Placenta Accreta Spectrum Protocol
- Conditions
- Placenta Accreta
- Interventions
- Procedure: Planned Cesarean hysterectomyProcedure: Conservative management
- Registration Number
- NCT04384510
- Lead Sponsor
- Assiut University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1500
- Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- Women should be delivered by the corresponding center.
- Inadequate follow-up
- Authorization to use anonymous patient data for research purposes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with placenta accreta spectrum (PAS) Conservative management This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum Patients with placenta accreta spectrum (PAS) Planned Cesarean hysterectomy This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum
- Primary Outcome Measures
Name Time Method Failure of conservative management of placenta accreta spectrum (PAS) from delivery to 6 months after delivery Need for emergency or delayed hysterectomy following trial of conservative treatment
- Secondary Outcome Measures
Name Time Method Infectious morbidity after management of placenta accreta spectrum (PAS) From delivery and up to 6 weeks postpartum Incidence of sepsis and septic shock following interventions to manage PAS
Maternal blood loss From delivery and up to 24 hours postpartum Estimation 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 postpartum Incidence 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 postpartum Admission to ICU due to maternal instability
Trial Locations
- Locations (1)
Aswan Faculty of Medicine
🇪🇬Aswan, Egypt