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Placenta Accreta Spectrum Protocol

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04384510
Enrollment
1500
Registered
2020-05-12
Start date
2020-03-01
Completion date
2020-11-30
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

Brief 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

Interventions

PROCEDUREPlanned Cesarean hysterectomy

This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Failure of conservative management of placenta accreta spectrum (PAS)from delivery to 6 months after deliveryNeed for emergency or delayed hysterectomy following trial of conservative treatment

Secondary

MeasureTime frameDescription
Maternal blood lossFrom delivery and up to 24 hours postpartumEstimation of blood loss during Cesarean section in ml
Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)From delivery and up to 6 weeks postpartumIncidence of urinary bladder and/or ureteric injury
Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)From delivery and up to 6 weeks postpartumAdmission to ICU due to maternal instability
Infectious morbidity after management of placenta accreta spectrum (PAS)From delivery and up to 6 weeks postpartumIncidence of sepsis and septic shock following interventions to manage PAS

Countries

Egypt

Contacts

Primary ContactSherif Shazly, MBBCh, MSc
shazly.sherif2020@gmail.com+201276791283

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026