Retrospective Evaluation of Infections After Delivery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Infection

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Elena Brunelli, MD; Phone Number: 05121414379; Email: elena.brunelli9@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 90 days after delivery

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Elena Brunelli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: INFPP_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No