Diagnosis and Outcomes of Placental Accretism

NCT ID: NCT06833606

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-17

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placenta Accreta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gianluigi Pilu, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

Ospedale "M. Bufalini"

Cesena, Forlì-Cesena, Italy

Site Status RECRUITING

Ospedale "Morgagni-Pierantoni"

Forlì, Forlì-Cesena, Italy

Site Status RECRUITING

AOU Policlinico di Modena

Modena, Modena, Italy

Site Status RECRUITING

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, Italy

Site Status RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, Italy

Site Status RECRUITING

Ospedale "Infermi" di Rimini

Rimini, Rimini, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gianluigi Pilu, MD

Role: CONTACT

0512143493

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gianluigi Pilu, MD

Role: primary

0512143493

Patrizio Antonazzo, MD

Role: primary

0547352810

Luca Savelli, MD

Role: primary

0543731867

Emma Bertucci, MD

Role: primary

0594224180

Tullio Ghi, MD

Role: primary

0521-033579

Lorenzo Aguzzoli, MD

Role: primary

0522335111

Federico Spelzini, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLC_AC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Management of Placenta Accreta Spectrum
NCT04609527 UNKNOWN PHASE2/PHASE3