Clinical trial NCT06833606: Diagnosis and Outcomes of Placental Accretism
Official title: Diagnosis and Outcomes of Placental Accretism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Placenta Accreta
Keywords: diagnosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected placental accretism/percretism followed at the Outpatient Clinics of the Division of Obstetrics and Prenatal Age Medicine at IRCCS-AOUBO Policlinico di Sant'Orsola and participating centers.

Brief summary: The goal of this observational study is to evaluate the diagnostic ability of the main criteria currently adopted for the diagnosis of placenta accreta and to define the maternal outcomes in terms of complications of the different management strategies currently adoptable when placental accretism is suspected.

Detailed description: Currently, the management of cases of placental accretism/percretism is not standardized. This study could help in assessing maternal and fetal outcomes related to the different therapeutic strategies applied in the clinical cases under study so that their management can be standardized in the near future.

This is a retrospective and prospective, national multicenter study. Patients will be treated according to clinical practice.

The main instrumental findings of cases of suspected accretism will be collected and analyzed, and the progression of pregnancy and postpartum (by means of laboratory and instrumental tests) will be evaluated in order to define the outcomes of conservative management (cesarean section with placenta in situ) versus more radical management (cesarean section and concomitant hysterectomy).

In particular, clinical trends (by means of assessment of vital parameters, laboratory tests, ultrasound images or instrumental examinations) in pregnancy, in the immediate postoperative period and during subsequent outpatient follow-up visits will be analyzed.

In general, in the absence of complications, visits will be performed twice a week during pre-partum. Postpartum follow-up is not standardized, as it will depend strictly on the procedure performed and the occurrence or absence of complications. There are no questionnaires and/or rating scales.

Eligibility criteria: Inclusion Criteria:

* Age between 18 years and 44 years
* Pregnant women with suspected placental accretism
* Acquisition of informed consent form

Exclusion Criteria:

None

Primary outcomes:
measure: Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretism
timeFrame: Up to 1 month post-partum
Secondary outcomes:
measure: Frequency of maternal complications (Surgical site infection)
timeFrame: Up to 1 month post-partum
Other outcomes:
Locations:
city: Cesena
country: Italy
facility: Ospedale "M. Bufalini"
state: Forlì-Cesena
city: Forlì
country: Italy
facility: Ospedale "Morgagni-Pierantoni"
state: Forlì-Cesena
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Parma
country: Italy
facility: Azienda Ospedaliero - Universitaria di Parma
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: Ospedale "Infermi" di Rimini
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Gianluigi Pilu, MD
role: PRINCIPAL_INVESTIGATOR
References: