Placenta Accreta Spectrum Protocol

Placenta Accreta Clinical Trial

Official title: Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol

Status Recruiting

Clinical Trial Summary

Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS

Clinical Trial Description

Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death

• The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate

• Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS

However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy

• Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited

• There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management ;

Related Conditions & MeSH terms

• Placenta Accreta

• NCT number: NCT04384510
• Study type: Observational
• Source: Assiut University
• Contact: Sherif Shazly, MBBCh, MSc
• Phone: +201276791283
• Email: shazly.sherif2020@gmail.com
• Status: Recruiting
• Start date: March 1, 2020
• Completion date: November 2020