Actively Recruiting

Age: 18Years - 44Years
FEMALE
ID06833606

Diagnosis and Outcomes of Placental Accretism

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-19

70

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the current main criteria used to diagnose placenta accreta and studying the maternal outcomes related to different management strategies for suspected placental accretism. The goal is to better understand the complications and improve standardization of care for affected pregnant women aged 18 to 44 years. This observational study is both retrospective and prospective and conducted across multiple centers nationally. Patients will receive treatment based on usual clinical practice. The study will collect and analyze key imaging and instrumental findings from cases of suspected accretism. It will compare outcomes between conservative management (cesarean section with placenta left in place) and more radical management (cesarean section with concurrent hysterectomy). Monitoring includes vital signs, laboratory tests, ultrasound, and other examinations during pregnancy, immediate postpartum, and follow-up visits. Participants will have visits twice a week during pregnancy unless complications arise. Postpartum follow-up depends on the procedure performed and any complications. Researchers will assess the agreement between prenatal diagnosis and surgical findings, as well as maternal complications such as surgical site infection up to one month after delivery. No questionnaires or rating scales are used. The study runs until December 31, 2026.

CONDITIONS

Brief Title

Diagnosis and Outcomes of Placental Accretism

Who Can Participate

Age: 18Years - 44Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 years and 44 years
  • Pregnant women with suspected placental accretism
  • Acquisition of informed consent form
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits depending on assessment of suspected placental accretism

Monitoring

Duration - Up to delivery (variable length)

Participants who undergo routine care are observed during pregnancy with clinical assessments including vital parameters, laboratory tests, ultrasound images, and instrumental examinations to evaluate progression.

Approximately twice weekly visits during pre-partum

Surgery and Immediate Post-operative Care

Duration - Up to hospital discharge (variable length)

Participants undergoing cesarean section with either conservative management (placenta in situ) or radical management (cesarean section with hysterectomy) are monitored during the immediate post-operative period.

Visits as per clinical care during hospital stay

Post-operative Follow-up

Duration - Up to 1 month post-partum

Participants are followed up after discharge to assess maternal and fetal outcomes, including the occurrence of complications and recovery, through outpatient visits and clinical assessments.

Outpatient follow-up visits depending on procedure and complications

Trial Site Locations

Total: 7 locations

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

2

Ospedale "M. Bufalini"

Cesena, Forlì-Cesena, Italy, 47521

Actively Recruiting

3

Ospedale "Morgagni-Pierantoni"

Forlì, Forlì-Cesena, Italy, 47121

Actively Recruiting

4

AOU Policlinico di Modena

Modena, Modena, Italy, 41100

Actively Recruiting

5

Azienda Ospedaliero - Universitaria di Parma

Parma, Parma, Italy, 43126

Actively Recruiting

6

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, Italy, 42123

Actively Recruiting

7

Ospedale "Infermi" di Rimini

Rimini, Rimini, Italy, 47900

Actively Recruiting

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Research Team

G

Gianluigi Pilu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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