Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
1 other identifier
observational
21
1 country
1
Brief Summary
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2021
1 active site
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
June 18, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedDecember 8, 2022
December 1, 2022
1.6 years
June 18, 2021
December 7, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)
June 2021- July 2022
Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)
June 2021- July 2022
Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)
June 2021- July 2022
Secondary Outcomes (1)
1- Correlation between US signs and intraoperative findings including morbidity and mortality
June 2021- July 2022
Interventions
Ultrasound evaluation, with grayscale and color Doppler imaging.
Eligibility Criteria
21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)
You may qualify if:
- Age group 28:42 years.
- Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
- With a single living fetus in the current pregnancy.
- A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
- Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
You may not qualify if:
- Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
- Maternal chronic medical disorders( diabetes mellitus, hypertension)
- Patients presented with severe attack of bleeding.
- Patients presented with rupture of membrane.
- Emergency delivery regardless the cause.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo university Kasr Alainy OBGYN hospital
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 24, 2021
Study Start
June 18, 2021
Primary Completion
January 30, 2023
Study Completion
February 28, 2023
Last Updated
December 8, 2022
Record last verified: 2022-12