Placenta Accreta Spectrum Protocol

NCT ID: NCT04384510

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-11-30

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

Conditions

Placenta Accreta

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with placenta accreta spectrum (PAS)

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

Planned Cesarean hysterectomy

Intervention Type: PROCEDURE

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

Conservative management

Intervention Type: PROCEDURE

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

Interventions

Planned Cesarean hysterectomy

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Abdelkarim Mohammed Shazly

MBBCh, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aswan Faculty of Medicine

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sherif Shazly, MBBCh, MSc

Role: CONTACT

shazly.sherif2020@gmail.com

+201276791283

Facility Contacts

Amr S Abdelbadie, MBBCh, MD

Role: primary

love_like902@yahoo.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.

Reference Type: BACKGROUND

PMID: 28599899 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26002174 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29669225 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29405320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30260097 (View on PubMed)

Other Identifiers

PAS-ID

Identifier Type: -

Identifier Source: org_study_id