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Diagnosis and Outcomes of Placental Accretism

Diagnosis and Outcomes of Placental Accretism

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06833606
Enrollment
70
Registered
2025-02-19
Start date
2023-07-17
Completion date
2026-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

Keywords

diagnosis

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.

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretismUp to 1 month post-partumdisappearance of the hypoecogenaretroplacental stria, lacunae placental vasculature, hypervascularization of the utero-vesical interface, interruption/irregularity of the bladder will be assessed by ultrasound

Secondary

MeasureTime frameDescription
Frequency of maternal complications (Surgical site infection)Up to 1 month post-partumPost-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

Countries

Italy

Contacts

Primary ContactGianluigi Pilu, MD
gianluigi.pilu@aosp.bo.it0512143493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026