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NCT Number: NCT06833606

Diagnosis and Outcomes of Placental Accretism

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.

Recruiting

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Frequency of correspondence between prenatal diagnosis and intra-operative finding of placental accretism

    Time frame: 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 outcomes

  1. Frequency of maternal complications (Surgical site infection)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluigi Pilu, MD

CONTACT

[email protected]

0512143493

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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