Retrospective Evaluation of Infections After Delivery

NCT06760130 | Not Yet Recruiting

• 1 other identifier: INFPP_2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Infection

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Study Officials

• Elena Brunelli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Brunelli, MD

CONTACT

05121414379; elena.brunelli9@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2025

Record last verified: 2024-11

Locations

IT (1)