Diagnosis and Outcomes of Placental Accretism

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Gianluigi Pilu, MD; Phone Number: 0512143493; Email: gianluigi.pilu@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Gianluigi Pilu, MD; Phone Number: 0512143493; Email: gianluigi.pilu@aosp.bo.it
  • Modena, Italy, 41100
    • Recruiting
    • AOU Policlinico di Modena
    • Contact: Emma Bertucci, MD; Phone Number: 0594224180; Email: emma.bertucci@unimore.it
  • Parma, Italy, 43126
    • Recruiting
    • Azienda Ospedaliero - Universitaria Di Parma
    • Contact: Tullio Ghi, MD; Phone Number: 0521-033579; Email: tullio.ghi@unipr.it
  • Reggio Emilia, Italy, 42123
    • Recruiting
    • Arcispedale Santa Maria Nuova
    • Contact: Lorenzo Aguzzoli, MD; Phone Number: 0522335111; Email: aguzzoli.lorenzo@ausl.re.it
  • Rimini, Italy, 47900
    • Recruiting
    • Ospedale "Infermi" di Rimini
    • Contact: Federico Spelzini, MD; Email: federico.spelzini@gmail.com
  • Forlì-Cesena
    • Cesena, Forlì-Cesena, Italy, 47521
      • Recruiting
      • Ospedale "M. Bufalini"
      • Contact: Patrizio Antonazzo, MD; Phone Number: 0547352810; Email: Patrizio.antonazzo@auslromagna.it
    • Forlì, Forlì-Cesena, Italy, 47121
      • Recruiting
      • Ospedale "Morgagni-Pierantoni"
      • Contact: Luca Savelli, MD; Phone Number: 0543731867; Email: luca.savelli@auslromagna.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of maternal complications (Surgical site infection)	Post-operative haemorrhage and haemotransfusion, infection of the surgical site will be assessed by blood count with leucocyte formula, coagulation tests (thrombin time, thromboplastin time and fibrinogen), PCR (C-reactive protein), blood cultures	Up to 1 month post-partum

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Gianluigi Pilu, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: diagnosis
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: PLC_AC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No