Clinical trial NCT06760130: Retrospective Evaluation of Infections After Delivery
Official title: Retrospective Evaluation of Infections After Delivery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postpartum Infection
Keywords: ultrasound
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Presence of ultrasound signs of infection on ultrasonography
timeFrame: Within 90 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Elena Brunelli, MD
role: PRINCIPAL_INVESTIGATOR
References: