Placenta Accreta Spectrum Protocol

Assiut University

Status: Unknown

Conditions: Placenta Accreta

Treatments: Procedure: Planned Cesarean hysterectomy; Procedure: Conservative management

Study type: Observational

Funder types: Other

Identifiers

NCT04384510

PAS-ID

Details and patient eligibility

About

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

Full 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

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women diagnosed with PAS, aged between 18 to 48 years.
• Women should be delivered by the corresponding center.

Exclusion criteria

• Inadequate follow-up
• Authorization to use anonymous patient data for research purposes.

Trial design

1,500 participants in 1 patient group

Patients with placenta accreta spectrum (PAS)

Description:

This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum

Treatment:

Procedure: Planned Cesarean hysterectomy

Procedure: Conservative management