Diagnosis and Outcomes of Placental Accretism

NCT06833606 | Recruiting

• 1 other identifier: PLC_AC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 7

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.

Conditions

Placenta Accreta

Keywords

diagnosis

Outcome Measures

Primary Outcomes (1)

• Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretism

  disappearance of the hypoecogenaretroplacental stria, lacunae placental vasculature, hypervascularization of the utero-vesical interface, interruption/irregularity of the bladder will be assessed by ultrasound

  Up to 1 month post-partum

Secondary Outcomes (1)

• Frequency of maternal complications (Surgical site infection)

  Up to 1 month post-partum

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (7)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale "M. Bufalini"

Cesena, Forlì-Cesena, 47521, Italy

RECRUITING

Ospedale "Morgagni-Pierantoni"

Forlì, Forlì-Cesena, 47121, Italy

RECRUITING

AOU Policlinico di Modena

Modena, Modena, 41100, Italy

RECRUITING

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, 43126, Italy

RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, 42123, Italy

RECRUITING

Ospedale "Infermi" di Rimini

Rimini, Rimini, 47900, Italy

RECRUITING

MeSH Terms

Conditions

Placenta Accreta; Disease

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluigi Pilu, MD

CONTACT

0512143493; gianluigi.pilu@aosp.bo.it

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: February 19, 2025
• Study Start: July 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2025

Record last verified: 2024-10

Locations

IT (7)