Diagnosis and Outcomes of Placental Accretism

Recruiting

• Conditions: Placenta Accreta

• Registration Number: NCT06833606
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2023-07-17
• Status Verified: 2024-10
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretism	Up to 1 month post-partum	disappearance of the hypoecogenaretroplacental stria, lacunae placental vasculature, hypervascularization of the utero-vesical interface, interruption/irregularity of the bladder will be assessed by ultrasound

Secondary Outcome Measures

Name	Time	Method
Frequency of maternal complications (Surgical site infection)	Up to 1 month post-partum	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

Trial Locations

Locations (7)

Ospedale "M. Bufalini"; 🇮🇹 Cesena, Forlì-Cesena, Italy

Ospedale "Morgagni-Pierantoni"; 🇮🇹 Forlì, Forlì-Cesena, Italy

AOU Policlinico di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliero - Universitaria di Parma; 🇮🇹 Parma, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Ospedale "Infermi" di Rimini; 🇮🇹 Rimini, Italy