Diagnosis and Outcomes of Placental Accretism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Placenta Accreta. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretism [Time frame: Up to 1 month post-partum]
Secondary outcome measures (1)
- Frequency of maternal complications (Surgical site infection) [Time frame: Up to 1 month post-partum]
Eligibility criteria
Inclusion criteria
- Age between 18 years and 44 years
- Pregnant women with suspected placental accretism
- Acquisition of informed consent form
Exclusion criteria
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 7 centers
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
- Ospedale "M. Bufalini" — Cesena
- Ospedale "Morgagni-Pierantoni" — Forlì
- AOU Policlinico di Modena — Modena
- Azienda Ospedaliero - Universitaria di Parma — Parma
- Arcispedale Santa Maria Nuova — Reggio Emilia
- Ospedale "Infermi" di Rimini — Rimini
Identifiers
NCT: NCT06833606 · PLC_AC