← All trials in Italy