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NCT Number: NCT05922397

Placenta Accreta Spectrum Topographic Classification

The present study is a prospective multicenter study consisting of a cohort of patients with prenatal or intraoperative diagnosis of PAS, evaluating the clinical outcomes of the group of patients found in each category of the topographic classification. In addition, an approach to evaluate the acceptability of this classification among the obstetrician-gynecologists of the participating medical centers will be included.

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Key information

Conditions

Placenta Accreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Fundación Valle del Lili

Cali, Colombia

Location status: Recruiting

Location contact

Albaro J Nieto-Calvache, M.D.

CONTACT

[email protected]

6023319090 ext. 3025

Albaro J Nieto-Calvache, M.D.

PRINCIPAL_INVESTIGATOR

About this study

The aim of this study is to describe the demographic and clinical characteristics of patients with a diagnosis of placenta accreta spectrum, and to determine the correlation between the topographic classification and the clinical outcomes found in the study. Finally, to evaluated whether the proposed classification is accepted by the obstetrician-gynecologists of the participating centers that manage placenta accreta spectrum patients.

It is an observational, multicentric study of a prospective cohort, in which data will be obtained from the medical records and other documents in each participating center, which are considered to be of routine use in day-to-day clinical practice. The study of the outcomes proposed in this protocol will be limited to those recorded in the clinical records and will be taken into account until the participant is discharged from the hospital, during which a surgical intervention was performed due to the suspicion or diagnosis of PAS.

It is projected that the period of patient enrollment will last 2 years, counting on from the first participant included. The study population is pregnant patients with a diagnosis of placenta accreta spectrum who visits any of the participating medical centers, and also obstetrician-gynecologists working in participating medical centers.

The centers invited to participate are hospitals or clinics that already have knowledge in how to apply the surgical staging of PAS, and the topographic classification and have experience using it.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant woman over 18 years old.
  • Prenatal diagnosis by ultrasound or MRI of Placenta Accreta Spectrum (PAS), regardless of the suspected degree of severity of the disease.
  • Case requiring surgical management, either as scheduled or emergent procedure.
  • Application of the topographic classification of placenta accreta spectrum during laparotomy.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Days of postoperative hospitalization

    Time frame: From the day the surgery is performed until the day of discharge or the date of death from any cause, whichever occurs first, evaluated up to 42 days.

    Number of days the patient was hospitalized from the day of surgery to the day of discharge

  2. Volume of intraoperative blood loss

    Time frame: During surgery

    Surgical bleeding calculated in milliliters

  3. Bladder injury

    Time frame: Up to 42 days postpartum

    Number of patients who had Bladder injuries

  4. Surgical reintervention

    Time frame: Up to 42 days postpartum

    Number of patients who need surgical reoperation after index surgery

  5. Complications associated with vascular interventions

    Time frame: Up to 42 days postpartum

    The patient presented thrombosis or other complication during post-surgery associated with vascular interventions.

  6. Maternal death

    Time frame: 24 months

    Does the patient die during this study

Study contacts

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

Albaro J Nieto-Calvache, MD

CONTACT

[email protected]

6023319090 ext. 4022

Daniela Sarria-Ortiz, MD

CONTACT

[email protected]

6023319090 ext. 3836

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

Evaluation of Clinical Outcomes and Acceptability of an Anatomical Classification for Placenta Accreta Spectrum, a Multicentric Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Feb 13, 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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