Association of Ultrasonographic Parameters With FIGO Clinical Grading System for Placenta Accreta Spectrum
1 other identifier
observational
158
0 countries
N/A
Brief Summary
To evaluate the association of ultrasonographic parameters suggestive of placenta accreta with intraoperative clinical diagnosis of placenta accreta according to the the clinical grading system for placenta accreta spectrum (PAS) disorders proposed recently by FIGO and histopathological diagnosis of placenta accreta in hysterectomy specimens
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 17, 2021
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedMarch 17, 2021
March 1, 2021
2 years
March 10, 2021
March 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate the association of ultrasonographic parameters with the intraoperative FIGO clinical grading for diagnosis of placenta accreta spectrum disorder and histopathological diagnosis of placenta accreta in hysterectomy specimens
Grade 1 : Complete placental separation at third stage, Grade 2 : removal of placenta required and parts of placenta thought to be abnormally adherent, Grade 3 : Manual removal of placenta required and the whole placental bed thought to be abnormally adherent, Grade 4 : Placental tissue seen to have invaded through the serosa of the uterus but a clear surgical plane can be identified between the bladder and uterus, Grade 5 : Placental tissue seen to have invaded through the serosa of the uterus and a clear surgical plane cannot be identified between the bladder and uterus, Grade 6 : Placental tissue seen to have invaded through the serosa of the uterus and infiltrating the parametrium or any organ other than the urinary bladder
Bseline
Secondary Outcomes (1)
Association of each ultrasonographic parameter of placental invasion with maternal and fetal complications
Baseline
Interventions
Association of each ultrasonographic parameter with FIGO clinical grading of placenta accreta and with histopathological diagnosis of placenta accreta in hysterectomy specimens
Eligibility Criteria
All females in age range between 18 years old and 45 years old who are diagnosed as placenta accreta spectrum disorder in antenatal care at Assiut University, Women Health Hospital at time between May 2021 and May 2023 will be included in the study
You may qualify if:
- All patients diagnosed with placenta previa previa or low lying placenta during pregnancy at any gestational age will be included and followed up until termination of pregnancy. The diagnosis of placenta previa was based on the presence of placental tissue overing the internal cervical os and Low-lying placenta was diagnosed when the placenta was within 2 cm from the internal cervical os but did not cover it
You may not qualify if:
- Impaired liver or renal functions.
- Coagulation disorders.
- Associated uterine pathology needing hysterectomy.
- Patient's refusal to participate in clinical research.
- Multiple pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assiut University, Women Health Hospital
Study Record Dates
First Submitted
March 10, 2021
First Posted
March 17, 2021
Study Start
May 1, 2021
Primary Completion
May 1, 2023
Study Completion
August 1, 2023
Last Updated
March 17, 2021
Record last verified: 2021-03