Placenta Accreta Spectrum Protocol
Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
1 other identifier
observational
1,500
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMay 12, 2020
May 1, 2020
6 months
May 8, 2020
May 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Maternal blood loss
From delivery and up to 24 hours postpartum
Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)
From delivery and up to 6 weeks postpartum
Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)
From delivery and up to 6 weeks postpartum
Infectious morbidity after management of placenta accreta spectrum (PAS)
From delivery and up to 6 weeks postpartum
Study Arms (1)
Patients with placenta accreta spectrum (PAS)
This cohort presents patients who were suspected or diagnosed either antenatal or intrapartum with placenta accreta spectrum
Interventions
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
Eligibility Criteria
Women diagnosed with placenta accreta spectrum (PAS) and managed in the recuriting hospitals between 2010 and 2020, who met study selection criteria
You may qualify if:
- Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- Women should be delivered by the corresponding center.
You may not qualify if:
- Inadequate follow-up
- Authorization to use anonymous patient data for research purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aswan Faculty of Medicine
Aswān, 81528, Egypt
Related Publications (5)
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.
PMID: 28599899BACKGROUNDSilver 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.
PMID: 26002174BACKGROUNDSilver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.
PMID: 29669225BACKGROUNDSentilhes 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.
PMID: 29405320BACKGROUNDJauniaux 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.
PMID: 30260097BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MBBCh, MSc
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 12, 2020
Study Start
March 1, 2020
Primary Completion
August 31, 2020
Study Completion
November 1, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share