Placenta Accreta Spectrum Protocol

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384510
• Other study ID #: PAS-ID
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: November 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: Sherif Shazly, MBBCh, MSc
• Phone: +201276791283
• Email: shazly.sherif2020[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: November 2020
• Est. primary completion date: August 31, 2020
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Aswan Faculty of Medicine	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal blood loss	Estimation of blood loss during Cesarean section in ml	From delivery and up to 24 hours postpartum
Secondary	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
Secondary	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
Secondary	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