Placenta Accreta Spectrum Protocol

Overview

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 Title of Study: “Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 31, 2020

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

  • 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

Arms, Groups and Cohorts

  • Patients with placenta accreta spectrum (PAS)
    • This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum

Clinical Trial Outcome Measures

Primary Measures

  • Failure of conservative management of placenta accreta spectrum (PAS)
    • Time Frame: from delivery to 6 months after delivery
    • Need for emergency or delayed hysterectomy following trial of conservative treatment

Secondary Measures

  • Maternal blood loss
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: From delivery and up to 6 weeks postpartum
    • Admission to ICU due to maternal instability
  • Infectious morbidity after management of placenta accreta spectrum (PAS)
    • Time Frame: From delivery and up to 6 weeks postpartum
    • Incidence of sepsis and septic shock following interventions to manage PAS

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 48 Years

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sherif Abdelkarim Mohammed Shazly, MBBCh, MSc – Assiut University
  • Overall Contact(s)
    • Sherif Shazly, MBBCh, MSc, +201276791283, shazly.sherif2020@gmail.com

References

Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.

Silver RM, Barbour KD. Placenta accreta spectrum: accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2015 Jun;42(2):381-402. doi: 10.1016/j.ogc.2015.01.014.

Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.

Sentilhes L, Kayem G, Chandraharan E, Palacios-Jaraquemada J, Jauniaux E; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Conservative management. Int J Gynaecol Obstet. 2018 Mar;140(3):291-298. doi: 10.1002/ijgo.12410. No abstract available.

Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.

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