Placenta Accreta Spectrum Protocol

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Planned Cesarean hysterectomy
* Procedure: Conservative management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with placenta accreta spectrum (PAS)<br>This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum | Procedure: Planned Cesarean hysterectomy<br>* This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy<br>Procedure: Conservative management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of conservative management of placenta accreta spectrum (PAS) | Need for emergency or delayed hysterectomy following trial of conservative treatment | from delivery to 6 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal blood loss | Estimation of blood loss during Cesarean section in ml | From delivery and up to 24 hours postpartum | 
| Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS) | Incidence of urinary bladder and/or ureteric injury | From delivery and up to 6 weeks postpartum | 
| Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS) | Admission to ICU due to maternal instability | From delivery and up to 6 weeks postpartum | 
| Infectious morbidity after management of placenta accreta spectrum (PAS) | Incidence of sepsis and septic shock following interventions to manage PAS | From delivery and up to 6 weeks postpartum |