An observational study in Placenta Accreta, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 7 sites in Italy. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.
This study's planned enrollment of 70 is below the median of 87 across 78 observational studies indexed under Placenta Accreta.
Browse Placenta Accreta studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: Up to 1 month post-partum
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
Time frame: Up to 1 month post-partum
Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.
Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 41 months is above that.
How these figures are worked out, and which studies are left out of them.
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