NCT06833606

Diagnosis and Outcomes of Placental Accretism

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Placenta Accreta

Timeline

• Start date: 2023-07-17
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

7 sites across 1 country: Italy