NCT04384510

Placenta Accreta Spectrum Protocol

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: —

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

Detailed 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

Conditions

• Placenta Accreta

Interventions

Type	Name	Description
PROCEDURE	Planned Cesarean hysterectomy	This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy
PROCEDURE	Conservative management	This term describes a single or combined intervention of uterine artery ligation, internal iliac artery ligation, prophylactic balloon placement in the aorta or internal iliac artery, uterine artery embolization, compression sutures, or excision and reconstruction of uterine wall

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-08-31
• Completion: 2020-11-01
• First posted: 2020-05-12
• Last updated: 2020-05-12

Locations

1 site across 1 country: Egypt